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

June 2, 2023 updated by: German Diabetes Center

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
      • Düsseldorf, Germany, 40225
        • German Diabetes Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Amino acid powder with all amino acids
amino acid powder 80 g oral Administration 1 week
Dietary supplement: Branched-chain amino acids reduced intake
Active Comparator: Amino acid powder without BCAAs-reduced intake
Branched-chain amino acids reduced intake - amino acid powder lacking BCAAs 80 g oral Administration 1 week -
Dietary supplement: Branched-chain amino acids reduced intake

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clamp test
Time Frame: up to 24 weeks
Insulin sensitivity test
up to 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mixed Meal Test
Time Frame: up to 24 weeks
B cell function test
up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

German Diabetes Center

Investigators

  • Principal Investigator: Michael Roden, MD, Deutsches Diabetes Zentrum

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2016

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

August 22, 2017

First Submitted That Met QC Criteria

August 24, 2017

First Posted (Actual)

August 25, 2017

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

Other Study ID Numbers

  • 2014092783

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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