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

NCT01409330 | Completed

• 1 other identifier: DDIET3521
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 6

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.

Conditions

Type 2 Diabetes

Keywords

insulin sensitivity; type 2 diabetes; diet intervention

Outcome Measures

Primary Outcomes (1)

• whole body insulin sensitivity

  measurement of whole body insulin sensitivity with hyperinsulinamic euglicamic clamp

  8 weeks

Secondary Outcomes (7)

• total body fat

  8 weeks

• intramyocellular lipids

  8 weeks

• skeletal muscle mitochondrial function - insulin signaling

  8 weeks

• hepatocellular lipids

  8 weeks

• skeletal muscle mitochondrial function - phosphate-recovery time

  8 weeks

Study Arms (2)

hypocaloric diet containing increased fibers and coffee

EXPERIMENTAL

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.

Dietary Supplement: diet intervention

hypocaloric diet containing red meat

ACTIVE COMPARATOR

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.

Dietary Supplement: diet intervention

Interventions

diet intervention 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 increased fibers and coffee; hypocaloric diet containing red meat

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• German Diabetes Center: lead

Study Sites (6)

German Diabetes Center

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Location

Charite, Department of Internal Medicine

Berlin, Germany

Location

University Hospital, Department of Internal Medicine III

Dresden, Germany

Location

University Hospital, Department of Internal Medicine I

Heidelberg, Germany

Location

Klinikum der Universität München (KUM)

Munich, Germany

Location

University Hospital, Department of Internal Medicine IV

Tübingen, Germany

Location

Related Publications (4)

• Pafili K, Zaharia OP, Strassburger K, Knebel B, Herder C, Huttasch M, Karusheva Y, Kabisch S, Strom A, Nowotny B, Szendroedi J, Roden M. PNPLA3 gene variation modulates diet-induced improvement in liver lipid content in type 2 diabetes. Clin Nutr. 2025 May;48:6-15. doi: 10.1016/j.clnu.2025.02.032. Epub 2025 Mar 6.

  PMID: 40090039 DERIVED

• 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.

  PMID: 30619502 DERIVED

• 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.

  PMID: 26070589 DERIVED

• 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.

  PMID: 25425219 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Insulin Resistance

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Study Officials

• Michael Roden, MD

  German Diabetes Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2011
• First Posted: August 4, 2011
• Study Start: February 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: December 1, 2013
• Last Updated: June 5, 2023

Record last verified: 2023-06

Locations

DE (6)