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

Short Term Diet Intervention in Newly Diagnosed Type 2 Diabetes. a Randomised, Multicentric, Controlled, Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Dietary supplement: diet intervention

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

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lejla Zahiragic, MD; Phone Number: 319 00492118104819; Email: lejla.zahiragic@med.uni-duesseldorf.de
• Study Contact Backup: Name: Bettina Nowotny, MD, M.Sc.; Phone Number: 00492113382575; Email: studienzentrum@ddz.uni-duesseldorf.de

Study Locations

• Germany
  • Berlin, Germany
    • Charite, Department of Internal Medicine
  • Dresden, Germany
    • University Hospital, Department of Internal Medicine III
  • Heidelberg, Germany
    • University Hospital, Department of Internal Medicine I
  • Munich, Germany
    • Klinikum der Universität München (KUM)
  • Tübingen, Germany
    • University Hospital, Department of Internal Medicine IV
  • NRW
    • Duesseldorf, NRW, Germany, 40225
      • German Diabetes Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Dietary supplement: diet intervention; 8-week diet lacking red meat, but containing increased fibers and coffee (verum) versus standard recommendation (control) eating red meat.
Active Comparator: 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.	Dietary supplement: diet intervention; 8-week diet lacking red meat, but containing increased fibers and coffee (verum) versus standard recommendation (control) eating red meat.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
whole body insulin sensitivity	measurement of whole body insulin sensitivity with hyperinsulinamic euglicamic clamp	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
total body fat	MRI measurement of the effects of 8-week diet intervention on total body fat	8 weeks
intramyocellular lipids	MRS measurement to investigate the effects of diet intervention on ectopic lipid content in skeletal muscle	8 weeks
hepatocellular lipids	MRS measurement to investigate the effects of diet intervention on ectopic lipid content in liver(HCL)	8 weeks
insulin secretion	measurement of insulin secretion with glucagon test, mixed-meal test and intravenous glucose tolerance test	8 weeks
pancreatic fat	MRI measurement of the effects of 8-week diet intervention on pancreatic fat	8 weeks
skeletal muscle mitochondrial function - insulin signaling	muscle biopsy for assessment of insulin signaling	8 weeks
skeletal muscle mitochondrial function - phosphate-recovery time	skeletal muscle mitochondrial function in vivo assessed as phosphate-recovery time with MRS	8 weeks

Collaborators and Investigators

• Sponsor: German Diabetes Center
• Investigators: Study Director: Michael Roden, MD, German Diabetes Center

Publications and helpful links

General Publications

• 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.
• 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.
• 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. Erratum In: Diabetologia. 2016 Jun;59(6):1329.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2011
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: June 8, 2011
• First Submitted That Met QC Criteria: August 3, 2011
• First Posted (Estimated): August 4, 2011

Study Record Updates

• Last Update Posted (Actual): June 5, 2023
• Last Update Submitted That Met QC Criteria: June 2, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: insulin sensitivity; type 2 diabetes; diet intervention
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: DDIET3521