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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01184703
First Posted: August 19, 2010
Last Update Posted: September 6, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Steno Diabetes Center
  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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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:


Further study details as provided by Steno Diabetes Center:

Primary Outcome Measures:
  • HbA1c [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • LDL-cholesterol [ Time Frame: 3 months ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Margareta Bensow Bacos, Steno Diabetes Center
ClinicalTrials.gov Identifier: NCT01184703     History of Changes
Other Study ID Numbers: GI-project_1
First Submitted: August 17, 2010
First Posted: August 19, 2010
Last Update Posted: September 6, 2010
Last Verified: August 2010

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