Ignite Creation Date:
2025-12-24 @ 5:41 PM
Ignite Modification Date:
2025-12-29 @ 3:48 AM
Study NCT ID:
NCT07212868
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-02
First Post:
2025-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role of Glucagon in Glucose Metabolism in Humans With and Without Bariatric Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Masking for participants'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Placebo controlled physiologic study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2030-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-24', 'studyFirstSubmitDate': '2025-09-22', 'studyFirstSubmitQcDate': '2025-10-01', 'lastUpdatePostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2030-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glycemc response to meal ingestion', 'timeFrame': '0 to 240 minutes', 'description': 'Changes in glucose response to meal ingestion occurred by administration of glucagon receptor antagonist (GRA).'}, {'measure': 'Endogenous glucose production (EGP) during clamp studies', 'timeFrame': '0 to 240 minutes', 'description': 'Changes in EGP (measured by tracer technique) with and without glucagon infusion'}], 'secondaryOutcomes': [{'measure': 'Prandial glucose kinetics', 'timeFrame': 'Baseline to 240 minutes', 'description': 'Glucose flux with and without GRA administration'}, {'measure': 'Plasma GLP-1, GIP, insulin and glucagon concentrations', 'timeFrame': '0 to 240 minutes', 'description': 'Changes in these outcomes following meal ingestion with and without GRA administration'}, {'measure': 'Glucose clearance and insulin and glucagon concentrations during clamp studies', 'timeFrame': '0 to 240 minutes', 'description': 'Outcomes with and without glucagon infusion'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['glucagon', 'glucose metabolism', 'bariatric surgery'], 'conditions': ['Non-Diabetic']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to understand the role of glucagon signal on glucose metabolism in individuals with and without bariatric surgery. The study is involved with measuring glucose metabolism with glucagon infusion and glucagon receptor blockade. We use an investigational drug called REMD 477. "Investigational" means that the has not yet been approved by the U.S. Food \\& Drug Administration (FDA). REMD-477 is a monoclonal antibody (an antibody made by cloning a unique white blood cell) that blocks the effect of glucagon.', 'detailedDescription': 'Participants will be screened, and if eligible will be enrolled for metabolic studies for two separate aims. In aim 1, they undergo glucose clamp study with and without glucagon infusion.\n\nIn aim 2, they undergo 2-day meal studies with and without a single dose administration of investigational drug, REMD 477 using a small needle subcutaneously. During these studies glycemic profile will be evaluated using CGM (Continuous glucose monitoring). Participants will also have a blood draw for liver enzymes8 weeks after the administration of REMD 477.\n\nParticipants will spend up to 3- 6 months participating in any pair study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form from participant.\n2. Male or female, ≤65 and ≥18 years old\n3. Subjects with history of gastric bypass surgery and sleeve gastrectomy more than a year since surgery and non-surgical subjects without history of gastrointestinal (GI) surgery\n4. HbA1c ≤6%\n5. Willing to adhere to the study intervention regimen\n6. Female subjects of childbearing potential must have a negative pregnancy test at screening and all the study visits, and must not be lactating\n7. Females of childbearing potential who are sexually active with a nonsterilized male partner must use at least one highly effective method of contraception from screening and must agree to continue using such precautions during the study.It is strongly recommended for the male partner of a female subject to also use male condom plus spermicide throughout this period. Cessation of contraception after this point should be discussed with a responsible physician. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception.\n\nExclusion Criteria:\n\n1. Diabetes\n2. Pregnancy/lactation\n3. Hgb \\<11\n4. Current GI obstruction or chronic diarrhea\n5. Subjects who are not within the age range of 18- 65 years.\n6. Evidence of active cardiorespiratory, hepatic, gastrointestinal or renal disease.\n7. History of allergy to the administered drugs.\n8. History of, or any existing condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product, put the subject at risk, influence the subject's ability to participate or affect the interpretation of the results of the study and/or any subject unable or unwilling to follow study procedures.\n9. Substance dependence or history of alcohol abuse and/or excess alcohol intake\n10. Patients on ketogenic diet\n11. Prisoners or institutionalized individuals\n12. AST (SGOT) \\> 3 times upper limit of normal\n13. ALT (SGPT) \\> 3 times upper limit of normal\n14. History of clinical hypoglycemia documents based on Whipples' triad (ONLY for Aim 2)"}, 'identificationModule': {'nctId': 'NCT07212868', 'briefTitle': 'The Role of Glucagon in Glucose Metabolism in Humans With and Without Bariatric Surgery', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center at San Antonio'}, 'officialTitle': 'The Role of Glucagon in Glucose Metabolism in Humans With and Without Bariatric Surgery', 'orgStudyIdInfo': {'id': 'STUDY00001597'}, 'secondaryIdInfos': [{'id': 'R01DK141843', 'link': 'https://reporter.nih.gov/quickSearch/R01DK141843', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mixed Meal study with and without glucagon receptor antagonist', 'description': 'Mixed meal test conducted with a sequential design of receiving a single dose subcutaneous injection of glucagon receptor antagonist or placebo.', 'interventionNames': ['Drug: REMD-477 versus Placebo']}, {'type': 'OTHER', 'label': 'Pancreatic clamp (hypoglycemia and hyperglycemic) with and without glucagon infusion', 'description': 'A cross-over study to compare the effect of glucagon infusion on glucose metabolism measured during clamp studies', 'interventionNames': ['Other: Exogenous glucagon versus saline infusion']}], 'interventions': [{'name': 'REMD-477 versus Placebo', 'type': 'DRUG', 'description': 'Placebo versus glucagon receptor antagonist using a human monoclonal antibody with a high level of antagonistic effect against human glucagon receptor.', 'armGroupLabels': ['Mixed Meal study with and without glucagon receptor antagonist']}, {'name': 'Exogenous glucagon versus saline infusion', 'type': 'OTHER', 'description': 'The effect of increased glucagon concentrations in plasma on glucose metabolism during glucose clamp will be studied.', 'armGroupLabels': ['Pancreatic clamp (hypoglycemia and hyperglycemic) with and without glucagon infusion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78207', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Diabetes Institute - University Health System', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'contacts': [{'name': 'Matthew A Davis', 'role': 'CONTACT', 'email': 'davism13@uthscsa.edu'}, {'name': 'Mooney Mark-Johnson', 'role': 'CONTACT', 'email': 'markjohnson@uthscsa.edu'}, {'name': 'Marzieh Salehi, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Texas San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'centralContacts': [{'name': 'Marzieh Salehi, MD, MS', 'role': 'CONTACT', 'email': 'davism13@uthscsa.edu', 'phone': '210-450-8560'}, {'name': 'Andrea Hansis-Diarte, MPh', 'role': 'CONTACT', 'email': 'hansisdiarte@uthscsa.edu', 'phone': '210-567-3208'}], 'overallOfficials': [{'name': 'Marzieh Salehi, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center at San Antonio'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'At study end after analysis of data.', 'ipdSharing': 'YES', 'description': 'Deidentified individual participant data summary results will be published in ClinicalTrials.gov as required by law and research findings will be published in a peer reviewed scientific journal.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center at San Antonio', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Marzieh Salehi', 'investigatorAffiliation': 'The University of Texas Health Science Center at San Antonio'}}}}