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

Prof. Tony hayek MD50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Metabolic Syndrome Dyslipidemias Diabetes Mellitus Obesity Atherosclerosis

Eligibility

Sex: MALEMin age: 40 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

LDL Cholesterol levels

Change in LDL Cholesterol levels

Time frame: 12 weeks

Secondary Outcomes

Triglyceride levels

Change in Triglyceride levels

Time frame: 12 weeks

HDL Cholesterol levels

Change in HDL Cholesterol levels

Time frame: 12 weeks

HbA1C levels

Change in Glycated hemoglobin (HbA1C) levels

Time frame: 12 weeks

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

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts