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

NCT ID: NCT02550145

Last Updated: 2024-12-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28

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.

Conditions

Hypoglycemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Exendin(9-39)

IV infusion of Exendin (9-39).

Group Type: EXPERIMENTAL

Exendin (9-39)

Intervention Type: DRUG

IV infusion of Exendin (9-39) during standardized oral glucose tolerance test (OGTT).

Placebo

IV infusion of normal saline

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

IV infusion of Placebo (normal saline) during standardized oral glucose tolerance test (OGTT)

Interventions

Exendin (9-39)

IV infusion of Exendin (9-39) during standardized oral glucose tolerance test (OGTT).

Intervention Type: DRUG

Placebo

IV infusion of Placebo (normal saline) during standardized oral glucose tolerance test (OGTT)

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tracey McLaughlin

OTHER

Sponsor Role: lead

Responsible Party

Tracey McLaughlin

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Colleen Craig, M.D.

Role: STUDY_DIRECTOR

Stanford University

Locations

Stanford University School of Medicine

Stanford, California, United States

Countries

United States

References

Craig CM, Liu LF, Deacon CF, Holst JJ, McLaughlin TL. Critical role for GLP-1 in symptomatic post-bariatric hypoglycaemia. Diabetologia. 2017 Mar;60(3):531-540. doi: 10.1007/s00125-016-4179-x. Epub 2016 Dec 14.

Reference Type: DERIVED

PMID: 27975209 (View on PubMed)

Other Identifiers

29010

Identifier Type: -

Identifier Source: org_study_id