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Completed

NCT Number: NCT01184703

Low Glycemic Index Diet in Patients With Type 1 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.

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Key information

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Steno Diabetes Center

Gentofte Municipality, DK-2820, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Low GI food

Other

Comparison of carbohydrates in diabetic patients

Primary outcomes

  1. HbA1c

    Time frame: 3 months

Secondary outcomes

  1. LDL-cholesterol

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Steno Diabetes Center Copenhagen

Other

Registry information

Official study title

Effects of a Low Glycemic Index Diet on HbA1c and Lipids in Patients With Type I Diabetes

Acronym: LGID1

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Aug 19, 2010
Registry last updated
Sep 6, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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