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Trial record 3 of 14 for:    "Dietary Carbohydrates" | Recruiting, Not yet recruiting, Available Studies

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

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ClinicalTrials.gov Identifier: NCT03761186
Recruitment Status : Not yet recruiting
First Posted : December 3, 2018
Last Update Posted : December 3, 2018
Sponsor:
Collaborator:
Uppsala University Hospital
Information provided by (Responsible Party):
Anneli Björklund, Karolinska Institutet

Brief Summary:

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.

Recruitment areas are Stockholm and Uppsala. 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 for 3-7 days before study visits. Dietary assessment and adherence will be based on 3-day food diaries before every scheduled study visit.


Condition or disease Intervention/treatment Phase
Type1diabetes Behavioral: traditional diabetes diet Behavioral: moderately low carbohydrate diet Behavioral: strictly low carbohydrate diet Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Nurses that will take lab samples as well as laboratory personal that analyses the samples will be masked. Due to the nature of the study, it is not possible to mask the participants or the care providers/investigators.
Primary Purpose: Other
Official 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
Estimated Study Start Date : December 2018
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
Drug Information available for: Insulin

Arm Intervention/treatment
Active Comparator: traditional diabetes diet
Participants in this arm will follow a diet with carbohydrate intake 50-60% of total energy intake
Behavioral: traditional diabetes diet
Diet with carbohydrate content 50-60% of total energy intake

Experimental: moderately low carbohydrate diet
Participants in this arm will follow a diet with carbohydrate intake 30-40% of total energy intake
Behavioral: moderately low carbohydrate diet
Diet with carbohydrate content 30-40% of total energy intake

Experimental: strictly low carbohydrate diet
Participants in this arm will follow a diet with carbohydrate intake 15-20% of total energy intake
Behavioral: strictly low carbohydrate diet
Diet with carbohydrate content 15-20% of total energy intake




Primary Outcome Measures :
  1. Change in insulin use [ Time Frame: screening, day 0, 3 weeks, 6 weeks, 9 weeks, 3 months, 4 months, 5 months, 6 months, 9 months, 12 months ]
    measured in international units (IU) and percentage.


Secondary Outcome Measures :
  1. Change in HbA1c [ Time Frame: screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months ]
    mmol/mol

  2. Concentration of total cholesterol [ Time Frame: screening, 3 months, 6 months, 9 months, 12 months ]
    mmol/L

  3. Concentration of triglycerides [ Time Frame: screening, 3 months, 6 months, 9 months, 12 months ]
    mmol/L

  4. Concentration of HDL-cholesterol [ Time Frame: screening, 3 months, 6 months, 9 months, 12 months ]
    mmol/L

  5. 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. Measurement of glycemic variability [ Time Frame: screening, 3 months, 6 months, 9 months, 12 months ]
    mmol/L

  9. Measurement of weight [ Time Frame: screening, 3 months, 6 months, 9 months, 12 months ]
    kg

  10. BMI [ Time Frame: screening, 3 months, 6 months, 9 months, 12 months ]
    kg/m^2

  11. Measurement of abdominal circumference [ Time Frame: screening, 3 months, 6 months, 9 months, 12 months ]
    cm

  12. Concentration of p-creatinine [ Time Frame: screening, 3 months, 6 months, 9 months, 12 months ]
    micromol/L

  13. estimated Glomerular Filtration Rate (eGFR) [ Time Frame: screening, 3 months, 6 months, 9 months, 12 months ]
    mL/min/1,73 m2

  14. 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 ]

Other Outcome Measures:
  1. Carbohydrate intake [ Time Frame: screening, day 0, 3 weeks, 6 weeks, 9 weeks, 3 months, 4 months, 5 months, 6 months, 7 months, 8 months, 9 months, 10 months, 11 months, 12 months ]
    in grams/day

  2. Carbohydrate intake [ Time Frame: screening, day 0, 3 weeks, 6 weeks, 9 weeks, 3 months, 4 months, 5 months, 6 months, 7 months, 8 months, 9 months, 10 months, 11 months, 12 months ]
    % of total energy intake

  3. Daily energy intake of participants [ Time Frame: screening, day 0, 3 weeks, 6 weeks, 9 weeks, 3 months, 4 months, 5 months, 6 months, 7 months, 8 months, 9 months, 10 months, 11 months, 12 months ]
    kcal/day

  4. Score from the Short Form 36 (SF-36) questionnaire [ Time Frame: screening, 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.

  5. Score from the Well-being Questionnaire-12 (WBQ-12) [ Time Frame: screening, 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.

  6. Score from the Diabetes Treatment Satisfaction Questionnaire (DTSQ) [ Time Frame: screening, 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.

  7. Time taken to complete the Trail making test A+B [ Time Frame: screening, 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.

  8. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • To have had type 1 diabetes for at least 3 years
  • HbA1c ≥ 55 mmol/mol
  • Age 20-70 years old

Exclusion Criteria:

  • Self-reported cardiovascular disease
  • Kidney disease ≥ stadium 3
  • Liver disease, alanine aminotransferase (ALAT) ≥ 2 µkat/L,
  • BMI < 18.5 kg/m^2
  • c-peptide ≥ 0.4 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03761186


Contacts
Contact: Anneli Björklund, MD, PhD 070 5269791 ext +46 anneli.bjorklund@ki.se
Contact: Afroditi Barouti, MSc 0812367162 ext +46 afroditi.barouti@ki.se

Sponsors and Collaborators
Anneli Björklund
Uppsala University Hospital
Investigators
Principal Investigator: Anneli Björklund, MD, PhD Department of Endocrinology at Karolinska University Hospital and Academic Specialistcentrum

Responsible Party: Anneli Björklund, Principal Investigator, Senior Consultant, Associate Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT03761186     History of Changes
Other Study ID Numbers: 2018/218-31
First Posted: December 3, 2018    Key Record Dates
Last Update Posted: December 3, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Anneli Björklund, Karolinska Institutet:
type 1 diabetes
low carbohydrate diet
randomized trial
adults
insulin
metabolic control

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs