Role of GLP-1 in Hyperinsulinemic Hypoglycemia Post-bariatric Surgery

Phase 1

Terminated

• Conditions: Hypoglycemia
• Interventions: Other: Placebo; Drug: Exendin (9-39)

• Registration Number: NCT02550145
• Lead Sponsor: Tracey McLaughlin

Brief Summary

The purpose of this study is to evaluate the role of GLP-1 in causing extreme postprandial glucose reductions after bariatric surgery in a subset of patients who have severe symptomatic hypoglycemia.

Detailed Description

The physiologic mechanisms mediating the glucose-lowering effect of Roux-en-Y Gastric Bypass (RYGB) or post-Vertical Sleeve Gastrectomy (VSG) are unknown. The reduction in glucose excursions prior to weight loss has lead to postulates that the incretin hormone, GLP-1, may play an important role.

The purpose of this study is to evaluate the role of GLP-1 in causing extreme postprandial glucose reductions in a subset of post-bariatric patients through the pharmacologic blockade of the GLP-1 receptor in post-RYGB or post-VSG patients with severe symptomatic hypoglycemia.

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2015-06-05
• Study First Submitted QC: 2015-09-14
• Study First Posted: 2015-09-15
• Primary Completion: 2016-12
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-02
• Last Update Posted: 2024-12-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Men and women ages 18-65
• BMI 25-40 with a clinical diagnosis of severe symptomatic hypoglycemia after bariatric surgery

Exclusion Criteria

• Acute medical illness, such as acute bacterial or viral syndrome, febrile illness, acute abdominal symptoms, orthopedic injury within one week
• History of cardiac failure, renal insufficiency (estimated Crcl<30cc/min), hepatic insufficiency, chronic obstructive pulmonary disease, anemia (Hct<30%), or uncontrolled hypertension (SBP>160 or DBP>100)
• Pregnancy
• Use of medications that affect glucose metabolism
• Fasting glucose >150 or HbA1c>7.5 on Metformin
• Women of childbearing potential (will have a pregnancy test, in addition use of abstinence for at least one month prior to study or use two types of contraceptives, hormonal implant or Depo Provera)
• Active, uncontrolled psychiatric disease
• Participating in other studies or have received investigational medications within the past month or 5 half-lives of the drug, whichever is longer.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	IV infusion of normal saline
Exendin(9-39)	Exendin (9-39)	IV infusion of Exendin (9-39).

Primary Outcome Measures

Name	Time	Method
Plasma glucose area under the curve	0 to 180 minutes

Secondary Outcome Measures

Name	Time	Method
Plasma insulin area under the curve	0 to 180 minutes

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States