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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04658134
Recruitment Status : Unknown
Verified March 2021 by Singapore General Hospital.
Recruitment status was:  Recruiting
First Posted : December 8, 2020
Last Update Posted : March 17, 2021
Sponsor:
Collaborators:
Baylor College of Medicine
National University Health System, Singapore
Information provided by (Responsible Party):
Singapore General Hospital

Study Description
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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.


Condition or disease Intervention/treatment Phase
Morbid Obesity Glycine; Metabolic Disorder Dietary Supplement: Glycine Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Glycine "Deficiency" and the Kinetics of Acylglycine in Morbid Obesity
Actual Study Start Date : January 20, 2021
Estimated Primary Completion Date : December 15, 2021
Estimated Study Completion Date : December 15, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Glycine

Arms and Interventions
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Arm Intervention/treatment
Experimental: Glycine supplementation
Glycine supplementation
 Dietary Supplement: Glycine
Oral glycine tablets (100 mg/kg/day) in divided doses


Outcome Measures
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Primary Outcome Measures :
  1. Amino acid concentration [ Time Frame: 14 days ]
    Post-treatment changes amino acid concentration in plasma and red blood cell

  2. Acylglycine concentration [ Time Frame: 14 days ]
    Post-treatment changes acylglycine concentration in plasma and urine

  3. Acylcarnitine concentration [ Time Frame: 14 days ]
    Post-treatment changes acylcarnitine concentration in plasma and urine

  4. Glutathione concentration [ Time Frame: 14 days ]
    Post-treatment changes in glutathione concentration in plasma and red blood cell


Secondary Outcome Measures :
  1. Insulin resistance index [ Time Frame: 14 days ]
    Post-treatment changes in insulin resistance index


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04658134


Locations
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Singapore
Singapore General Hospital Recruiting
Singapore, Singapore, 169856
Contact: Hong Chang Tan, MBBS, MMed    +65-63214658    tan.hong.chang@sgh.com.sg   
Contact: Vieon Wu    +65-63214658    vieon.wu.aini@sgh.com.sg   
Principal Investigator: Hong Chang Tan         
Sponsors and Collaborators
Singapore General Hospital
Baylor College of Medicine
National University Health System, Singapore
More Information
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Responsible Party: Singapore General Hospital
ClinicalTrials.gov Identifier: NCT04658134    
Other Study ID Numbers: SGH-ENDO-Glycine002
First Posted: December 8, 2020    Key Record Dates
Last Update Posted: March 17, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Singapore General Hospital:
Morbid obesity
Insulin Resistance
Glycine metabolism
Additional relevant MeSH terms:
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Obesity
Obesity, Morbid
Metabolic Diseases
Overweight
Overnutrition
Nutrition Disorders
 Body Weight
Glycine
Glycine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs