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

Prof. Tony hayek MD

Status and phase

Unknown

Phase 3

Phase 2

Conditions

Dyslipidemias

Diabetes Mellitus

Obesity

Atherosclerosis

Metabolic Syndrome

Treatments

Dietary Supplement: Glycine

Study type

Interventional

Funder types

Other

Identifiers

NCT03850314

RMB-18-0621

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

Male

Ages

40 to 65 years old

Volunteers

No Healthy Volunteers

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.