Clinical trial NCT03850314: The Effects of Glycine on Atherosclerosis and Metabolic Syndrome-related Parameters.
Official title: The Effects of Glycine on Atherosclerosis and Metabolic Syndrome-related Parameters: A Clinical and Ex-vivo Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Metabolic Syndrome
Dyslipidemias
Diabetes Mellitus
Obesity
Atherosclerosis
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2019-02-21
Enrollment: 50
Sex: MALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: LDL Cholesterol levels
timeFrame: 12 weeks
Secondary outcomes:
measure: Triglyceride levels
timeFrame: 12 weeks
measure: HDL Cholesterol levels
timeFrame: 12 weeks
measure: HbA1C levels
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Rambam Health Care Campus
name: Tony Hayek, MD
role: PRINCIPAL_INVESTIGATOR
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