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Completed

NCT Number: NCT01409330

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

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.

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Key information

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

German Diabetes Center, Düsseldorf, North Rhine-Westphalia, Germany

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

diet intervention

Dietary Supplement

8-week diet lacking red meat, but containing increased fibers and coffee (verum) versus standard recommendation (control) eating red meat.

Primary outcomes

  1. whole body insulin sensitivity

    Time frame: 8 weeks

    measurement of whole body insulin sensitivity with hyperinsulinamic euglicamic clamp

Secondary outcomes

  1. total body fat

    Time frame: 8 weeks

    MRI measurement of the effects of 8-week diet intervention on total body fat

  2. intramyocellular lipids

    Time frame: 8 weeks

    MRS measurement to investigate the effects of diet intervention on ectopic lipid content in skeletal muscle

  3. skeletal muscle mitochondrial function - insulin signaling

    Time frame: 8 weeks

    muscle biopsy for assessment of insulin signaling

  4. hepatocellular lipids

    Time frame: 8 weeks

    MRS measurement to investigate the effects of diet intervention on ectopic lipid content in liver(HCL)

  5. skeletal muscle mitochondrial function - phosphate-recovery time

    Time frame: 8 weeks

    skeletal muscle mitochondrial function in vivo assessed as phosphate-recovery time with MRS

  6. insulin secretion

    Time frame: 8 weeks

    measurement of insulin secretion with glucagon test, mixed-meal test and intravenous glucose tolerance test

  7. pancreatic fat

    Time frame: 8 weeks

    MRI measurement of the effects of 8-week diet intervention on pancreatic fat

Sponsors and collaborators

Lead sponsor

German Diabetes Center

Other

Registry information

Official study title

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

Acronym: DDIET

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Aug 4, 2011
Registry last updated
Jun 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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