Low Glycemic Index Diet in Patients With Type 1 Diabetes (LGID1)

This study has been completed.
Sponsor:
Information provided by:
Steno Diabetes Center
ClinicalTrials.gov Identifier:
NCT01184703
First received: August 17, 2010
Last updated: September 2, 2010
Last verified: August 2010

August 17, 2010
September 2, 2010
June 2007
August 2009   (final data collection date for primary outcome measure)
HbA1c [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01184703 on ClinicalTrials.gov Archive Site
LDL-cholesterol [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Low Glycemic Index Diet in Patients With Type 1 Diabetes
Effects of a Low Glycemic Index Diet on HbA1c and Lipids in Patients With Type I Diabetes

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.

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 of randomised controlled trials of the effect of low GI diets in the management of diabetes showed a beneficial effect (i.e., a reduction in HbA1c) of low GI versus high GI foods. However, several critical points concerning the GI concept remain, for instance, how to apply it in practical every day life, how to calculate GI in mixed meals, how to find relevant low GI foods, how to ensure compliance to a low GI diet. The most important issue, however, is the fact that studies on the long-term effects of a low GI diet in type 1 diabetes are lacking. In this study, the critical issue of finding palatable low GI foods will be solved in close collaboration with the food industry. This may lead to the development of new commercial products with low GI, which is necessary if low GI diets are to be advocated for diabetics in the future.

Comparison(s): A low glycemic index diet, compared to a medium/normal glycemic index diet.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Diabetes Mellitus, Type 1
Other: Low GI food
Comparison of carbohydrates in diabetic patients
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
65
December 2009
August 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 Criteria:

  • 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.
Both
20 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01184703
GI-project_1
No
Margareta Bensow Bacos, Steno Diabetes Center
Steno Diabetes Center
Not Provided
Principal Investigator: Margareta Bensow Bacos, Ch Diet Steno Diabetes Center
Steno Diabetes Center
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP