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Completed

NCT Number: NCT03761186

Comparison of Low, Moderate and High Carbohydrate Diet on Insulin Requirements and Metabolic Control in Type 1 Diabetes

The scientific basis for dietary recommendations in type 1 diabetes is almost lacking, with the current recommendations being based on type 2 diabetes studies. Therefore the overall purpose of this study is to improve the current evidence for dietary recommendations to people with type 1 diabetes.

Study aim: To compare how a strictly low carbohydrate diet, a moderately low carbohydrate diet and a traditional diabetes diet (with higher amounts of carbohydrates) affect insulin requirements and metabolic control in individuals with type 1 diabetes.

Carbohydrate intake is 50-60% of the total energy intake in the traditional diabetes diet, 30-40% in the moderately low carbohydrate diet and 15-20% in the strictly low carbohydrate diet with a minimum of 50 g carbohydrates/day. A diet with less than 50 g carbohydrates/day is usually called very low carbohydrate diet or ketogenic and will not be tested in this study.

Those who wish to participate and meet the inclusion criteria (and none of the exclusion criteria) will be randomized to one of the three diets. The duration of the intervention is 6 months after which the participants will be able to choose their own diet for another 6 months. The main study visits are at baseline (screening and study start), 3, 6, 9, and 12 months. Shorter visits will be at 3 and 6 weeks. The participants will meet with a study nurse, dietitian and doctor. They will attend two carbohydrate counting courses before the start of the intervention in order to be able to match their insulin to the amount carbohydrates they eat. Participants will receive written materials about their diets with menus and recipes for better adherence to the diet.

The primary endpoint is the change in insulin requirements within and between groups (for secondary endpoints please see relevant section). For assessing the different endpoints the participants will provide blood, urine and feces samples for lab analyses as well as register their insulin use, blood glucose, diet, physical activity and any blood ketones or hypoglycemia electronically or in written forms. Continuous/flash glucose monitoring (CGM/FGM) will be also used. Dietary assessment and adherence will be based on 3-4 day food diaries before every scheduled study visit.

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Key information

Conditions

Type1diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Immune System Diseases Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Diabetes, Academic Specialistcenter

Stockholm, 11365, Sweden

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • To have had type 1 diabetes for at least 1 year
  • Age >=20 years old

Exclusion criteria

  • Cardiovascular disease NYHA class IIIB or more
  • Kidney disease > stadium 3
  • Liver disease, alanine aminotransferase (ALAT) ≥ 2 µkat/L,
  • BMI < 18.5 kg/m^2
  • c-peptide ≥ 0.3 nmol/l
  • Pregnant/breastfeeding women, women that plan to get pregnant during study period
  • Other circumstances, which, according to the examiner, make it difficult for an individual to participate.

Treatment and study plan

traditional diabetes diet

Behavioral

Diet with carbohydrate content 50-60% of total energy intake

moderately low carbohydrate diet

Behavioral

Diet with carbohydrate content 30-40% of total energy intake

strictly low carbohydrate diet

Behavioral

Diet with carbohydrate content 15-20% of total energy intake

Primary outcomes

  1. Change in insulin use

    Time frame: screening, day 0, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months

    measured in international units (IU) and percentage.

Secondary outcomes

  1. Change in HbA1c

    Time frame: screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months

    mmol/mol

  2. Change in concentration of total cholesterol

    Time frame: screening, 3 months, 6 months, 9 months, 12 months

    mmol/L

  3. Change in concentration of triglycerides

    Time frame: screening, 3 months, 6 months, 9 months, 12 months

    mmol/L

  4. Change in concentration of HDL-cholesterol

    Time frame: screening, 3 months, 6 months, 9 months, 12 months

    mmol/L

  5. Change in concentration of LDL-cholesterol

    Time frame: screening, 3 months, 6 months, 9 months, 12 months

    mmol/L

  6. Ratio of LDL/HDL

    Time frame: screening, 3 months, 6 months, 9 months, 12 months

    absolute number

  7. Concentration of glucagon

    Time frame: screening, 3 months, 6 months, 9 months, 12 months

    pmol/L

  8. Change in markers of glycemic variability (TIR, TAR, TBR, mean sensor glucose with SD, CV)

    Time frame: screening, 3 months, 6 months, 9 months, 12 months

    mmol/L

  9. Change in weight

    Time frame: screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months

    kg

  10. Change in BMI

    Time frame: screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months

    kg/m^2

  11. Change in abdominal circumference

    Time frame: screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months

    cm

  12. Change in concentration of p-creatinine

    Time frame: screening, 3 months, 6 months, 9 months, 12 months

    micromol/L

  13. Change in estimated Glomerular Filtration Rate (eGFR)

    Time frame: screening, 3 months, 6 months, 9 months, 12 months

    mL/min/1,73 m2

  14. Change in microalbuminuria

    Time frame: screening, 3 months, 6 months, 9 months, 12 months

    morning U-Alb/Crea (mg/mmol)

  15. Concentration of Insulin-like Growth Factor 1 (IGF-I)

    Time frame: screening, 3 months, 6 months, 9 months, 12 months

    microg/L

  16. Concentration of Insulin-like Growth Factor - binding protein 1 (IGFBP-1)

    Time frame: screening, 3 months, 6 months, 9 months, 12 months

    microg/L

  17. Concentration of leptin

    Time frame: screening, 3 months, 6 months, 9 months, 12 months

    microg/L

  18. Concentration of adiponectin

    Time frame: screening, 3 months, 6 months, 9 months, 12 months

    mg/L

  19. Concentration of interleukin 6 (IL-6)

    Time frame: screening, 3 months, 6 months, 9 months, 12 months

    ng/L

  20. Concentration of high sensitivity c-Reactive Protein (Hs-CRP)

    Time frame: screening, 3 months, 6 months, 9 months, 12 months

    mg/L

  21. Measurement of lipopolysaccharides (LPS) activity using the Limulus Amebocyte Lysate (LAL) assay

    Time frame: screening, 3 months, 6 months, 9 months, 12 months

    measured in endotoxin units (EU)/ml

  22. Concentration of glutaredoxin 1 (GRX-1)

    Time frame: screening, 3 months, 6 months, 9 months, 12 months

  23. Concentration of Oxidized LDL

    Time frame: screening, 3 months, 6 months, 9 months, 12 months

  24. Total Antioxidant Capacity (TAC)

    Time frame: screening, 3 months, 6 months, 9 months, 12 months

  25. Concentration of reactive oxygen species (ROS)

    Time frame: screening, 3 months, 6 months, 9 months, 12 months

  26. Plasma metabolites assessed by untargeted liquid chromatography - mass spectrometry (LC-MS) metabolomics

    Time frame: screening, 3 months, 6 months, 9 months, 12 months

  27. Score from the Short Form 36 (SF-36) questionnaire

    Time frame: screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months

    The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health.The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.

  28. Score from the Well-being Questionnaire-12 (WBQ-12)

    Time frame: screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months

    This questionnaire is designed to measure general well-being, including negative well-being, energy and positive well-being. The negative well-being scale score (range 0-12) is reversed and then summed with the Energy score (range 0-12) and Positive score (range 0-12) to produce a general well-being score (range 0-36). The higher the score the greater the sense of general well-being.

  29. Score from the Diabetes Treatment Satisfaction Questionnaire (DTSQ)

    Time frame: screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months

    The DTSQ has been developed to assess patient satisfaction with diabetes treatment. The questionnaire is composed of two different factors. The first factor assesses treatment satisfaction and consists of six questions and the second factor consists of two questions, which assess the burden from hyper- and hypoglycemia. Treatment satisfaction is assessed as the sum of the scores of the six questions on the first factor (total score 36), with a higher score indicating higher treatment satisfaction.

  30. Time taken to complete the Trail making test A+B

    Time frame: screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months

    The Trail Making Test is a neuropsychological test of visual attention and task switching. It consists of two parts in which the subject is instructed to connect a set of 25 dots as quickly as possible while still maintaining accuracy. The time taken to complete the test is used as the primary performance metric, measured in seconds and or minutes.

Other outcomes

  1. Carbohydrate intake

    Time frame: screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months

    in grams/day

  2. Energy intake from carbohydrates

    Time frame: screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months

    % of total energy intake

  3. Daily energy intake of participants

    Time frame: screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months

    kcal/day

  4. Frequency of intake of different foods measured by a Food frequency questionnaire (FFQ)

    Time frame: screening, 6 months,12 months

    The participants will fill in how frequent they consume 132 different food items. The available frequency responses are: 0/month, 1-3/month, 1-2/week, 3-4/week, 5-6/week, 1/day, 2/day, 3+/day.

Sponsors and collaborators

Lead sponsor

Anneli Björklund

Other

Collaborators

  • Uppsala University Hospital

Registry information

Official study title

DANCE (Diabetes ANd CarbohydratEs). Does the Amount of Dietary Carbohydrates Affect Insulin Requirements and Metabolic Control in Type 1 Diabetes? Comparative Study of Traditional Diabetes, Moderately Low and Strictly Low Carbohydrate Diet

Acronym: DANCE

Important dates

Study start
2018
Primary completion
2023
Study completion
2024
First posted
Dec 3, 2018
Registry last updated
Jul 20, 2026

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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