Status:
UNKNOWN
The Effects of Glycine on Atherosclerosis and Metabolic Syndrome-related Parameters.
Lead Sponsor:
Prof. Tony hayek MD
Conditions:
Metabolic Syndrome
Dyslipidemias
Eligibility:
MALE
40-65 years
Phase:
PHASE2
PHASE3
Brief Summary
The current study will test the central hypothesis that Glycine supplementation in humans improves Lipid profile and therefore reduces the risk of Atherosclerosis. Secondary outcomes including Insulin...
Eligibility Criteria
Inclusion
- Male between the ages of 40-65 years old.
- Fulfill at least three of the five diagnostic criteria for the Metabolic Syndrome.
- To be able to give their written consent to participate in this study.
Exclusion
- Abnormal Liver function tests ≥ 3 times upper limit of normal (ULN).
- Chronic liver disease other than NAFLD.
- Previous gastric or small bowel surgery.
- Abnormal Thyroid-stimulating hormone (TSH) level.
- Known Tobacco Smoking more than 10 cigarettes per day.
- Known alcohol consumption more than 2 drink per day.
- Use of medications that include: Insulin or Insulin secretagogues, Thiazolidinediones, Glucocorticosteroids, Hormone replacement therapy.
- Fever \> 38.2 °C in the past 2 weeks.
- Autoimmune or Auto-inflammatory disease.
- Chronic kidney disease ≥ stage III.
- Nephrotic syndrome.
- Hemoglobin \<12 g/dL.
- Metal clips or implants that preclude magnetic resonance imaging.
Key Trial Info
Start Date :
March 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2020
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03850314
Start Date
March 1 2019
End Date
June 1 2020
Last Update
February 21 2019
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