Carbohydrate Content in the Diet in Type 1 Diabetes
- Conditions
- Diabetes Mellitus, Type 1
- Interventions
- Other: Moderate carbohydrate dietOther: Higher carbohydrate diet
- Registration Number
- NCT03400618
- Lead Sponsor
- Vastra Gotaland Region
- Brief Summary
The aim of this study is to analyse the effect of a diet with a moderate amount of carbohydrates and compare it with a traditional diabetic diet with a higher content of carbohydrates on mean glucose level, high and low glucose levels, and the risk of ketoacidosis in patients with type 1 diabetes. The glucose levels will be measured by blinded continuous glucose monitoring (CGM).
The trial has a cross-over design and 12 weeks in duration, where patients will be randomized to; 1) a diet with moderate carbohydrate content for 4 weeks and 2) a traditional diabetes diet for 4 weeks and with a wash-out period between for 4 weeks. The two diets will both be healthy and planned by a dietitian. There will be 50 subjects included in the study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 54
- Type 1 diabetes
- Adults 18 years or older
- Written Informed Consent
- HbA1c ≥ 58 mmol/mol (7,5 % DCCT standard)
- Pregnancy or planned pregnancy for the study duration
- Severe cognitive dysfunction or other disease, which is judged by the physician to be not suitable for inclusion
- Problems with compliance to the intervention diets (excluding a lot of the foods that are common in the diets like wholegrain/beans/lentils/fruit/vegetables) because of personal preferences, other diseases, stomach problems etc.
- Diabetes duration < 1 year
- Planned change in diabetes treatment (eg. Start with insulin pump, CGM etc.) during the study period
- Other investigator-determined criteria unsuitable for patient participation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Moderate carbohydrate diet Moderate carbohydrate diet A healthy diet containing 30 E % carbohydrates Higher carbohydrate diet Higher carbohydrate diet A healthy diet containing 50 E % carbohydrates
- Primary Outcome Measures
Name Time Method The difference in mean glucose level Week 3-4, week 11-12 Measured by continuous glucose monitoring (CGM) between week 3-4 and week 11-12
- Secondary Outcome Measures
Name Time Method LDL cholesterol Week 4, week 12 The difference in LDL cholesterol between week 4 and week 12
The difference in standard deviation of glucose levels Week 3-4, week 11-12 Measured by continuous glucose monitoring (CGM) between week 3-4 and week 11-12
Total insulin dose Week 1-4, week 9-12 The difference in total insulin dose between week 1-4 and week 9-12
Diabetes Treatment Satisfaction Questionnaire (DTSQc) score Week 12 The difference in DTSQc score at week 12
The difference in the proportion of time with euglycaemic levels Week 3-4, week 11-12 Measured by continuous glucose monitoring (CGM) between week 3-4 and week 11-12
HDL cholesterol Week 4, week 12 The difference in HDL cholesterol between week 4 and week 12
Diabetes Treatment Satisfaction Questionnaire (DTSQs) score Week 4, week 12 The difference in DTSQs scores between week 4 and week 12
The difference in the proportion of time with high glucose levels Week 3-4, week 11-12 Measured by continuous glucose monitoring (CGM) between week 3-4 and week 11-12
Weight Week 4, week 12 The difference in weight between week 4 and week 12
Total cholesterol Week 4, week 12 The difference in total cholesterol between week 4 and week 12
Triglycerides Week 4, week 12 The difference in triglycerides between week 4 and week 12
Hypoglycemia confidence score Week 4, week 12 The difference in hypoglycaemia confidence scores between week 4 and week 12
Trial Locations
- Locations (1)
NU Hospital Organization
🇸🇪Uddevalla, Sweden