German Diabetes-Diet-Intervention and Energy Restriction-Trial (DDIET)

Study Overview
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Brief Summary
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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
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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

Official Title
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Short Term Diet Intervention in Newly Diagnosed Type 2 Diabetes. a Randomised, Multicentric, Controlled, Clinical Trial

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Dietary Supplement: diet intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: hypocaloric diet containing increased fibers and coffee<br>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. | Dietary Supplement: diet intervention<br>* 8-week diet lacking red meat, but containing increased fibers and coffee (verum) versus standard recommendation (control) eating red meat.<br>|
| Active Comparator: hypocaloric diet containing red meat<br>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. | Dietary Supplement: diet intervention<br>* 8-week diet lacking red meat, but containing increased fibers and coffee (verum) versus standard recommendation (control) eating red meat.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| whole body insulin sensitivity | measurement of whole body insulin sensitivity with hyperinsulinamic euglicamic clamp | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total body fat | MRI measurement of the effects of 8-week diet intervention on total body fat | 8 weeks | 
| intramyocellular lipids | MRS measurement to investigate the effects of diet intervention on ectopic lipid content in skeletal muscle | 8 weeks | 
| skeletal muscle mitochondrial function - insulin signaling | muscle biopsy for assessment of insulin signaling | 8 weeks | 
| hepatocellular lipids | MRS measurement to investigate the effects of diet intervention on ectopic lipid content in liver(HCL) | 8 weeks | 
| skeletal muscle mitochondrial function - phosphate-recovery time | skeletal muscle mitochondrial function in vivo assessed as phosphate-recovery time with MRS | 8 weeks | 
| insulin secretion | measurement of insulin secretion with glucagon test, mixed-meal test and intravenous glucose tolerance test | 8 weeks | 
| pancreatic fat | MRI measurement of the effects of 8-week diet intervention on pancreatic fat | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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insulin sensitivity, type 2 diabetes, diet intervention