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

Not Applicable

• Conditions: Glycine; Metabolic Disorder; Morbid Obesity
• Interventions: Dietary Supplement: Glycine

• Registration Number: NCT04658134
• Lead Sponsor: Singapore General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-01
• Study First Submitted QC: 2020-12-01
• Study First Posted: 2020-12-08
• Study Start: 2021-01-20
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-16
• Last Update Posted: 2021-03-17
• Primary Completion: 2021-12-15
• Study Completion: 2021-12-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Glycine supplementation	Glycine	Glycine supplementation

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Insulin resistance index	14 days	Post-treatment changes in insulin resistance index

Trial Locations

Locations (1)

Singapore General Hospital; 🇸🇬 Singapore, Singapore