Status:
COMPLETED
German Diabetes-Diet-Intervention and Energy Restriction-Trial (DDIET)
Lead Sponsor:
German Diabetes Center
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-69 years
Phase:
NA
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 c...
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 recommendatio...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01409330
Start Date
February 1 2011
End Date
December 1 2013
Last Update
June 5 2023
Active Locations (6)
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1
German Diabetes Center
Düsseldorf, North Rhine-Westphalia, Germany, 40225
2
Charite, Department of Internal Medicine
Berlin, Germany
3
University Hospital, Department of Internal Medicine III
Dresden, Germany
4
University Hospital, Department of Internal Medicine I
Heidelberg, Germany