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

NCT ID: NCT03261362

Last Updated: 2023-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2019-12-31

Brief Summary

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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

Detailed Description

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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

Conditions

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Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Amino acid powder with all amino acids

amino acid powder 80 g oral Administration 1 week

Group Type PLACEBO_COMPARATOR

Branched-chain amino acids reduced intake

Intervention Type DIETARY_SUPPLEMENT

Amino acid powder without BCAAs-reduced intake

Branched-chain amino acids reduced intake - amino acid powder lacking BCAAs 80 g oral Administration 1 week -

Group Type ACTIVE_COMPARATOR

Branched-chain amino acids reduced intake

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Branched-chain amino acids reduced intake

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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German Diabetes Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Roden, MD

Role: PRINCIPAL_INVESTIGATOR

Deutsches Diabetes Zentrum

Locations

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German Diabetes Centre

Düsseldorf, , Germany

Site Status

Countries

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Germany

References

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Karusheva Y, Koessler T, Strassburger K, Markgraf D, Mastrototaro L, Jelenik T, Simon MC, Pesta D, Zaharia OP, Bodis K, Barenz F, Schmoll D, Wolkersdorfer M, Tura A, Pacini G, Burkart V, Mussig K, Szendroedi J, Roden M. Short-term dietary reduction of branched-chain amino acids reduces meal-induced insulin secretion and modifies microbiome composition in type 2 diabetes: a randomized controlled crossover trial. Am J Clin Nutr. 2019 Nov 1;110(5):1098-1107. doi: 10.1093/ajcn/nqz191.

Reference Type DERIVED
PMID: 31667519 (View on PubMed)

Other Identifiers

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2014092783

Identifier Type: -

Identifier Source: org_study_id

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