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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2013-12-31

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.

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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

Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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hypocaloric diet containing increased fibers and coffee

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.

Group Type EXPERIMENTAL

diet intervention

Intervention Type DIETARY_SUPPLEMENT

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

hypocaloric diet containing red meat

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.

Group Type ACTIVE_COMPARATOR

diet intervention

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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diet intervention

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

Intervention Type DIETARY_SUPPLEMENT

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

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 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No