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Completed

NCT Number: NCT05225337

Time Restricted Eating for the Treatment of Type 2 Diabetes

Innovative lifestyle strategies to treat type 2 diabetes (T2DM) are critically needed. At present, daily calorie restriction (CR) is the main diet prescribed to patients with T2DM for weight loss. However, many patients find it difficult to adhere to CR because calorie intake must be vigilantly monitored every day.

In light of these problems with CR, another approach that limits timing of food intake, instead of number of calories consumed, has been developed. This diet is called "time restricted eating" (TRE) and involves confining the period of food intake to 6-8 h per day. TRE allows individuals to self-select foods and eat ad libitum during a large part of the day, which greatly increases compliance to these protocols. Recent findings show that TRE is effective for weight loss and improved glycemic control in patients with obesity and prediabetes. However no long-term randomized controlled trial has examined whether TRE is safe and effective for patients with obesity and T2DM.

This study is a 6-month randomized, controlled trial that aims to compare the effects of TRE (eating all food between 12:00 pm to 8:00 pm, without calorie counting), versus CR (25% energy restriction daily), and a control group eating over a period of 10 or more hours per day, on change in body weight (%), glycemic control, and cardiometabolic risk factors, in adults with obesity and T2DM.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Illinois Chicago

Chicago, Illinois, 60612, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 18-80 years
  • BMI between 30 and 50 kg/m2
  • Previously diagnosed with type 2 diabetes
  • HbA1c between 6.5 and 11%
  • Sedentary or lightly active

Exclusion criteria

  • HbA1c below 6.5 or greater than 11%
  • Have a history of cardiovascular disease
  • History of eating disorders (anorexia, bulimia, or binge eating disorder)
  • Not weight stable for 3 months prior to the beginning of study (weight gain or loss > 4%)
  • Eating within less than a 10 hour window at baseline
  • Perimenopausal (menses does not appear every 27-32d)
  • Pregnant, or trying to become pregnant
  • Night shift workers
  • Smokers

Treatment and study plan

Time restricted feeding (TRF)

Other

8-h eating window Ad libitum food intake from 12-8 pm every day Fasting from 8-12 pm every day (16-h fast)

Daily calorie restriction

Other

25% energy restriction every day Diet counseling provided

Primary outcomes

  1. Change in percent body weight

    Time frame: Measured at baseline and month 6

    Measured by an electronic scale

Secondary outcomes

  1. Change in HbA1c

    Time frame: Measured at baseline and month 6

    Measured by outside lab (Medstar, IN)

  2. Change in total time in euglycemic range

    Time frame: Measured at baseline and month 6

    Measured by continuous glucose monitor (CGM)

  3. Change in mean glucose level

    Time frame: Measured at baseline and month 6

    Measured by continuous glucose monitor (CGM)

  4. Change in standard deviation of glucose level

    Time frame: Measured at baseline and month 6

    Measured by continuous glucose monitor (CGM)

  5. Change fasting glucose

    Time frame: Measured at baseline and month 6

    Measured by outside lab (Medstar, IN)

  6. Change fasting insulin

    Time frame: Measured at baseline and month 6

    Measured by outside lab (Medstar, IN)

  7. Change in Insulin sensitivity

    Time frame: Measured at baseline and month 6

    Measured as QUICKI

  8. Change in insulin resistance

    Time frame: Measured at baseline and month 6

    Measured as HOMA-IR

  9. Change in absolute body weight

    Time frame: Measured at baseline and month 6

    Measured by electronic scale

  10. Change in fat mass, lean mass, visceral fat mass

    Time frame: Measured at baseline and month 6

    Measured by DXA

  11. Change in waist circumference

    Time frame: Measured at baseline and month 6

    Measured by measuring tape

  12. Change in body mass index (BMI)

    Time frame: Measured at baseline and month 6

    Calculated as kg/meter squared

  13. Change in plasma lipids (total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides)

    Time frame: Measured at baseline and month 6

    Measured by outside lab (Medstar, IN)

  14. Change in systolic and diastolic blood pressure

    Time frame: Measured at baseline and month 6

    Measured by blood pressure cuff

  15. Change in heart rate

    Time frame: Measured at baseline and month 6

    Measured by blood pressure cuff

  16. Change in energy and nutrient intake

    Time frame: Measured at baseline and month 6

    Measured by 7-day food record

  17. Change in dietary adherence

    Time frame: Measured at baseline, month 3, and month 6

    Measured by 7-day food record and adherence log

  18. Change in physical activity (steps/d)

    Time frame: Measured at baseline and month 6

    Measured by pedometer

  19. Adverse events

    Time frame: Measured weekly from baseline to month 6

    Measured by adverse events survey

  20. Change in medication effect score (MES)

    Time frame: Measured at baseline and month 6

    Measured by survey. Total score 0-100. Lower scores indicate less medication used, higher scores indicate more medication used.

  21. Change in sleep quality

    Time frame: Measured at baseline and month 6

    Measured by Pittsburgh Sleep Quality Index (PSQI), total score of 0-21. A PSQI total score greater than 5 indicates poor sleep quality.

  22. Change in insomnia severity

    Time frame: Measured at baseline and month 6

    Measured by Insomnia Severity Index (ISI), total score of 0-28. The total score for the ISI is interpreted as follows: no clinically significant insomnia (0-7), sub-threshold insomnia (8-14), moderate severity insomnia (15-21), and severe insomnia (22-28).

  23. Change in risk of sleep apnea

    Time frame: Measured at baseline and month 6

    Measured by Berlin Questionnaire, measures proportion of participants at high risk for sleep apnea

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Feb 4, 2022
Registry last updated
Nov 27, 2024

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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