Obesity-Related Glycine Deficiency: Investigating a Long-standing Metabolic Paradox Using Bedside and Bench Approaches
NCT ID: NCT04660513
Last Updated: 2020-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
42 participants
OBSERVATIONAL
2018-12-08
2020-11-04
Brief Summary
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The overall aim of this project is to comprehensively study glycine metabolic pathways in morbid obesity using stable-isotope tracer techniques in human subjects and validating kinetic findings using a cell model of oxidative stress.
This will be a single-centre, observational study. 21 individuals with morbid obesity scheduled for bariatric surgery and 21 non-obese controls will be recruit. They will undergo different study visits and procedures and the human biological materials collected will be analysed for as per aims of the studies. We believe that the glycine metabolic pathways, possibly through the optimization of gluthathione (GSH) synthesis, may provide targets to develop novel therapeutic agents.
Detailed Description
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Conditions
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Morbid obesity
BMI 32.5 kg/m2 and above
Bariatric surgery
Subjects with morbid obesity underwent bariatric surgery
Non-obese healthy controls
BMI below 25 kg/m2
No interventions assigned to this group
Interventions
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Bariatric surgery
Subjects with morbid obesity underwent bariatric surgery
Eligibility Criteria
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Inclusion Criteria
2. BMI \< 25 kg/m2 for non-obese controls or BMI ≥ 32.5 kg/m2 for obese subjects scheduled for bariatric surgery
3. Able to provide informed consent
Exclusion Criteria
1. Weight \> 150 kg
2. Renal impairment (estimated creatinine clearance estimated by Cockcroft-Gault Equation \< 60 ml/min)
3. Haemoglobin concentration \< 10 g/L
4. Serum alanine aminotransferase or aspartate aminotransferase above 2x upper limit of normal
5. Uncontrolled hypertension (BP \> 180/110 mmHg)
6. Pregnancy
7. Nursing mothers
8. Significant cardiovascular disease (e.g. acute myocardial infarction, congestive cardiac failure, ischemic heart disease, atrial fibrillation, sick sinus syndrome, supraventricular tachycardia)
9. Previous stroke
10. Uncontrolled thyroid disease
11. Surgery requiring general anaesthesia within 4-weeks before enrolment
12. Psychiatric disorders requiring medication
13. Significant alcohol intake (\> 1 unit per day for women and \> 2 units per day for men)
14. Subcutaneous insulin injections
15. Systemic steroid usage (eg. prednisolone, hydrocortisone, cortisone, dexamethasone)
16. Cancer within the last 5-years (except squamous cell and basal cell cancer of the skin)
17. Any factors likely to limit adherence to study protocol (e.g. dementia; alcohol or substance abuse; history of unreliability in medication taking or appointment keeping; significant concerns about participation in the study from spouse, significant other or family members)
Non-obese controls 1. Known Diabetes Mellitus (diagnosed according to 2014 Ministry of Health Clinical Practice Guidelines for Diabetes Mellitus)
Obese subjects
1\. HbA1C \< 9%
21 Years
65 Years
ALL
No
Sponsors
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Duke-NUS Graduate Medical School
OTHER
Baylor College of Medicine
OTHER
National University Health System, Singapore
OTHER
Singapore General Hospital
OTHER
Responsible Party
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Locations
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Singapore General Hospital
Singapore, , Singapore
Countries
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References
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Tan HC, Hsu JW, Tai ES, Chacko S, Kovalik JP, Jahoor F. The impact of obesity-associated glycine deficiency on the elimination of endogenous and exogenous metabolites via the glycine conjugation pathway. Front Endocrinol (Lausanne). 2024 Apr 3;15:1343738. doi: 10.3389/fendo.2024.1343738. eCollection 2024.
Tan HC, Hsu JW, Tai ES, Chacko S, Wu V, Lee CF, Kovalik JP, Jahoor F. De Novo Glycine Synthesis Is Reduced in Adults With Morbid Obesity and Increases Following Bariatric Surgery. Front Endocrinol (Lausanne). 2022 Jun 9;13:900343. doi: 10.3389/fendo.2022.900343. eCollection 2022.
Other Identifiers
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SGH-ENDO-GlycineTA-001
Identifier Type: -
Identifier Source: org_study_id