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

NCT03261362 — Not applicable, Completed, 12 participants, German Diabetes Center

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

Registry	NCT03261362, acronym BRAAWO
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, crossover, masking: quadruple, prevention
Enrollment	12 (Actual)
Sponsor	German Diabetes Center (Other)
Conditions	Diabetes
Interventions	Branched-chain amino acids reduced intake (Dietary supplement)
Dates	start 2016-03-01, primary completion 2019-12-31, completion 2019-12-31, first posted 2017-08-25, last updated 2023-06-05
Locations	1 site in Germany

-Summary

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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+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

+Arms and interventions

Arm	Type	Interventions	Description
Amino acid powder with all amino acids	Placebo comparator	Dietary Supplement: Branched-chain amino acids reduced intake	amino acid powder 80 g oral Administration 1 week
Amino acid powder without BCAAs-reduced intake	Active comparator	Dietary Supplement: Branched-chain amino acids reduced intake	Branched-chain amino acids reduced intake - amino acid powder lacking BCAAs 80 g oral Administration 1 week -

Branched-chain amino acids reduced intake (Dietary supplement)

+Outcome measures

Primary outcomes

Clamp test [up to 24 weeks]: Insulin sensitivity test

Secondary outcomes

Mixed Meal Test [up to 24 weeks]: B cell function test

+Eligibility

Sex: All, ages: 30 Years to 60 Years

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

+Locations (1)

Facility	City	Country	Status
German Diabetes Centre	Düsseldorf	Germany

+Publications

Results publication: 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. PMID 31667519

+Investigators

Michael Roden, MD, Principal investigator, Deutsches Diabetes Zentrum