Clinical trial NCT01409330: German Diabetes-Diet-Intervention and Energy Restriction-Trial (DDIET)
Official title: Short Term Diet Intervention in Newly Diagnosed Type 2 Diabetes. a Randomised, Multicentric, Controlled, Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: insulin sensitivity
type 2 diabetes
diet intervention
Lead sponsor: German Diabetes Center
Sponsor class: OTHER
First posted: 2011-08-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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 coffee (verum) versus standard recommendation (control) in a multicenter setting.

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 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

Eligibility criteria: 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

Primary outcomes:
measure: whole body insulin sensitivity
timeFrame: 8 weeks
Secondary outcomes:
measure: total body fat
timeFrame: 8 weeks
measure: intramyocellular lipids
timeFrame: 8 weeks
measure: skeletal muscle mitochondrial function - insulin signaling
timeFrame: 8 weeks
measure: hepatocellular lipids
timeFrame: 8 weeks
measure: skeletal muscle mitochondrial function - phosphate-recovery time
timeFrame: 8 weeks
measure: insulin secretion
timeFrame: 8 weeks
measure: pancreatic fat
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Duesseldorf
country: Germany
facility: German Diabetes Center
state: NRW
city: Berlin
country: Germany
facility: Charite, Department of Internal Medicine
city: Dresden
country: Germany
facility: University Hospital, Department of Internal Medicine III
city: Heidelberg
country: Germany
facility: University Hospital, Department of Internal Medicine I
city: Munich
country: Germany
facility: Klinikum der Universität München (KUM)
city: Tübingen
country: Germany
facility: University Hospital, Department of Internal Medicine IV
Study officials:
affiliation: German Diabetes Center
name: Michael Roden, MD
role: STUDY_DIRECTOR
References:
citation: Karusheva Y, Kunstein L, Bierwagen A, Nowotny B, Kabisch S, Groener JB, Fleitmann AK, Herder C, Pacini G, Strassburger K, Haring HU, Nawroth PP, Pfeiffer AFH, Burkart V, Mussig K, Roden M, Szendroedi J. An 8-week diet high in cereal fiber and coffee but free of red meat does not improve beta-cell function in patients with type 2 diabetes mellitus: a randomized controlled trial. Nutr Metab (Lond). 2018 Dec 29;15:90. doi: 10.1186/s12986-018-0324-5. eCollection 2018.
citation: Ziegler D, Strom A, Nowotny B, Zahiragic L, Nowotny PJ, Carstensen-Kirberg M, Herder C, Roden M. Effect of Low-Energy Diets Differing in Fiber, Red Meat, and Coffee Intake on Cardiac Autonomic Function in Obese Individuals With Type 2 Diabetes. Diabetes Care. 2015 Sep;38(9):1750-7. doi: 10.2337/dc15-0466. Epub 2015 Jun 12.
citation: Nowotny B, Zahiragic L, Bierwagen A, Kabisch S, Groener JB, Nowotny PJ, Fleitmann AK, Herder C, Pacini G, Erlund I, Landberg R, Haering HU, Pfeiffer AF, Nawroth PP, Roden M. Low-energy diets differing in fibre, red meat and coffee intake equally improve insulin sensitivity in type 2 diabetes: a randomised feasibility trial. Diabetologia. 2015 Feb;58(2):255-64. doi: 10.1007/s00125-014-3457-8. Epub 2014 Nov 26.