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

Primary Purpose

Morbid Obesity, Glycine; Metabolic Disorder

Status
Unknown status
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Glycine
Sponsored by
Singapore General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Morbid Obesity focused on measuring Morbid obesity, Insulin Resistance, Glycine metabolism

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Singapore General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Glycine supplementation

Arm Description

Glycine supplementation

Outcomes

Primary Outcome Measures

Amino acid concentration
Post-treatment changes amino acid concentration in plasma and red blood cell
Acylglycine concentration
Post-treatment changes acylglycine concentration in plasma and urine
Acylcarnitine concentration
Post-treatment changes acylcarnitine concentration in plasma and urine
Glutathione concentration
Post-treatment changes in glutathione concentration in plasma and red blood cell

Secondary Outcome Measures

Insulin resistance index
Post-treatment changes in insulin resistance index

Full Information

First Posted
December 1, 2020
Last Updated
March 16, 2021
Sponsor
Singapore General Hospital
Collaborators
Baylor College of Medicine, National University Health System, Singapore
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1. Study Identification

Unique Protocol Identification Number
NCT04658134
Brief Title
Glycine "Deficiency" and the Kinetics of Acylglycine in Morbid Obesity
Official Title
Glycine "Deficiency" and the Kinetics of Acylglycine in Morbid Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 20, 2021 (Actual)
Primary Completion Date
December 15, 2021 (Anticipated)
Study Completion Date
December 15, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Singapore General Hospital
Collaborators
Baylor College of Medicine, National University Health System, Singapore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity, Glycine; Metabolic Disorder
Keywords
Morbid obesity, Insulin Resistance, Glycine metabolism

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Glycine supplementation
Arm Type
Experimental
Arm Description
Glycine supplementation
Intervention Type
Dietary Supplement
Intervention Name(s)
Glycine
Intervention Description
Oral glycine tablets (100 mg/kg/day) in divided doses
Primary Outcome Measure Information:
Title
Amino acid concentration
Description
Post-treatment changes amino acid concentration in plasma and red blood cell
Time Frame
14 days
Title
Acylglycine concentration
Description
Post-treatment changes acylglycine concentration in plasma and urine
Time Frame
14 days
Title
Acylcarnitine concentration
Description
Post-treatment changes acylcarnitine concentration in plasma and urine
Time Frame
14 days
Title
Glutathione concentration
Description
Post-treatment changes in glutathione concentration in plasma and red blood cell
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Insulin resistance index
Description
Post-treatment changes in insulin resistance index
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age: 21-65 years BMI ≥ 32.5 kg/m2 Able to provide informed consent Able to maintain present diet throughout the study duration Exclusion Criteria: Weight > 150 kg Type 2 Diabetes Mellitus Allergy to soy Ongoing treatment with weight-loss medications (e.g. orlistat, phentermine, liraglutide) Systemic steroid usage (eg. prednisolone, hydrocortisone, cortisone, dexamethasone) Renal impairment (estimated creatinine clearance estimated by Cockcroft-Gault Equation < 60 ml/min) Haemoglobin concentration < 10 g/L Serum alanine aminotransferase or aspartate aminotransferase above 2x upper limit of normal Uncontrolled hypertension (BP > 180/110 mmHg) Pregnancy Nursing mothers Uncontrolled thyroid disease Surgery requiring general anaesthesia within 4-weeks before enrolment Psychiatric disorders requiring medication Significant alcohol intake (> 1 unit per day for women and > 2 units per day for men) Cancer within the last 3-years (except squamous cell and basal cell cancer of the skin) Any factors likely to limit adherence to study protocol
Facility Information:
Facility Name
Singapore General Hospital
City
Singapore
ZIP/Postal Code
169856
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hong Chang Tan, MBBS, MMed
Phone
+65-63214658
Email
tan.hong.chang@sgh.com.sg
First Name & Middle Initial & Last Name & Degree
Vieon Wu
Phone
+65-63214658
Email
vieon.wu.aini@sgh.com.sg
First Name & Middle Initial & Last Name & Degree
Hong Chang Tan

12. IPD Sharing Statement

Learn more about this trial

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

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