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OpenTrials
Completed

NCT Number: NCT03261362

Impact of Branched-chain Amino Acids in the Development of Insulin Resistance

The purpose of this study is to clarify the role of the branched-chain amino acids in the development of Insulin resistance in patients with diabetes

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Key information

Conditions

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

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

German Diabetes Centre

Düsseldorf, 40225, Germany

About this study

The proposed project aims to elucidate the role of the BCAA in the development of insulin resistance and type 2 diabetes. The project tests the hypothesis that a diet induced decrease of BCAAs concentrations alter the metabolic mechanisms involved in the control insulin resistance and diabetes progression.

The specific aims are to elucidate the effect of the diet induced decrease of BCAAs concentrations on (I) peripheral and hepatic insulin sensitivity (II) ectopic fat distribution (III) energy metabolism (IV) metabolic and inflammatory status

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diabetes type 2
  • Non smokers
  • Untrained
  • Willingness to adhere to a diet intervention

Exclusion criteria

  • Chronic disease
  • Pregnancy
  • Cancer
  • Antibiotic therapy
  • Drug/alcohol abuse
  • Competitive athletes

Treatment and study plan

Branched-chain amino acids reduced intake

Dietary Supplement

Primary outcomes

  1. Clamp test

    Time frame: up to 24 weeks

    Insulin sensitivity test

Secondary outcomes

  1. Mixed Meal Test

    Time frame: up to 24 weeks

    B cell function test

Sponsors and collaborators

Lead sponsor

German Diabetes Center

Other

Registry information

Official study title

Branched-Chain Amino Acid Dietary Reduction Under Weight Maintainance in Overweight Patients With Type 2 Diabetes

Acronym: BRAAWO

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Aug 25, 2017
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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