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

Type1diabetes Clinical Trial

— DANCE  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03761186
• Other study ID #: 2018/218-31
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 12, 2018
• Est. completion date: March 2024

Study information

• Verified date: September 2023
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 103
• Est. completion date: March 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type1diabetes

Intervention

Behavioral:
• traditional diabetes diet
Diet with carbohydrate content 50-60% of total energy intake
• moderately low carbohydrate diet
Diet with carbohydrate content 30-40% of total energy intake
• strictly low carbohydrate diet
Diet with carbohydrate content 15-20% of total energy intake

Locations

Country	Name	City	State
Sweden	Center for Diabetes, Academic Specialistcenter	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Anneli Björklund	Uppsala University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Carbohydrate intake	in grams/day	screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months
Other	Energy intake from carbohydrates	% of total energy intake	screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months
Other	Daily energy intake of participants	kcal/day	screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months
Other	Frequency of intake of different foods measured by a Food frequency questionnaire (FFQ)	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.	screening, 6 months,12 months
Primary	Change in insulin use	measured in international units (IU) and percentage.	screening, day 0, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months
Secondary	Change in HbA1c	mmol/mol	screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months
Secondary	Change in concentration of total cholesterol	mmol/L	screening, 3 months, 6 months, 9 months, 12 months
Secondary	Change in concentration of triglycerides	mmol/L	screening, 3 months, 6 months, 9 months, 12 months
Secondary	Change in concentration of HDL-cholesterol	mmol/L	screening, 3 months, 6 months, 9 months, 12 months
Secondary	Change in concentration of LDL-cholesterol	mmol/L	screening, 3 months, 6 months, 9 months, 12 months
Secondary	Ratio of LDL/HDL	absolute number	screening, 3 months, 6 months, 9 months, 12 months
Secondary	Concentration of glucagon	pmol/L	screening, 3 months, 6 months, 9 months, 12 months
Secondary	Change in markers of glycemic variability (TIR, TAR, TBR, mean sensor glucose with SD, CV)	mmol/L	screening, 3 months, 6 months, 9 months, 12 months
Secondary	Change in weight	kg	screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months
Secondary	Change in BMI	kg/m^2	screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months
Secondary	Change in abdominal circumference	cm	screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months
Secondary	Change in concentration of p-creatinine	micromol/L	screening, 3 months, 6 months, 9 months, 12 months
Secondary	Change in estimated Glomerular Filtration Rate (eGFR)	mL/min/1,73 m2	screening, 3 months, 6 months, 9 months, 12 months
Secondary	Change in microalbuminuria	morning U-Alb/Crea (mg/mmol)	screening, 3 months, 6 months, 9 months, 12 months
Secondary	Concentration of Insulin-like Growth Factor 1 (IGF-I)	microg/L	screening, 3 months, 6 months, 9 months, 12 months
Secondary	Concentration of Insulin-like Growth Factor - binding protein 1 (IGFBP-1)	microg/L	screening, 3 months, 6 months, 9 months, 12 months
Secondary	Concentration of leptin	microg/L	screening, 3 months, 6 months, 9 months, 12 months
Secondary	Concentration of adiponectin	mg/L	screening, 3 months, 6 months, 9 months, 12 months
Secondary	Concentration of interleukin 6 (IL-6)	ng/L	screening, 3 months, 6 months, 9 months, 12 months
Secondary	Concentration of high sensitivity c-Reactive Protein (Hs-CRP)	mg/L	screening, 3 months, 6 months, 9 months, 12 months
Secondary	Measurement of lipopolysaccharides (LPS) activity using the Limulus Amebocyte Lysate (LAL) assay	measured in endotoxin units (EU)/ml	screening, 3 months, 6 months, 9 months, 12 months
Secondary	Concentration of glutaredoxin 1 (GRX-1)		screening, 3 months, 6 months, 9 months, 12 months
Secondary	Concentration of Oxidized LDL		screening, 3 months, 6 months, 9 months, 12 months
Secondary	Total Antioxidant Capacity (TAC)		screening, 3 months, 6 months, 9 months, 12 months
Secondary	Concentration of reactive oxygen species (ROS)		screening, 3 months, 6 months, 9 months, 12 months
Secondary	Plasma metabolites assessed by untargeted liquid chromatography - mass spectrometry (LC-MS) metabolomics		screening, 3 months, 6 months, 9 months, 12 months
Secondary	Score from the Short Form 36 (SF-36) questionnaire	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.	screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months
Secondary	Score from the Well-being Questionnaire-12 (WBQ-12)	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.	screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months
Secondary	Score from the Diabetes Treatment Satisfaction Questionnaire (DTSQ)	The DTSQ has been developed to assess patient satisfaction with diabetes treatment. The questionnaire is composed of two different factors. The ?rst 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 ?rst factor (total score 36), with a higher score indicating higher treatment satisfaction.	screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months
Secondary	Time taken to complete the Trail making test A+B	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.	screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months