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

This study is currently recruiting participants.
Verified August 2012 by German Diabetes Center
Sponsor:
Information provided by (Responsible Party):
German Diabetes Center
ClinicalTrials.gov Identifier:
NCT01409330
First received: June 8, 2011
Last updated: August 21, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes
 Dietary Supplement: diet intervention
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Short Term Diet Intervention in Newly Diagnosed Type 2 Diabetes. a Randomised, Multicentric, Controlled, Clinical Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by German Diabetes Center:

Primary Outcome Measures:
  • whole body insulin sensitivity [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    measurement of whole body insulin sensitivity with hyperinsulinamic euglicamic clamp


Secondary Outcome Measures:
  • total body fat [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    MRI measurement of the effects of 8-week diet intervention on total body fat

  • intramyocellular lipids [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    MRS measurement to investigate the effects of diet intervention on ectopic lipid content in skeletal muscle

  • skeletal muscle mitochondrial function [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    muscle biopsy for assessment of insulin signaling

  • hepatocellular lipids [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    MRS measurement to investigate the effects of diet intervention on ectopic lipid content in liver(HCL)

  • skeletal muscle mitochondrial function [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    skeletal muscle mitochondrial function in vivo assessed as phosphate-recovery time with MRS

  • insulin secretion [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    measurement of insulin secretion with glucagon test, mixed-meal test and intravenous glucose tolerance test

  • pancreatic fat [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    MRI measurement of the effects of 8-week diet intervention on pancreatic fat


Estimated Enrollment: 40
Study Start Date: February 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01409330

Contacts
Contact: Lejla Zahiragic, MD 00492118104819 ext 319 lejla.zahiragic@med.uni-duesseldorf.de
Contact: Bettina Nowotny, MD, M.Sc. 00492113382575 studienzentrum@ddz.uni-duesseldorf.de

Locations
Germany
German Diabetes Center Recruiting
Duesseldorf, NRW, Germany, 40225
Contact: Lejla Zahiragic, MD     00492118104819     lejla.zahiragic@med.uni-duesseldorf.de    
Contact: Bettina Nowotny, MD     00492113382-0 ext -575     bettina.nowotny@ddz.uni-duesseldorf.de    
Sub-Investigator: Lejla Zahiragic, MD            
Sub-Investigator: Bettina Nowotny, MD, M.Sc.            
Principal Investigator: Michael Roden, Professor, MD            
Charite, Department of Internal Medicine Active, not recruiting
Berlin, Germany
University Hospital, Department of Internal Medicine III Not yet recruiting
Dresden, Germany
Contact: Ulrike Schatz, MD            
Sub-Investigator: Ulrike Schatz, MD            
Principal Investigator: Stefan Bornstein, Professor, MD            
University Hospital, Department of Internal Medicine I Recruiting
Heidelberg, Germany
Contact: Jan Groener, MD         jan.groener@med.uni-heidelberg.de    
Sub-Investigator: Jan Groener, MD            
Principal Investigator: Peter Nawroth, Professor, MD            
Klinikum der Universität München (KUM) Active, not recruiting
Munich, Germany
University Hospital, Department of Internal Medicine IV Active, not recruiting
Tübingen, Germany
Sponsors and Collaborators
German Diabetes Center
Investigators
Study Director: Michael Roden, Professor, MD German Diabetes Center
  More Information

No publications provided

Responsible Party: German Diabetes Center
ClinicalTrials.gov Identifier: NCT01409330     History of Changes
Other Study ID Numbers: DDIET3521
Study First Received: June 8, 2011
Last Updated: August 21, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by German Diabetes Center:
insulin sensitivity
type 2 diabetes
diet intervention

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 16, 2013