Carbohydrate Content in the Diet in Type 1 Diabetes
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Moderate carbohydrate diet A healthy diet containing 30 E % carbohydrates |
Other: Moderate carbohydrate diet
30 E % carbohydrates included in the diet
|
| Experimental: Higher carbohydrate diet A healthy diet containing 50 E % carbohydrates |
Other: Higher carbohydrate diet
50 E % carbohydrates included in the diet
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
- 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
- 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
- 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
- LDL cholesterol [Week 4, week 12]
The difference in LDL cholesterol between week 4 and week 12
- HDL cholesterol [Week 4, week 12]
The difference in HDL cholesterol between week 4 and week 12
- Triglycerides [Week 4, week 12]
The difference in triglycerides between week 4 and week 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
- Diabetes Treatment Satisfaction Questionnaire (DTSQs) score [Week 4, week 12]
The difference in DTSQs scores 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
Other Outcome Measures
- The difference in Mean Amplitude of Glycemic Excursions (MAGE) [Week 3-4, week 11-12]
Measured by continuous glucose monitoring (CGM) between week 3-4 and week 11-12
- HbA1c [Week 4, week 12]
The difference in HbA1c between week 4 and week 12
- Apolipoproteins [Week 4, week 12]
The difference in apolipoproteins between week 4 and week 12
- The difference in the proportion of time with low glucose levels [Week 3-4, week 11-12]
Measured by continuous glucose monitoring (CGM) between week 3-4 and week 11-12
- Ketones [Week 1-4, week 9-12]
The difference in ketone levels between week 1-4 and week 9-12
- Ketoacidosis [Week 1-4, week 9-12]
Occurence of ketoacidosis during the study period and differences between week 1-4 and week 9-12
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Type 1 diabetes
-
Adults 18 years or older
-
Written Informed Consent
-
HbA1c ≥ 58 mmol/mol (7,5 % DCCT standard)
Exclusion Criteria:
-
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | NU Hospital Organization | Uddevalla | Sweden | 45180 |
Sponsors and Collaborators
- Vastra Gotaland Region
Investigators
- Principal Investigator: Marcus Lind, PhD, NU Hospital Organization/University of Gothenburg
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Carbohydrate study