Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2026-03-07 @ 10:43 PM
Study NCT ID:
NCT04658134
Status:
UNKNOWN
Last Update Posted:
2021-03-17
First Post:
2020-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Glycine "Deficiency" and the Kinetics of Acylglycine in Morbid Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009767', 'term': 'Obesity, Morbid'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005998', 'term': 'Glycine'}], 'ancestors': [{'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-16', 'studyFirstSubmitDate': '2020-12-01', 'studyFirstSubmitQcDate': '2020-12-01', 'lastUpdatePostDateStruct': {'date': '2021-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Amino acid concentration', 'timeFrame': '14 days', 'description': 'Post-treatment changes amino acid concentration in plasma and red blood cell'}, {'measure': 'Acylglycine concentration', 'timeFrame': '14 days', 'description': 'Post-treatment changes acylglycine concentration in plasma and urine'}, {'measure': 'Acylcarnitine concentration', 'timeFrame': '14 days', 'description': 'Post-treatment changes acylcarnitine concentration in plasma and urine'}, {'measure': 'Glutathione concentration', 'timeFrame': '14 days', 'description': 'Post-treatment changes in glutathione concentration in plasma and red blood cell'}], 'secondaryOutcomes': [{'measure': 'Insulin resistance index', 'timeFrame': '14 days', 'description': 'Post-treatment changes in insulin resistance index'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Morbid obesity', 'Insulin Resistance', 'Glycine metabolism'], 'conditions': ['Morbid Obesity', 'Glycine; Metabolic Disorder']}, 'referencesModule': {'references': [{'pmid': '41107432', 'type': 'DERIVED', 'citation': 'Tan HC, Hsu JW, Tai ES, Chacko S, Wu V, Yen PM, Kovalik JP, Jahoor F. Metabolic impact of dietary glycine supplementation in individuals with severe obesity. Sci Rep. 2025 Oct 17;15(1):36433. doi: 10.1038/s41598-025-20511-x.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThis 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age: 21-65 years\n2. BMI ≥ 32.5 kg/m2\n3. Able to provide informed consent\n4. Able to maintain present diet throughout the study duration\n\nExclusion Criteria:\n\n1. Weight \\> 150 kg\n2. Type 2 Diabetes Mellitus\n3. Allergy to soy\n4. Ongoing treatment with weight-loss medications (e.g. orlistat, phentermine, liraglutide)\n5. Systemic steroid usage (eg. prednisolone, hydrocortisone, cortisone, dexamethasone)\n6. Renal impairment (estimated creatinine clearance estimated by Cockcroft-Gault Equation \\< 60 ml/min)\n7. Haemoglobin concentration \\< 10 g/L\n8. Serum alanine aminotransferase or aspartate aminotransferase above 2x upper limit of normal\n9. Uncontrolled hypertension (BP \\> 180/110 mmHg)\n10. Pregnancy\n11. Nursing mothers\n12. Uncontrolled thyroid disease\n13. Surgery requiring general anaesthesia within 4-weeks before enrolment\n14. Psychiatric disorders requiring medication\n15. Significant alcohol intake (\\> 1 unit per day for women and \\> 2 units per day for men)\n16. Cancer within the last 3-years (except squamous cell and basal cell cancer of the skin)\n17. Any factors likely to limit adherence to study protocol'}, 'identificationModule': {'nctId': 'NCT04658134', 'briefTitle': 'Glycine "Deficiency" and the Kinetics of Acylglycine in Morbid Obesity', 'organization': {'class': 'OTHER', 'fullName': 'Singapore General Hospital'}, 'officialTitle': 'Glycine "Deficiency" and the Kinetics of Acylglycine in Morbid Obesity', 'orgStudyIdInfo': {'id': 'SGH-ENDO-Glycine002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Glycine supplementation', 'description': 'Glycine supplementation', 'interventionNames': ['Dietary Supplement: Glycine']}], 'interventions': [{'name': 'Glycine', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Oral glycine tablets (100 mg/kg/day) in divided doses', 'armGroupLabels': ['Glycine supplementation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '169856', 'city': 'Singapore', 'status': 'RECRUITING', 'country': 'Singapore', 'contacts': [{'name': 'Hong Chang Tan, MBBS, MMed', 'role': 'CONTACT', 'email': 'tan.hong.chang@sgh.com.sg', 'phone': '+65-63214658'}, {'name': 'Vieon Wu', 'role': 'CONTACT', 'email': 'vieon.wu.aini@sgh.com.sg', 'phone': '+65-63214658'}, {'name': 'Hong Chang Tan', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Singapore General Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Singapore General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Baylor College of Medicine', 'class': 'OTHER'}, {'name': 'National University Health System, Singapore', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}