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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 1
 Other: Low GI food
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Effects of a Low Glycemic Index Diet on HbA1c and Lipids in Patients With Type I Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Steno Diabetes Center:

Primary Outcome Measures:
  • HbA1c [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • LDL-cholesterol [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 65
Study Start Date: June 2007
Study Completion Date: December 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Low GI food
    Comparison of carbohydrates in diabetic patients
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 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.

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01184703

Locations
Denmark
Steno Diabetes Center
Gentofte, Denmark, DK-2820
Sponsors and Collaborators
Steno Diabetes Center
Investigators
Principal Investigator: Margareta Bensow Bacos, Ch Diet Steno Diabetes Center
  More Information

No publications provided

Responsible Party: Margareta Bensow Bacos, Steno Diabetes Center
ClinicalTrials.gov Identifier: NCT01184703     History of Changes
Other Study ID Numbers: GI-project_1
Study First Received: August 17, 2010
Last Updated: September 2, 2010
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Steno Diabetes Center:
Diabetes Mellitus, Type 1
Glycemic Index Diet
HbA1c
Lipids

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on June 17, 2013