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

February 20, 2019 updated by: Prof. Tony hayek MD

The Effects of Glycine on Atherosclerosis and Metabolic Syndrome-related Parameters: A Clinical and Ex-vivo Study.

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

38 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Glycine
Glycine total daily dose of 150mg/kg divided three times daily with meals (powder dissolved in 1 cup of water) for 12 weeks.
Dietary supplement: Glycine
Glycine powder to be dissolved in water.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
LDL Cholesterol levels
Time Frame: 12 weeks
Change in LDL Cholesterol levels
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Triglyceride levels
Time Frame: 12 weeks
Change in Triglyceride levels
12 weeks
HDL Cholesterol levels
Time Frame: 12 weeks
Change in HDL Cholesterol levels
12 weeks
HbA1C levels
Time Frame: 12 weeks
Change in Glycated hemoglobin (HbA1C) levels
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prof. Tony hayek MD

Investigators

  • Principal Investigator: Tony Hayek, MD, Rambam Health Care Campus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2019

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

June 1, 2020

Study Registration Dates

First Submitted

February 19, 2019

First Submitted That Met QC Criteria

February 20, 2019

First Posted (Actual)

February 21, 2019

Study Record Updates

Last Update Posted (Actual)

February 21, 2019

Last Update Submitted That Met QC Criteria

February 20, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RMB-18-0621

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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