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The Role of Glucagon in Glucose Metabolism in Humans With and Without Bariatric Surgery

ConditionNon-Diabetic
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorThe University of Texas Health Science Center at San Antonio

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Provision of signed and dated informed consent form from participant.

Male or female, ≤65 and ≥18 years old

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

HbA1c ≤6%

Disqualifiers

Diabetes

Pregnancy/lactation

Hgb <11

Current GI obstruction or chronic diarrhea

Trial design

Design model

Sequential

Treatments tested in this trial

  • 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.

  • Exogenous glucagon versus saline infusion

    Other intervention

    The effect of increased glucagon concentrations in plasma on glucose metabolism during glucose clamp will be studied.

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Mixed Meal study with and without glucagon receptor antagonistExperimental treatment 1 intervention
Group B: Pancreatic clamp (hypoglycemia and hyperglycemic) with and without glucagon infusionOther 1 intervention

Trial outcomes

Primary outcomes

1

Glycemic response to meal ingestion

Changes in glucose response to meal ingestion occurred by administration of glucagon receptor antagonist (GRA).

Time frame
0 to 240 minutes
2

Endogenous glucose production (EGP) during clamp studies

Changes in EGP (measured by tracer technique) with and without glucagon infusion

Time frame
0 to 240 minutes

Secondary outcomes

1

Prandial glucose kinetics

Glucose flux with and without GRA administration

Time frame
Baseline to 240 minutes
2

Plasma GLP-1, GIP, insulin and glucagon concentrations

Changes in these outcomes following meal ingestion with and without GRA administration

Time frame
0 to 240 minutes
3

Glucose clearance and insulin and glucagon concentrations during clamp studies

Outcomes with and without glucagon infusion

Time frame
0 to 240 minutes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The University of Texas Health Science Center at San Antonio

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Source ClinicalTrials.gov
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