Glycine Deficiency and the Kinetics of Acylglycine in Morbid Obesity

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04658134

Enrollment

Registered

2020-12-08

Start date

2021-01-20

Completion date

2021-12-15

Last updated

2021-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glycine; Metabolic Disorder, Morbid Obesity

Keywords

Morbid obesity, Insulin Resistance, Glycine metabolism

Brief summary

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.

Interventions

DIETARY_SUPPLEMENTGlycine

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Amino acid concentration	14 days	Post-treatment changes amino acid concentration in plasma and red blood cell
Acylglycine concentration	14 days	Post-treatment changes acylglycine concentration in plasma and urine
Acylcarnitine concentration	14 days	Post-treatment changes acylcarnitine concentration in plasma and urine
Glutathione concentration	14 days	Post-treatment changes in glutathione concentration in plasma and red blood cell

Secondary

Measure	Time frame	Description
Insulin resistance index	14 days	Post-treatment changes in insulin resistance index

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026