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Metabolic SyndromePhase 2/3NCT03850314

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

A Phase 2/3 study testing Glycine in people with Metabolic Syndrome and Dyslipidemias, run by Prof. Tony hayek MD.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 65 years, men only
What is being tested?
Glycine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
No sites listed yet
Study dates
Mar 2019to Jun 2020
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 65 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 13Show fewer
  • 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.

Trial locations and contacts

No sites are listed yet.

Tony Hayek, MD contact

+972523782009

t_hayek@rmc.gov.il

About this study

Official title: 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.

Being tested
Glycine
Medical subject headings
Metabolic Syndrome, Dyslipidemias, Diabetes Mellitus, Obesity, Atherosclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GlycineDietary supplement

    Glycine powder to be dissolved in water.

Study groups in NCT03850314
Study groupRoleWhat they receive
GlycineExperimentalGlycine total daily dose of 150mg/kg divided three times daily with meals (powder dissolved in 1 cup of water) for 12 weeks.
Receives: Dietary Supplement: Glycine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. LDL Cholesterol levels

    Change in LDL Cholesterol levels

    Measured: 12 weeks

Secondary outcomes (3)

  1. Triglyceride levels

    Change in Triglyceride levels

    Measured: 12 weeks

  2. HDL Cholesterol levels

    Change in HDL Cholesterol levels

    Measured: 12 weeks

  3. HbA1C levels

    Change in Glycated hemoglobin (HbA1C) levels

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2019
  2. Study startMar 2019 (estimated)
  3. Primary completionDec 2019 (estimated)
  4. Study completionJun 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03850314
Sponsor's protocol ID
RMB-18-0621
Status last verified
Feb 2019
First submitted
19 Feb 2019
Last updated
21 Feb 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Moore KJ, Sheedy FJ, Fisher EA. Macrophages in atherosclerosis: a dynamic balance. Nat Rev Immunol. 2013 Oct;13(10):709-21. doi: 10.1038/nri3520. Epub 2013 Sep 2.

    PubMed 23995626

  • Weber C, Noels H. Atherosclerosis: current pathogenesis and therapeutic options. Nat Med. 2011 Nov 7;17(11):1410-22. doi: 10.1038/nm.2538.

    PubMed 22064431

  • Michas G, Micha R, Zampelas A. Dietary fats and cardiovascular disease: putting together the pieces of a complicated puzzle. Atherosclerosis. 2014 Jun;234(2):320-8. doi: 10.1016/j.atherosclerosis.2014.03.013. Epub 2014 Mar 27.

    PubMed 24727233

  • Sacks FM, Lichtenstein AH, Wu JHY, Appel LJ, Creager MA, Kris-Etherton PM, Miller M, Rimm EB, Rudel LL, Robinson JG, Stone NJ, Van Horn LV; American Heart Association. Dietary Fats and Cardiovascular Disease: A Presidential Advisory From the American Heart Association. Circulation. 2017 Jul 18;136(3):e1-e23. doi: 10.1161/CIR.0000000000000510. Epub 2017 Jun 15.

    PubMed 28620111

  • Rom O, Aviram M. It is not just lipids: proatherogenic vs. antiatherogenic roles for amino acids in macrophage foam cell formation. Curr Opin Lipidol. 2017 Feb;28(1):85-87. doi: 10.1097/MOL.0000000000000377. No abstract available.

    PubMed 28030455

  • Shah SH, Bain JR, Muehlbauer MJ, Stevens RD, Crosslin DR, Haynes C, Dungan J, Newby LK, Hauser ER, Ginsburg GS, Newgard CB, Kraus WE. Association of a peripheral blood metabolic profile with coronary artery disease and risk of subsequent cardiovascular events. Circ Cardiovasc Genet. 2010 Apr;3(2):207-14. doi: 10.1161/CIRCGENETICS.109.852814. Epub 2010 Feb 19.

    PubMed 20173117

  • Wurtz P, Raiko JR, Magnussen CG, Soininen P, Kangas AJ, Tynkkynen T, Thomson R, Laatikainen R, Savolainen MJ, Laurikka J, Kuukasjarvi P, Tarkka M, Karhunen PJ, Jula A, Viikari JS, Kahonen M, Lehtimaki T, Juonala M, Ala-Korpela M, Raitakari OT. High-throughput quantification of circulating metabolites improves prediction of subclinical atherosclerosis. Eur Heart J. 2012 Sep;33(18):2307-16. doi: 10.1093/eurheartj/ehs020. Epub 2012 Mar 26.

    PubMed 22450427

  • Bhattacharya S, Granger CB, Craig D, Haynes C, Bain J, Stevens RD, Hauser ER, Newgard CB, Kraus WE, Newby LK, Shah SH. Validation of the association between a branched chain amino acid metabolite profile and extremes of coronary artery disease in patients referred for cardiac catheterization. Atherosclerosis. 2014 Jan;232(1):191-6. doi: 10.1016/j.atherosclerosis.2013.10.036. Epub 2013 Nov 12.

    PubMed 24401236

  • Yang R, Dong J, Zhao H, Li H, Guo H, Wang S, Zhang C, Wang S, Wang M, Yu S, Chen W. Association of branched-chain amino acids with carotid intima-media thickness and coronary artery disease risk factors. PLoS One. 2014 Jun 9;9(6):e99598. doi: 10.1371/journal.pone.0099598. eCollection 2014.

    PubMed 24910999

  • Yang RY, Wang SM, Sun L, Liu JM, Li HX, Sui XF, Wang M, Xiu HL, Wang S, He Q, Dong J, Chen WX. Association of branched-chain amino acids with coronary artery disease: A matched-pair case-control study. Nutr Metab Cardiovasc Dis. 2015 Oct;25(10):937-42. doi: 10.1016/j.numecd.2015.06.003. Epub 2015 Jun 14.

    PubMed 26231617

  • Grajeda-Iglesias C, Aviram M. Specific Amino Acids Affect Cardiovascular Diseases and Atherogenesis via Protection against Macrophage Foam Cell Formation: Review Article. Rambam Maimonides Med J. 2018 Jul 30;9(3):e0022. doi: 10.5041/RMMJ.10337.

    PubMed 29944113

  • Ding Y, Svingen GF, Pedersen ER, Gregory JF, Ueland PM, Tell GS, Nygard OK. Plasma Glycine and Risk of Acute Myocardial Infarction in Patients With Suspected Stable Angina Pectoris. J Am Heart Assoc. 2015 Dec 31;5(1):e002621. doi: 10.1161/JAHA.115.002621.

    PubMed 26722126

  • Rom O, Aviram M. Endogenous or exogenous antioxidants vs. pro-oxidants in macrophage atherogenicity. Curr Opin Lipidol. 2016 Apr;27(2):204-6. doi: 10.1097/MOL.0000000000000287. No abstract available.

    PubMed 26959710

  • Rom O, Grajeda-Iglesias C, Najjar M, Abu-Saleh N, Volkova N, Dar DE, Hayek T, Aviram M. Atherogenicity of amino acids in the lipid-laden macrophage model system in vitro and in atherosclerotic mice: a key role for triglyceride metabolism. J Nutr Biochem. 2017 Jul;45:24-38. doi: 10.1016/j.jnutbio.2017.02.023. Epub 2017 Apr 6.

    PubMed 28431321

  • Yan-Do R, MacDonald PE. Impaired "Glycine"-mia in Type 2 Diabetes and Potential Mechanisms Contributing to Glucose Homeostasis. Endocrinology. 2017 May 1;158(5):1064-1073. doi: 10.1210/en.2017-00148.

    PubMed 28323968

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Glycine in people with Metabolic Syndrome and Dyslipidemias, run by Prof. Tony hayek MD.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Tony Hayek, MD (+972523782009, t_hayek@rmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

LDL Cholesterol levels (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03850314, which also lists 34 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2019.

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