Actively Recruiting
The Role of Glucagon in Glucose Metabolism in Humans With and Without Bariatric Surgery
Led by The University of Texas Health Science Center at San Antonio · Updated on 2026-05-11
150
Participants Needed
2
Research Sites
226 weeks
Total Duration
On this page
Sponsors
T
The University of Texas Health Science Center at San Antonio
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Role of Glucagon in Glucose Metabolism in Humans With and Without Bariatric Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form provided
- Male or female aged 18 to 65 years
- History of gastric bypass or sleeve gastrectomy surgery more than one year ago, or no history of gastrointestinal surgery
- HbA1c less than or equal to 6%
- Willingness to follow the study intervention plan
- For females of childbearing potential: negative pregnancy test at screening and all study visits, not lactating
- Sexually active females of childbearing potential with nonsterilized male partners must use at least one highly effective contraception method from screening through the study, with recommended condom plus spermicide use by male partner
You will not qualify if you...
- Diagnosis of diabetes
- Pregnancy or lactation
- Hemoglobin less than 11
- Current gastrointestinal obstruction or chronic diarrhea
- Age younger than 18 or older than 65 years
- Active heart, lung, liver, gastrointestinal, or kidney disease
- Allergy history to study drugs
- Any condition interfering with study safety, participation, or result interpretation
- Substance dependence, alcohol abuse, or excess intake history
- Following a ketogenic diet
- Prisoner or institutionalized status
- Liver enzymes AST (SGOT) or ALT (SGPT) more than 3 times the upper limit of normal
- History of clinical hypoglycemia based on Whipple's triad (for Aim 2)
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Texas Diabetes Institute - University Health System
San Antonio, Texas, United States, 78207
Actively Recruiting
2
University of Texas San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
Research Team
M
Marzieh Salehi, MD, MS
CONTACT
A
Andrea Hansis-Diarte, MPh
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
OTHER
Number of Arms
2
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