German Diabetes-Diet-Intervention and Energy Restriction-Trial (DDIET)
- Conditions
- Type 2 Diabetes
- Interventions
- Dietary Supplement: diet intervention
- Registration Number
- NCT01409330
- Lead Sponsor
- German Diabetes Center
- Brief Summary
Diet intervention according to the German Diabetes Risk Score in newly diagnosed type 2 diabetes.
This study aims to explore the effect of diet lacking red meat, but containing increased fibers and coffee (verum) versus standard recommendation (control) in a multicenter setting.
- Detailed Description
This study is a randomised, multicenter controlled trial Our Aim is to test the effects of an 8-week diet lacking red meat, containing increased fibers and coffee (verum) versus standard recommendation (control)in a multicenter setting.
We are expecting that the verum diet will improve insulin sensitivity and insulin secretion due to reductions in visceral and hepatic fat along with improved adipocyte cytokine secretion profiles
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- Type 2 diabetic patients
- disease duration for five years or less,
- age of 69 years or less,
- body mass index of 30 kg/m2 or more,
- hemoglobin A1c of 5,5 % to 9%
- patient should be on standard diet or metformin +/- acarbose monotherapy
- patient should be without exclusion criteria for coffee consumption
- disease duration more than five years,
- age of > 69 years,
- body mass index of < 30 kg/m2,
- hemoglobin A1c < 5,5 % or > 9%
- if patient becomes insulin therapy
- if patient has exclusion criteria for coffee consumption
- if patient is non-compliant with study protocol
- if patient is pregnant
- if patient has acute infection
- if patient has anaemia
- if patient has malignancies
- if patient has autoimmune or immune compromising diseases including HIV/AIDS
- if patient has psychiatric diseases or addiction
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description hypocaloric diet containing increased fibers and coffee diet intervention In the intervention group the patients are allowed to eat only white meat and fish. They also need to increase their daily fiber intake to 50grams and drink 5 cups of coffee a day. hypocaloric diet containing red meat diet intervention control group (n=20): diet according to the ADA/EASD guidelines (50% carbohydrates, 20% proteins, 30% fat). In the control group the patients should eat 150 grams of red meat a day and are not allowed to consume alcohol, coffee and whole grains.
- Primary Outcome Measures
Name Time Method whole body insulin sensitivity 8 weeks measurement of whole body insulin sensitivity with hyperinsulinamic euglicamic clamp
- Secondary Outcome Measures
Name Time Method intramyocellular lipids 8 weeks MRS measurement to investigate the effects of diet intervention on ectopic lipid content in skeletal muscle
skeletal muscle mitochondrial function - phosphate-recovery time 8 weeks skeletal muscle mitochondrial function in vivo assessed as phosphate-recovery time with MRS
hepatocellular lipids 8 weeks MRS measurement to investigate the effects of diet intervention on ectopic lipid content in liver(HCL)
insulin secretion 8 weeks measurement of insulin secretion with glucagon test, mixed-meal test and intravenous glucose tolerance test
total body fat 8 weeks MRI measurement of the effects of 8-week diet intervention on total body fat
skeletal muscle mitochondrial function - insulin signaling 8 weeks muscle biopsy for assessment of insulin signaling
pancreatic fat 8 weeks MRI measurement of the effects of 8-week diet intervention on pancreatic fat
Trial Locations
- Locations (6)
German Diabetes Center
🇩🇪Duesseldorf, NRW, Germany
Charite, Department of Internal Medicine
🇩🇪Berlin, Germany
University Hospital, Department of Internal Medicine I
🇩🇪Heidelberg, Germany
University Hospital, Department of Internal Medicine III
🇩🇪Dresden, Germany
University Hospital, Department of Internal Medicine IV
🇩🇪Tübingen, Germany
Klinikum der Universität München (KUM)
🇩🇪Munich, Germany