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

NCT03850314 | Unknown Phase 2

• 1 other identifier: RMB-18-0621
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• LDL Cholesterol levels

  Change in LDL Cholesterol levels

  12 weeks

Secondary Outcomes (3)

• Triglyceride levels

  12 weeks

• HDL Cholesterol levels

  12 weeks

• HbA1C levels

  12 weeks

Study Arms (1)

Glycine

EXPERIMENTAL

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

Interventions

Glycine DIETARY_SUPPLEMENT

Glycine powder to be dissolved in water.

Glycine

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Prof. Tony hayek MD: lead

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MeSH Terms

Conditions

Metabolic Syndrome; Dyslipidemias; Diabetes Mellitus; Obesity; Atherosclerosis

Interventions

Glycine

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Lipid Metabolism Disorders; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Tony Hayek, MD

  Rambam Health Care Campus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tony Hayek, MD

CONTACT

+972523782009; t_hayek@rmc.gov.il

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Department of Internal Medicine "E".

Study Record Dates

• First Submitted: February 19, 2019
• First Posted: February 21, 2019
• Study Start: March 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: June 1, 2020
• Last Updated: February 21, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share