- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01184703
Low Glycemic Index Diet in Patients With Type 1 Diabetes (LGID1)
Effects of a Low Glycemic Index Diet on HbA1c and Lipids in Patients With Type I Diabetes
Studieoversigt
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 3
Kontakter og lokationer
Studiesteder
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-
-
Gentofte, Danmark, DK-2820
- Steno Diabetes Center
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
HbA1c
Tidsramme: 3 måneder
|
3 måneder
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
LDL-cholesterol
Tidsramme: 3 months
|
3 months
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Margareta Bensow Bacos, Ch Diet, Steno Diabetes Center Copenhagen
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- GI-project_1
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