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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK141843 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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.
In 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.
Participants will spend up to 3- 6 months participating in any pair study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mixed Meal study with and without glucagon receptor antagonist | Experimental | Mixed meal test conducted with a sequential design of receiving a single dose subcutaneous injection of glucagon receptor antagonist or placebo. |
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| Pancreatic clamp (hypoglycemia and hyperglycemic) with and without glucagon infusion | Other | A cross-over study to compare the effect of glucagon infusion on glucose metabolism measured during clamp studies |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REMD-477 versus Placebo | Drug | Placebo versus glucagon receptor antagonist using a human monoclonal antibody with a high level of antagonistic effect against human glucagon receptor. |
| Measure | Description | Time Frame |
|---|---|---|
| Glycemc response to meal ingestion | Changes in glucose response to meal ingestion occurred by administration of glucagon receptor antagonist (GRA). | 0 to 240 minutes |
| Endogenous glucose production (EGP) during clamp studies | Changes in EGP (measured by tracer technique) with and without glucagon infusion | 0 to 240 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Prandial glucose kinetics | Glucose flux with and without GRA administration | Baseline to 240 minutes |
| Plasma GLP-1, GIP, insulin and glucagon concentrations | Changes in these outcomes following meal ingestion with and without GRA administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marzieh Salehi, MD, MS | Contact | 210-450-8560 | davism13@uthscsa.edu | |
| Andrea Hansis-Diarte, MPh | Contact | 210-567-3208 | hansisdiarte@uthscsa.edu |
| Name | Affiliation | Role |
|---|---|---|
| Marzieh Salehi, MD, MS | The University of Texas Health Science Center at San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas Diabetes Institute - University Health System | Recruiting | San Antonio | Texas | 78207 | United States |
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.
At study end after analysis of data.
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Placebo controlled physiologic study
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Masking for participants
| Exogenous glucagon versus saline infusion | Other | The effect of increased glucagon concentrations in plasma on glucose metabolism during glucose clamp will be studied. |
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| 0 to 240 minutes |
| Glucose clearance and insulin and glucagon concentrations during clamp studies | Outcomes with and without glucagon infusion | 0 to 240 minutes |
| University of Texas San Antonio | Recruiting | San Antonio | Texas | 78229 | United States |
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