Diabetes
Conditions
Brief 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
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
Interventions
DIETARY_SUPPLEMENTBranched-chain amino acids reduced intake
Sponsors
German Diabetes Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clamp test | up to 24 weeks | Insulin sensitivity test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mixed Meal Test | up to 24 weeks | B cell function test |
Countries
Germany
Outcome results
None listed