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NCT Number: NCT06152588

Restricted Eating Time in the Treatment of Type 2 Diabetes

The overall aim of the present study is to investigate the effectiveness of implementing a 1-year time-restricted eating (TRE)-based intervention on glycaemic control, body weight and composition, cardiometabolic risk factors, and behaviour in individuals with overweight/obesity and type 2 diabetes (T2D).

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Key information

Conditions

Type 2 Diabetes Behavior Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Fasting Feeding Behavior Glucose Metabolism Disorders Intermittent Fasting Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Steno Diabetes Center Copenhagen

Herlev, Denmark, 2730

Location status: Recruiting

Location contact

Jonas S Quist, PhD

CONTACT

[email protected]

+4526176064

About this study

In people with type 2 diabetes (T2D), weight loss is associated with improved glycaemic control and markers of cardiometabolic function as well as reduced use of antidiabetic medicine. Beyond pharmacological treatments, current strategies to reduce body weight and improve glycaemia include energy-restricted diets and increased physical activity.

Lifestyle interventions are complex, affecting many aspects of peoples' daily life. Dietary restrictions often result in rapid weight loss but the weight is gradually regained by many. Barriers to implement and maintain dietary changes include relapse of old habits and lack of knowledge, support, and insights into the type and amount of foods eaten. Previous lifestyle interventions targeting weight loss in T2D show efficacy for improving markers of metabolic and cardiovascular risk, including body weight and glycaemia during the intervention, but weight regain is often present. One reason may be that the intervention is not modified according to the needs of the target group. Often, weight loss interventions are shaped by a 'one size fits all' approach where both individual capabilities and motivation as well as social and contextual factors are more or less ignored. A user-based design could facilitate enrolment of participants and promote implementation and maintenance of the intervention among participants.

Intermittent fasting regimens have been suggested as efficient strategies for improving cardiometabolic health to a greater extent than can be attributed to the reduction in energy intake alone. TRE limits the time available for food intake to typically 8-10 hours/day without other dietary restrictions and has been put forward as a novel, acceptable, and safe strategy that has shown promising effects on body weight, glucose metabolism, appetite, and cardiometabolic health in individuals at high risk of T2D.

Although it has been suggested that TRE is a safe and feasible intervention, the longer-term effectiveness of TRE on glycaemic control and weight loss in individuals with T2D is unknown alongside the long-term acceptability and sustainability. Additionally, potential social and contextual challenges associated with integration of TRE into ordinary daily life structure and routines call for new approaches to support the individual in implementing and maintaining the strategy.

Overall, the RESET2 study consists of three phases; 1) Need assessment, 2) Pilot study, and 3) RCT. The aim of the present study (RCT) is to investigate the effectiveness of implementing a 1-year TRE-based intervention in individuals with overweight/obesity and T2D. Participants will attend 6 visits at Steno Diabetes Center Copenhagen (SDCC): Visit 0 (screening), Visit 1 (baseline, minimum 10 days after screening), Visit 2 (10 days prior to visit 3), Visit 3 [3 months (12 weeks) after baseline], Visit 4 (10 days prior to visit 5), Visit 5 [12 months (52 weeks) after baseline].

The specific objectives are:

  • To investigate the effect of a 1-year TRE intervention on changes in glycaemic control (HbA1c) in individuals with overweight/obesity and T2D.
  • To investigate the effects of a 1-year TRE intervention on changes in body weight, fat mass, continuous glucose monitoring (CGM) recorded time in range (TIR 3.9-10.0 mmol/l), and use of antidiabetic medication in individuals with overweight/obesity and T2D.
  • To describe changes in cardiometabolic risk factors (including fat-free mass, blood lipids, markers of kidney and liver function and inflammation, hormones involved in glucose metabolism and appetite control, liver fat, blood pressure, waist- and hip circumference), time below range (TBR), time above range (TAB), cognition, food preferences and reward, dim light melatonin onset (DLMO), and patient-reported outcomes including self-rated health, physical activity, well-being, diabetes distress, depression, food intake, and sleep quality.
  • To investigate the effects of a 3-month TRE intervention on changes in brain insulin sensitivity (sub-study).
  • To describe the extent to which the intervention was conducted as planned (visits, conversations, phone calls, peer support activities).
  • To describe the extent to which participants participated in support-related activities.
  • To explore participants' experiences with following TRE throughout a year including how they managed to keep their eating window and how the supporting activities and individualized approach worked for them (sub-population).
  • To explore the results from objectives 1-7 in relation to the extent the participants adhered to eating windows.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age: ≥18 years
  • Overweight or obesity (BMI ≥25 kg/m2)
  • T2D with HbA1c>53 mmol/mol
  • Habitual eating window ≥12 h/day (incl. foods/snacks and energy-containing beverages)

Exclusion criteria

  • Bariatric surgery or planned bariatric surgery within study duration
  • Use of fast acting insulin and combination insulin products
  • Habitual CGM use
  • A wish to adhere to Ramadan
  • For women: current/planned pregnancy or lactation
  • Alcohol or drug abuse (judged by investigator) or treatment with disulfiram
  • Severe hypoglycaemia within last year (Severe hypoglycaemia, as defined by the American Diabetes Association (ADA), denotes severe cognitive impairment requiring external assistance for recovery)
  • Inability to understand written and oral information in Danish
  • Unable or unwilling to adhere to TRE; for instance, due to competing medical conditions.
  • Medical condition which, based on investigators assessment, challenges participation including but not limited to severe heart, vascular or lung disease, cancer, chemotherapy, psychiatric, gastrointestinal, rheumatic, or endocrine diseases etc.
  • Concomitant participation in other intervention study
  • Inability to perform neuropsychological tests (e.g., severe vision and hearing impairment that can-not be improved with aids such as glasses and hearing aids, or language barrier.)

Exclusion criteria

for the sub-study:

  • Magnetic resonance imaging (MRI) contraindications based on the MR department's exclusion criteria including pacemaker or other implanted electronic devices, implanted metal objects not compatible to MRI scanning and severe claustrophobia
  • Participants who do not wish to be informed about accidental findings by MR.

Treatment and study plan

Time restricted eating

Other

3 months (12 weeks) strict TRE intervention: Participants will be instructed to reduce their eating window by minimum 3 hours compared to habitual eating, with an eating window below 10 hours. The timing of the eating window is self-selected but should be placed between 6 am and 8 pm. Diet during the eating window is ad libitum with no further dietary restrictions.

9 months (40 weeks) individually adjusted TRE intervention: An individual plan will be made based on participants' experiences during the strict TRE. Different choices of individual adjustment and support will be provided, including 1) eating window adjustments and the possibility of 'days off', 2) provision of a list of allowed calorie and caffeine free beverages that can be consumed outside the window, 3) continued opportunity to participate in peer-support group meetings, 4) extra phone calls with a project worker to discuss challenges or strategies to continue with TRE etc., and 5) further involvement of relatives.

Primary outcomes

  1. Change in HbA1c (mmol/mol)

    Time frame: Change from baseline to 3-months of intervention (strict TRE)

    Assessed from blood samples in fasted state.

  2. Change in HbA1c (mmol/mol)

    Time frame: Change from baseline to the end of the intervention (12 months)

    Assessed from blood samples in fasted state.

Secondary outcomes

  1. Body weight (kg)

    Time frame: Change from baseline to end of the intervention (12 months). Measured at baseline, 3 months, 12 months

    Measured on a digital scale in a fasted state.

  2. Fat mass (kg)

    Time frame: Change from baseline to end of the intervention (12 months). Measured at baseline, 3 months, 12 months

    Measured by Dual-energy X-ray Absorptiometry in a fasted state.

  3. Time in range (% 3.9-10.0 mmol/l)

    Time frame: Change from baseline to end of the intervention (12 months). Measured at baseline, 3 months, 12 months

    Measured using continous glucose monitoring.

  4. Use of antidiabetic medication

    Time frame: Change from baseline to end of the intervention (12 months). Assessed at baseline, 3 months, 12 months.

    Change in current use of antidiabetic medication from baseline to end of the intervention (12 months).

Other outcomes

  1. Body weight (kg)

    Time frame: Change from baseline to 3 months

    Measured on a digital scale in a fasted state.

  2. Height (m)

    Time frame: Measured only at screening

    Height will be measured in order to calculate BMI.

  3. Body mass index (kg/m^2)

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

    Weight and height measurements will be used to calculate BMI in kg/m^2.

  4. Fat mass (kg)

    Time frame: Change from baseline to 3 months

    Measured by Dual-energy X-ray Absorptiometry in a fasted state.

  5. Time in range (% 3.9-10.0 mmol/l)

    Time frame: Change from baseline to 3 months

    Measured using continous glucose monitoring.

  6. Use of antidiabetic medication

    Time frame: Change from baseline to 3 months

    Change in current use of antidiabetic medication from baseline to 3 months

  7. Change in overall medication use

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

    Change in medication use (e.g. blood pressure, lipid-lowering medication etc)

  8. Blood lipids (mmol/l)

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

    Fasting concentrations of: Total cholesterol, LDL cholesterol, HDL cholesterol and triglycerides

  9. Fat free mass (kg)

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

    Measured by Dual-energy X-ray Absorptiometry in a fasted state.

  10. Hormones-Insulin (pmol/L)

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

    Fasting concentration of insulin

  11. Hormones-Glucagon (pmol/L)

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

    Fasting concentration of glucagon

  12. Hormones-C-peptide (pmol/L)

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

    Fasting concentration of C-peptide

  13. Hormones-Leptin (pmol/L)

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

    Fasting concentration of leptin

  14. Hormones-Fibroblast growth factor 21 (pmol/L)

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

    Fasting concentration of fibroblast growth factor 21

  15. Hormones-Glucagon-like peptide-1 (pmol/L)

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

    Fasting concentration of glucagon-like peptide-1

  16. Hormones-Glucose-dependent insulinotropic polypeptide (pmol/L)

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

    Fasting concentration of glucose-dependent insulinotropic polypeptide

  17. Hormones-Ghrelin (pmol/L)

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

    Fasting concentration of ghrelin

  18. Hormones-Peptide YY (pmol/L)

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

    Fasting concentration of peptide YY

  19. Hormones-Neuropeptide Y (pmol/L)

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

    Fasting concentration of neuropeptide Y

  20. Hormones-Growth differentiating factor 15 (pmol/L)

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

    Fasting concentration of growth differentiating factor 15

  21. Marker of kidney function - Creatinine (µmol/L)

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

    Fasting concentration of creatinine

  22. Marker of kidney function - eGFR (mL/min)

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

    Estimated glomerular filtration rate (eGFR)

  23. Plasma beta-hydroxybutyrate (mmol/L)

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

    Fasting concentration of plasma beta-hydroxybutyrate

  24. Marker of liver function - Aspartate-aminotransferase (U/L)

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

    Fasting concentration of aspartate-aminotransferase

  25. Marker of liver function - Alanine aminotransferase (U/L)

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

    Fasting concentration of alanine-aminotransferase

  26. Marker of liver function - Thrombocytes (x10^9/L)

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

    Fasting concentration of thrombocytes (for estimating liver-fibrosis)

  27. Markers of inflammation- Tumor necrosis factor alpha (pmol/L)

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

    Fasting concentration of Tumor necrosis factor alpha

  28. Markers of inflammation-Adiponectin (pmol/L)

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

    Fasting concentration of adiponectin

  29. Markers of inflammation-C-reactive protein (mg/L)

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

    Fasting concentration of C-reactive protein

  30. Markers of inflammation-Interleukin 6 (pmol/L)

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

    Fasting concentration of interleukin 6

  31. Time Below Range (% <3.9 mmol/l)

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

    Measured using continous glucose monitoring.

  32. Time Above Range (% >10.0 mmol/l)

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

    Measured using continous glucose monitoring.

  33. Coefficient of variation (CV) of glucose concentrations

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

    Measured using continous glucose monitoring.

  34. Mean glucose concentrations

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

    Measured using continous glucose monitoring.

  35. Standard deviation of glucose concentrations

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

    Measured using continous glucose monitoring.

  36. Systolic blood pressure (mmHg)

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

    Measured in a fasted and rest state.

  37. Diastolic blood pressure (mmHg)

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

    Measured in a fasted and rest state.

  38. Resting heart rate (bpm)

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

    Measured in a fasted and rest state.

  39. Waist circumference (cm)

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

    Measured using tape measure in a fasted state. The average of three consecutive measurements is reported.

  40. Hip circumference (cm)

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

    Measured using tape measure in a fasted state.The average of three consecutive measurements is reported.

  41. Waist/hip ratio

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

    The ratio of the circumference of the waist to that of the hips.

  42. Degree of liver fibrosis (kPa)

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

    Measured by FibroScan in a fasted state.

  43. Degree of liver steatosis (dB/m)

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

    Measured by FibroScan in a fasted state.

  44. Food choice

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

    Food choice of food items from four combined food categories (high-fat savoury, high-fat sweet, low-fat savoury and low-fat sweet foods) examined from the Steno Biometric Food Preference Task (SBFPT). Food choice is determined based on frequency of selection made within each food category. The scores range from 0-48 i.e. 0 = foods within a specific food category have not been selected at all to 48 = foods within a specific food category have been selected 48 times.

  45. Attention

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

    Measured using eye tracking in response to looking at food pictures during the SBFPT.

    Includes the following parameters: Gaze: Time spent (ms and %) and revisits (n); and fixations: Time to first fixation (ms), time spent (ms and %), fixation count (n), first fixation duration (ms), average fixation duration (ms). Distance to screen (mm), and gaze direction bias (ratio) which is calculated as the number of trials in which the first fixation was directed to a food image as a proportion to all trials. A bias score >0.5 indicates attention towards one food image, a bias score equal to 0.5 indicates no bias, and a bias score <0.5 indicates attention towards the other food images.

  46. Reaction time (ms)

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

    Reaction time during forced food choice of food items from four combined food categories (high-fat savoury, high fat sweet, low-fat savoury and low-fat sweet foods) examined from the SBFPT.

  47. Explicit liking

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

    Explicit liking of 16 food items from four combined food categories (high-fat savoury, high-fat sweet, low-fat savoury and low-fat sweet foods) examined from the SBFPT. Explicit liking is rated using visual analogue scales (VAS) and the range is 0-100. Each end represents the extremes e.g. Question: "how pleasant would it be to taste this food right now?" Answer: "not at all" (rated 0 on the 0-100 scale) to "extremely" (rated 100 on the 0-100 scale).

  48. Explicit wanting

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

    Explicit wanting of 16 food items from four combined food categories (high-fat savoury, high-fat sweet, low-fat savoury and low-fat sweet foods) examined from the SBFPT. Explicit wanting is rated using VAS and the range is 0-100. Each end represents the extremes e.g. Question: "how much do you want some of this food now?" Answer: "not at all" (rated 0 on the 0-100 scale) to "extremely" (rated 100 on the 0-100 scale).

  49. Implicit wanting

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

    Implicit wanting of food items from four combined food categories (high-fat savoury, high-fat sweet, low-fat savoury and low-fat sweet foods) examined from the SBFPT. Implicit wanting is assessed based on food choice and response time for selected and non-selected food items as well as mean response time (a frequency-weighted algorithm).

    In this frequency-weighted algorithm a positive score indicates a more rapid preference for a food type over another food type and a negative score indicates the opposite. A score of zero indicates that food types are equally preferred.The frequency weighted algorithm is used so the implicit wanting score is influenced by both selection (positively contributing to the score) and non-selection (negatively contributing to the score) of food type. Scores for implicit wanting typically range from -100-100 (due to reaction time there is no fixed min-max value).

  50. Self-reported binge eating disorder

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

    Assessed from 2 questions (question 13,14) of Binge Eating Disorder Examination Questionnaire (EDE-Q 6.0).

  51. Self-reported physical activity

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

    Assessed from the Physical Activity Scale 1 (PAS1)

  52. Self-reported sleep quality

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

    Assessed from the Pittsburgh Sleep Quality Index (PSQI).The questionnaire consists of 19 items. Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.

  53. Self-reported information on social relations and social support

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

    Assessed from 2 items (items 68 and 70) of social relations and social support questionnaire (the Danish National Health Survey, item 68 and 70). The questions refer to contact with other people.

  54. Self-reported sleepiness

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

    Assessed from the Epworth Sleepiness Scale (ESS).The questionnaire consists of 8 questions, which is weighted on a 0-3 interval scale. A low total score can be interpreted as a normal daytime sleepiness, and a higher score as a mild, moderate and severe excessive daytime sleepiness, respectively.

  55. Self-reported eating behavior

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

    Assessed from the Dutch Eating Behavior Questionnaire (DEBQ). The questionnaire consists of 33 items and comprises three scales that measure emotional, external and restrained eating.Items can be rated from 1 (never) to 5 (very often), with higher scores indicating greater endorsement of the eating behavior.

  56. Self-reported night eating

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

    Assessed from the Night Eating Questionnaire (NEQ). The questionnaire consists of 14 items, that can be rated from 0 to 4. All items except item 13 are summed to obtain a global score. A total score ≥ 25 has been proposed as a lenient threshold for night eating syndrome.

  57. Self-reported food intake

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

    Assessed from the food intake questionnaire (23-item FFQ). The questionnaire collects dietary data and uses a context-specific food list to estimate the usual diet.

  58. Self-reported diabetes distress

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

    Assessed from the Problem Areas in Diabetes Scale (PAID-5 scale) comprising five of the emotional-distress questions of the full PAID items. Each item can be rated from 0 to 4. A total score of ≥ 8 indicates possible diabetes related emotional distress.

  59. Self-reported sexual functioning/well-being

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

    Assessed from 1 item of the questionnaire the Danish National Health Survey (item 79) and 4 items of the questionnaire Danish PRO scheme (diabetes) (item 46 and 63-65).

  60. Self-reported mood

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

    Assessed from the Major Depression Inventory (MDI). The questionnaire consists of 10 items. Each item can be rated from 0 to 5.The total score ranges from 0 to 50. A total score <20 indicates depression does not exist or its existence is doubtful, 20-24 indicates mild depression, 25-29 indicates moderate depression, and >29 indicates severe depression.

  61. Self-assessed questionnaire to determine morningness-eveningness in human circadian rhythm

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

    Assessed by the Morningness-Eveningness Questionnaire (MEQ). The questionnaire consists of 19 items. Each item can be rated from 0 to 4-7. The total score ranges from 16 to 86. The lower score the more eveningness, and the higher score the more morningness.

  62. Subjective appetite

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

    Subjective appetite will be assessed using Visual analogue scales (VAS), including ratings of hunger, fullness, satiety and prospective food consumption, thirst, desire to eat something sweet, salty, fatty, meat, and potential nausea.

  63. Cognition

    Time frame: Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

    Cognitive functions will be assessed by Screen for Cognitive Impairment in Psychiatry Danish Version (SCIP-D) together with the Trail Making Test-Part B (psychomotor speed and executive function) and the Cognitive Failures Questionnaire

  64. Dim light melatonin onset (DLMO) (subgroup only)

    Time frame: Change from baseline to 3 months. Measured at baseline and 3 months

    DLMO is a standard biomarker for measuring circadian rhythms and can easily be measured at home by saliva sampling. Saliva samples must be taken every 60 minutes under dim light (<30 lux) for at least 1 hour prior to and throughout the expected rise in melatonin.

  65. Brain insulin resistance (subgroup only)

    Time frame: Change from baseline to 3 months. Assessed at baseline and 3 months.

    Cerebral blood flow assessed by MRI in response to intranasal insulin administration in a subgroup of participants. A basal MRI will be conducted and afterwards 160 U insulin will be administered intranasally by spraying 2 puffs per nostril (each containing 10 U of insulin) every minute over 4 minutes followed by MRI 30 minutes after the last administration

  66. Adherence (%)

    Time frame: Registered 2 days/week on random days via an online questionnaire.

    Degree of adherence to eating windows = (number of days where eating window was reduced by minimum 3 hours compared to habitual eating window and participants have reported an eating window below 10 hours / total number of days in intervention) * 100%.

  67. Degree of participants' participation in intervention activities - Visits

    Time frame: Visit 1, visit 2, visit 3, visit 4, visit 5

    Assessed from % participation in the 5 intervention visits

  68. Degree of participants' participation in intervention activities - Conversations

    Time frame: Conversations at visit 1 and visit 3

    Assessed from % participation in the conversations at visit 1 and 3 (TRE group only)

  69. Degree of participants' participation in intervention activities - Peer support group meetings

    Time frame: Support group meetings will be held once monthly

    Assessed from % participation in peer support group meetings (TRE group only)

  70. Degree of participants' participation in intervention activities - Phone calls

    Time frame: Phone calls after 2, 6, 9 weeks + Phone calls after 6 and 9 months

    Assessed from % participation in the phone calls (TRE group only)

  71. Participants' acceptance of TRE

    Time frame: The interviews will be conducted at the end of intervention (1 year after baseline) at visit 5

    Assessed by interviews on participants' acceptance of TRE in terms of bodily/physical experiences, motivation, and ability to manage TRE in daily living and how intervention activities were supportive. This refers only to the TRE group. Individual interviews will be conducted by a qualitative researcher with a sub-group of participants in the TRE group (n=30) representing experiences with a variety of individual adjustments after the last visit, and focus group interviews will be performed with a sub-group of participants in the TRE group (n=30) choosing peer support or family involvement. Participants are free to say yes or no to participate in interviews.These interviews will be audio recorded.

  72. Energy intake (kJ)

    Time frame: Registrations prior to baseline (visit 1), after 3 months (visit 3), and after 12 months (visit 5)

    Assessed from 3-day dietary records

  73. Fat energy percent

    Time frame: Registrations prior to baseline (visit 1), after 3 months (visit 3), and after 12 months (visit 5)

    Assessed from 3-day dietary records

  74. Carbohydrate energy percent

    Time frame: Registrations prior to baseline (visit 1), after 3 months (visit 3), and after 12 months (visit 5)

    Assessed from 3-day dietary records

  75. Protein energy percent

    Time frame: Registrations prior to baseline (visit 1), after 3 months (visit 3), and after 12 months (visit 5)

    Assessed from 3-day dietary records

  76. Alcohol energy percent

    Time frame: Registrations prior to baseline (visit 1), after 3 months (visit 3), and after 12 months (visit 5)

    Assessed from 3-day dietary records

  77. Dietary fibers (gram)

    Time frame: Registrations prior to baseline (visit 1), after 3 months (visit 3), and after 12 months (visit 5)

    Assessed from 3-day dietary records

Study contacts

Contact information is provided by the study sponsor or research team.

Jonas S Quist, PhD

CONTACT

[email protected]

+45 26176064

Sponsors and collaborators

Lead sponsor

Steno Diabetes Center Copenhagen

Other

Collaborators

  • Glostrup University Hospital, Copenhagen
  • Salk Institute for Biological Studies
  • University of Copenhagen
  • University of Leeds

Registry information

Official study title

Restricted Eating Time in the Treatment of Type 2 Diabetes - the RESET2 Trial.

Acronym: RESET2

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 30, 2023
Registry last updated
May 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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