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

German Diabetes Center

Status: Completed

Conditions: Type 2 Diabetes

Treatments: Dietary Supplement: diet intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT01409330

DDIET3521

Details and patient eligibility

About

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.

Full 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

Enrollment: 40 patients

Sex: All

Ages: 18 to 69 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

40 participants in 2 patient groups

hypocaloric diet containing increased fibers and coffee

Experimental group

Description:

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.

Treatment:

Dietary Supplement: diet intervention

hypocaloric diet containing red meat

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: diet intervention