Status:
COMPLETED
Effect of Insulin Resistance on Branched Chain Amino Acid Metabolism.
Lead Sponsor:
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Conditions:
Obesity
Insulin Resistance
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief Summary
It has been observed that subjects with obesity and insulin resistance have higher concentrations of branched chain amino acids in plasma or serum. However, this association has been established under...
Detailed Description
An 8% crystalline L-amino acid solution with high concentrations of branched chain amino acids, leucine, isoleucine, and valine, will be administered intravenously. The dose will be calculated conside...
Eligibility Criteria
Inclusion
- Inclusion criteria for cases (subjects with insulin resistance).
- Male and female.
- Adults between 18 and 50 years of age.
- Body Mass Index (BMI) ≥ 18.5 and ≤ 40 kg/m2.
- HOMA index ≥ 2.5
- In the case of women, being in the follicular phase of the menstrual cycle.
- Inclusion criteria for controls (subjects without insulin resistance).
- Male and female
- Adults between 18 and 50 years of age.
- Body Mass Index (BMI) ≥ 18.5 and ≤ 40 kg/m2.
- HOMA index \< 2.5
- Blood glucose \< 100 mg/dL
- In the case of women, being in the follicular phase of the menstrual cycle.
Exclusion
- Patients with any type of diabetes.
- Patients with kidney disease diagnosed by any physician.
- Patients with creatinine \> 1.3 mg/dL for men and \> 1.1 mg/dL for women and/or Blood Urea Nitrogen (BUN) \> 20 mg/dL.
- Patients with acquired diseases secondarily producing obesity and diabetes.
- Patients who have suffered a cardiovascular event.
- Weight loss \> 3 kg in the last 3 months.
- Patients with any catabolic diseases.
- Pregnancy status.
- Positive smoking.
- Treatment with any medication (except contraceptives and proton pump inhibitors)
- Having suffered any infection in the last 20 days.
Key Trial Info
Start Date :
March 31 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 29 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04886973
Start Date
March 31 2022
End Date
July 29 2022
Last Update
August 2 2022
Active Locations (1)
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1
Instituto Nacional de Ciencias Medicas Y Nutricion Salvador Zubiran
México, Mexico, 14080