The Effects of Glycine on Atherosclerosis and Metabolic Syndrome-related Parameters.

Phase 2

• Conditions: Diabetes Mellitus; Atherosclerosis; Obesity; Dyslipidemias; Metabolic Syndrome
• Interventions: Dietary Supplement: Glycine

• Registration Number: NCT03850314
• Lead Sponsor: Prof. Tony hayek MD

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 sensitivity and parameters related to Metabolic Syndrome (MetS) will also be measured. Furthermore, a mechanistic study in an ex-vivo model will test the hypothesis that Glycine via its key biosynthetic pathway involving Serine Hydroxymethyltransferase 2 (SHMT2), is athero-protective by inhibiting Sterol regulatory element-binding protein 2 (SREBP2)-mediated cholesterol biosynthesis in murine macrophage-like cell line.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-02
• Study First Submitted: 2019-02-19
• Study First Submitted QC: 2019-02-20
• Last Update Submitted: 2019-02-20
• Study First Posted: 2019-02-21
• Last Update Posted: 2019-02-21
• Study Start: 2019-03
• Primary Completion: 2019-12
• Study Completion: 2020-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 50

Inclusion Criteria

• 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 Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Glycine	Glycine	Glycine total daily dose of 150mg/kg divided three times daily with meals (powder dissolved in 1 cup of water) for 12 weeks.

Primary Outcome Measures

Name	Time	Method
LDL Cholesterol levels	12 weeks	Change in LDL Cholesterol levels

Secondary Outcome Measures

Name	Time	Method
HDL Cholesterol levels	12 weeks	Change in HDL Cholesterol levels
HbA1C levels	12 weeks	Change in Glycated hemoglobin (HbA1C) levels
Triglyceride levels	12 weeks	Change in Triglyceride levels