Status:
COMPLETED
Low Glycemic Index Diet in Patients With Type 1 Diabetes
Lead Sponsor:
Steno Diabetes Center Copenhagen
Conditions:
Diabetes Mellitus, Type 1
Eligibility:
All Genders
20-65 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to investigate if a low glycemic index diet in comparison with a medium/high glycemic index diet improves the metabolic control in patients with type 1 diabetes.
Detailed Description
The glycemic index (GI) was introduced by Jenkins and co-workers in the early 1980s, and is a concept for ranking of carbohydrate foods based on their effect on postprandial glycaemia. A meta-analysis...
Eligibility Criteria
Inclusion
- Type I diabetes, durability \>5 years
- Age 20-65 years
- Normal weight (BMI 19-26 kg/m2)
- Diabetic treatment with mealtime and bedtime insulin.
- HbA1c ≤10 %
- Informed consent to participate in the study.
Exclusion
- Diabetic complications; neuropathy, foot ulcers and/or gastroparesis.
- A known food intolerance of gluten, leguminous plants, nuts or almonds.
- Pregnancy or breast-feeding.
- Concurrent participation in another research study with metabolic effects.
- Previously regular follow-up with a dietician at SDC during the last year.
- Adjustment during the study of medical treatment other than insulin and/or nutritional supplement with metabolic effects.
- Non acceptance of the study diet or food products that are recommended in the study.
- Disability to read and understand the Danish language.
- Unable to receive and/or store the test products.
- Place of residence \>1 hr drive from SDC.
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT01184703
Start Date
June 1 2007
End Date
December 1 2009
Last Update
September 6 2010
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Steno Diabetes Center
Gentofte Municipality, Denmark, DK-2820