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

Morbid Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04658134
• Other study ID #: SGH-ENDO-Glycine002
• Status: Recruiting
• Phase: N/A
• Start date: January 20, 2021
• Est. completion date: December 15, 2021

Study information

• Verified date: March 2021
• Source: Singapore General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 15, 2021
• Est. primary completion date: December 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Glycine; Metabolic Disorder
• Metabolic Diseases
• Morbid Obesity
• Obesity
• Obesity, Morbid

Intervention

Dietary Supplement:
• Glycine
Oral glycine tablets (100 mg/kg/day) in divided doses

Locations

Country	Name	City	State
Singapore	Singapore General Hospital	Singapore

Sponsors (3)

Lead Sponsor	Collaborator
Singapore General Hospital	Baylor College of Medicine, National University Health System, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amino acid concentration	Post-treatment changes amino acid concentration in plasma and red blood cell	14 days
Primary	Acylglycine concentration	Post-treatment changes acylglycine concentration in plasma and urine	14 days
Primary	Acylcarnitine concentration	Post-treatment changes acylcarnitine concentration in plasma and urine	14 days
Primary	Glutathione concentration	Post-treatment changes in glutathione concentration in plasma and red blood cell	14 days
Secondary	Insulin resistance index	Post-treatment changes in insulin resistance index	14 days