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

NCT ID: NCT03850314

Last Updated: 2019-02-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-31
• Study Completion Date: 2020-06-30

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.

Conditions

Metabolic Syndrome; Dyslipidemias; Diabetes Mellitus; Obesity; Atherosclerosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Glycine

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

Group Type: EXPERIMENTAL

Glycine

Intervention Type: DIETARY_SUPPLEMENT

Glycine powder to be dissolved in water.

Interventions

Glycine

Glycine powder to be dissolved in water.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Prof. Tony hayek MD

OTHER

Sponsor Role: lead

Responsible Party

Prof. Tony hayek MD

Director, Department of Internal Medicine "E".

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Tony Hayek, MD

Role: PRINCIPAL_INVESTIGATOR

Rambam Health Care Campus

Central Contacts

Tony Hayek, MD

Role: CONTACT

t_hayek@rmc.gov.il

+972523782009

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Other Identifiers

RMB-18-0621

Identifier Type: -

Identifier Source: org_study_id