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

German Diabetes Center40 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Type 2 Diabetes

Interventions

diet interventionDIETARY_SUPPLEMENT

8-week diet lacking red meat, but containing increased fibers and coffee (verum) versus standard recommendation (control) eating red meat.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 69 Years

Medical Language ↔ Plain English

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

Locations (6)

German Diabetes Center

Düsseldorf, North Rhine-Westphalia, Germany

Charite, Department of Internal Medicine

Berlin, Germany

University Hospital, Department of Internal Medicine III

Dresden, Germany

University Hospital, Department of Internal Medicine I

Heidelberg, Germany

Outcomes

Primary Outcomes

whole body insulin sensitivity

measurement of whole body insulin sensitivity with hyperinsulinamic euglicamic clamp

Time frame: 8 weeks

Secondary Outcomes

total body fat

MRI measurement of the effects of 8-week diet intervention on total body fat

Time frame: 8 weeks

intramyocellular lipids

MRS measurement to investigate the effects of diet intervention on ectopic lipid content in skeletal muscle

Time frame: 8 weeks

skeletal muscle mitochondrial function - insulin signaling

muscle biopsy for assessment of insulin signaling

Time frame: 8 weeks

hepatocellular lipids

MRS measurement to investigate the effects of diet intervention on ectopic lipid content in liver(HCL)

Time frame: 8 weeks

skeletal muscle mitochondrial function - phosphate-recovery time

skeletal muscle mitochondrial function in vivo assessed as phosphate-recovery time with MRS

Time frame: 8 weeks

insulin secretion

measurement of insulin secretion with glucagon test, mixed-meal test and intravenous glucose tolerance test

Time frame: 8 weeks

pancreatic fat

MRI measurement of the effects of 8-week diet intervention on pancreatic fat

Time frame: 8 weeks

Data from ClinicalTrials.gov

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