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

March 16, 2021 updated by: Singapore General Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Glycine supplementation
Dietary supplement: Glycine
Oral glycine tablets (100 mg/kg/day) in divided doses

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insulin resistance index
Time Frame: 14 days
Post-treatment changes in insulin resistance index
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Singapore General Hospital

Collaborators

Baylor College of Medicine
National University Health System, Singapore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 20, 2021

Primary Completion (ANTICIPATED)

December 15, 2021

Study Completion (ANTICIPATED)

December 15, 2021

Study Registration Dates

First Submitted

December 1, 2020

First Submitted That Met QC Criteria

December 1, 2020

First Posted (ACTUAL)

December 8, 2020

Study Record Updates

Last Update Posted (ACTUAL)

March 17, 2021

Last Update Submitted That Met QC Criteria

March 16, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SGH-ENDO-Glycine002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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