Clinical trial NCT03761186: Comparison of Low, Moderate and High Carbohydrate Diet on Insulin Requirements and Metabolic Control in Type 1 Diabetes
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Type1diabetes
Keywords: type 1 diabetes
low carbohydrate diet
randomized trial
adults
insulin
metabolic control
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Uppsala University Hospital
First posted: 2018-12-03
Enrollment: 103
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in insulin use
timeFrame: screening, day 0, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months
Secondary outcomes:
measure: Change in HbA1c
timeFrame: screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months
measure: Change in concentration of total cholesterol
timeFrame: screening, 3 months, 6 months, 9 months, 12 months
measure: Change in concentration of triglycerides
timeFrame: screening, 3 months, 6 months, 9 months, 12 months
measure: Change in concentration of HDL-cholesterol
timeFrame: screening, 3 months, 6 months, 9 months, 12 months
measure: Change in concentration of LDL-cholesterol
timeFrame: screening, 3 months, 6 months, 9 months, 12 months
measure: Ratio of LDL/HDL
timeFrame: screening, 3 months, 6 months, 9 months, 12 months
measure: Concentration of glucagon
timeFrame: screening, 3 months, 6 months, 9 months, 12 months
measure: Change in markers of glycemic variability (TIR, TAR, TBR, mean sensor glucose with SD, CV)
timeFrame: screening, 3 months, 6 months, 9 months, 12 months
measure: Change in weight
timeFrame: screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months
measure: Change in BMI
timeFrame: screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months
measure: Change in abdominal circumference
timeFrame: screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months
measure: Change in concentration of p-creatinine
timeFrame: screening, 3 months, 6 months, 9 months, 12 months
measure: Change in estimated Glomerular Filtration Rate (eGFR)
timeFrame: screening, 3 months, 6 months, 9 months, 12 months
measure: Change in microalbuminuria
timeFrame: screening, 3 months, 6 months, 9 months, 12 months
measure: Concentration of Insulin-like Growth Factor 1 (IGF-I)
timeFrame: screening, 3 months, 6 months, 9 months, 12 months
measure: Concentration of Insulin-like Growth Factor - binding protein 1 (IGFBP-1)
timeFrame: screening, 3 months, 6 months, 9 months, 12 months
measure: Concentration of leptin
timeFrame: screening, 3 months, 6 months, 9 months, 12 months
measure: Concentration of adiponectin
timeFrame: screening, 3 months, 6 months, 9 months, 12 months
measure: Concentration of interleukin 6 (IL-6)
timeFrame: screening, 3 months, 6 months, 9 months, 12 months
measure: Concentration of high sensitivity c-Reactive Protein (Hs-CRP)
timeFrame: screening, 3 months, 6 months, 9 months, 12 months
measure: Measurement of lipopolysaccharides (LPS) activity using the Limulus Amebocyte Lysate (LAL) assay
timeFrame: screening, 3 months, 6 months, 9 months, 12 months
measure: Concentration of glutaredoxin 1 (GRX-1)
timeFrame: screening, 3 months, 6 months, 9 months, 12 months
measure: Concentration of Oxidized LDL
timeFrame: screening, 3 months, 6 months, 9 months, 12 months
measure: Total Antioxidant Capacity (TAC)
timeFrame: screening, 3 months, 6 months, 9 months, 12 months
measure: Concentration of reactive oxygen species (ROS)
timeFrame: screening, 3 months, 6 months, 9 months, 12 months
measure: Plasma metabolites assessed by untargeted liquid chromatography - mass spectrometry (LC-MS) metabolomics
timeFrame: screening, 3 months, 6 months, 9 months, 12 months
measure: Score from the Short Form 36 (SF-36) questionnaire
timeFrame: screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months
measure: Score from the Well-being Questionnaire-12 (WBQ-12)
timeFrame: screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months
measure: Score from the Diabetes Treatment Satisfaction Questionnaire (DTSQ)
timeFrame: screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months
measure: Time taken to complete the Trail making test A+B
timeFrame: screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months
Other outcomes:
measure: Carbohydrate intake
timeFrame: screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months
measure: Energy intake from carbohydrates
timeFrame: screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months
measure: Daily energy intake of participants
timeFrame: screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months
measure: Frequency of intake of different foods measured by a Food frequency questionnaire (FFQ)
timeFrame: screening, 6 months,12 months
Locations:
city: Stockholm
country: Sweden
facility: Center for Diabetes, Academic Specialistcenter
Study officials:
affiliation: Department of Endocrinology at Karolinska University Hospital and Academic Specialistcentrum
name: Anneli Björklund, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: