Obesity Clinical Trial
— LeguANOfficial title:
Comparison of a High-protein, Carbohydrate-restricted Diet With a High Proportion of Leguminous Protein Compared to Animal Protein on Metabolic Control in Patients With Type 2 Diabetes, "LeguAN Study"
Verified date | April 2015 |
Source | German Institute of Human Nutrition |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Ethics Commission |
Study type | Interventional |
This 6-week parallel randomised prospective dietary intervention study with type 2 Diabetes investigates the nutrition influence of animal protein in comparison to plant protein on the glucose metabolism.
Status | Completed |
Enrollment | 44 |
Est. completion date | March 2015 |
Est. primary completion date | March 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Diabetes mellitus, type 2 - HbA1c between 6-11% Exclusion Criteria: - Consumptive or high grade diseases - Intake of metabolic influence a/o anticoagulent drugs (e.g. cortisone, ASS, antibiotics) - Diabetes type 1 - Pregnancy - Chronic disease of heart, kidney, liver - High grade anaemia - High grade infection disease - Relevant change of body weight (+/- 5 kg) since 8 weeks before begin of study Intervention - Missing data about primary outcome measures (hyperinsulinaemic euglycaemic clamp, mealtime test, data about dietary intake from food diaries or food protocols) - Significant deviation from dietary targets during the monitored 6 weeks isoenergetic period - Allergies including food allergies |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
Germany | German Institute of Human Nutrition | Potsdam-Rehbruecke | Nuthetal |
Lead Sponsor | Collaborator |
---|---|
German Institute of Human Nutrition | Institute of Gain Processing IGV GmbH, Potsdam, Klinikum Ernst von Bergmann Augenklinik Laserzentrum, Ministry of Food and Agriculture, Germany, University Hospital Tuebingen |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Variance of glucose metabolism after different diet intervention | Change of insulin sensitivity measured by hyperinsulinaemic euglycaemic clamp and meal time test (MTT) | week 0 and 6 | No |
Secondary | Development of indices for the prediction of liver fat mass | Change of fat fraction in liver, abdominal and in the total body fat measuring by MRI/H1-spectroscopy | week 0 and 6 | No |
Secondary | Development of indices for the prediction of body fat mass | Change of body fat measuring by body composition assessment (BODPOD) and bioelectrical impedance analysis (BIA) | week 0, 2, 4 and 6 | No |
Secondary | Expression Change of inflammatory markers in blood and fat tissue | Measurement of gene expression of inflammation cytokines | week 0 and 6 | No |
Secondary | Modification of epigenetic DNA | week 0 and 6 | No | |
Secondary | Changes of gastrointestinal microbiota | Molecular mechanisms between nutrition, intestinal bacteria and host | week 0 and 6 | No |
Secondary | Variance of composite biometric data | Change of blood pressure, weight, body mass index, waist-hip ratio | week 0, 2, 4 and 6 | No |
Secondary | Variance of blood data | Changes in the levels of composite circulating inflammatory and metabolic syndrome biomarkers | week 0, 2, 4 and 6 | No |
Secondary | Variance of intestinal hormones | Change of intestinal hormones measured with a meal time test (MTT) | week o and 6 | No |
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