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

September 2, 2010 updated by: Steno Diabetes Center Copenhagen

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

65

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Gentofte, Denmark, DK-2820
        • Steno Diabetes center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HbA1c
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
LDL-cholesterol
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Steno Diabetes Center Copenhagen

Investigators

  • Principal Investigator: Margareta Bensow Bacos, Ch Diet, Steno Diabetes Center Copenhagen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

August 17, 2010

First Submitted That Met QC Criteria

August 18, 2010

First Posted (Estimate)

August 19, 2010

Study Record Updates

Last Update Posted (Estimate)

September 6, 2010

Last Update Submitted That Met QC Criteria

September 2, 2010

Last Verified

August 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GI-project_1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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