The Role of Glucagon in Glucose Metabolism in Humans With and Without Bariatric Surgery
The University of Texas Health Science Center at San Antonio
Summary
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.
Description
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 partic…
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: 1. Provision of signed and dated informed consent form from participant. 2. Male or female, ≤65 and ≥18 years old 3. 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 4. HbA1c ≤6% 5. Willing to adhere to the study intervention regimen 6. Female subjects of childbearing potential must have a negative pregnancy test at screening and all the study visits, and must not be lactating 7. Females of childbearing potential who are sexually active with a non…
Interventions
- DrugREMD-477 versus Placebo
Placebo versus glucagon receptor antagonist using a human monoclonal antibody with a high level of antagonistic effect against human glucagon receptor.
- OtherExogenous glucagon versus saline infusion
The effect of increased glucagon concentrations in plasma on glucose metabolism during glucose clamp will be studied.
Locations (2)
- Texas Diabetes Institute - University Health SystemSan Antonio, Texas
- University of Texas San AntonioSan Antonio, Texas