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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amino acid powder with all amino acids | Placebo Comparator | amino acid powder 80 g oral Administration 1 week |
|
| Amino acid powder without BCAAs-reduced intake | Active Comparator | Branched-chain amino acids reduced intake - amino acid powder lacking BCAAs 80 g oral Administration 1 week - |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Branched-chain amino acids reduced intake | Dietary Supplement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clamp test | Insulin sensitivity test | up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mixed Meal Test | B cell function test | up to 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Roden, MD | Deutsches Diabetes Zentrum | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| German Diabetes Centre | Düsseldorf | 40225 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31667519 | Derived | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 12, 2023 | |
| Reset | Feb 16, 2024 | |
| Release | Nov 16, 2024 | |
| Reset | Jan 9, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 12, 2023 | Feb 16, 2024 | |||
| Nov 16, 2024 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Jan 9, 2025 |