Glycine "Deficiency" and the Kinetics of Acylglycine in Morbid Obesity

NCT ID: NCT04658134

Last Updated: 2021-03-17

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-20

Study Completion Date

2021-12-15

Brief Summary

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This study aims to evaluate the effects of oral glycine supplementation on plasma glycine concentration, intracellular glutathione (GSH) concentration, plasma acylglycine concentration, urine acylglycine concentration, and insulin resistance in subjects with morbid obesity.

This is an open-labelled trial. 20 adults with morbid obesity will be recruited. Following screening and baseline metabolic evaluations, eligible subjects will be given oral glycine supplements for 14 ± 5 days. Upon completing glycine supplementation, subjects will return for their post-supplement metabolic assessment.

The investigators hypothesize that oral glycine supplementation in morbidly obese patients normalizes plasma glycine concentration, increases intracellular GSH concentration, increases plasma and urinary acylglycine concentration, and improves insulin resistance.

Detailed Description

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Conditions

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Morbid Obesity Glycine; Metabolic Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Glycine supplementation

Glycine supplementation

Group Type EXPERIMENTAL

Glycine

Intervention Type DIETARY_SUPPLEMENT

Oral glycine tablets (100 mg/kg/day) in divided doses

Interventions

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Glycine

Oral glycine tablets (100 mg/kg/day) in divided doses

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

1. Age: 21-65 years
2. BMI ≥ 32.5 kg/m2
3. Able to provide informed consent
4. Able to maintain present diet throughout the study duration

Exclusion Criteria

1. Weight \> 150 kg
2. Type 2 Diabetes Mellitus
3. Allergy to soy
4. Ongoing treatment with weight-loss medications (e.g. orlistat, phentermine, liraglutide)
5. Systemic steroid usage (eg. prednisolone, hydrocortisone, cortisone, dexamethasone)
6. Renal impairment (estimated creatinine clearance estimated by Cockcroft-Gault Equation \< 60 ml/min)
7. Haemoglobin concentration \< 10 g/L
8. Serum alanine aminotransferase or aspartate aminotransferase above 2x upper limit of normal
9. Uncontrolled hypertension (BP \> 180/110 mmHg)
10. Pregnancy
11. Nursing mothers
12. Uncontrolled thyroid disease
13. Surgery requiring general anaesthesia within 4-weeks before enrolment
14. Psychiatric disorders requiring medication
15. Significant alcohol intake (\> 1 unit per day for women and \> 2 units per day for men)
16. Cancer within the last 3-years (except squamous cell and basal cell cancer of the skin)
17. Any factors likely to limit adherence to study protocol
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Baylor College of Medicine

OTHER

Sponsor Role collaborator

National University Health System, Singapore

OTHER

Sponsor Role collaborator

Singapore General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Singapore General Hospital

Singapore, , Singapore

Site Status RECRUITING

Countries

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Singapore

Facility Contacts

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Hong Chang Tan, MBBS, MMed

Role: primary

+65-63214658

Vieon Wu

Role: backup

+65-63214658

References

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Tan HC, Hsu JW, Tai ES, Chacko S, Wu V, Yen PM, Kovalik JP, Jahoor F. Metabolic impact of dietary glycine supplementation in individuals with severe obesity. Sci Rep. 2025 Oct 17;15(1):36433. doi: 10.1038/s41598-025-20511-x.

Reference Type DERIVED
PMID: 41107432 (View on PubMed)

Other Identifiers

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SGH-ENDO-Glycine002

Identifier Type: -

Identifier Source: org_study_id

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