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

Tracey McLaughlin

Status and phase: Terminated; Phase 1

Conditions: Hypoglycemia

Treatments: Other: Placebo; Drug: Exendin (9-39)

Study type: Interventional

Funder types: Other

Identifiers

NCT02550145

29010

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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10 participants in 2 patient groups, including a placebo group

Exendin(9-39)

Experimental group

Description:

IV infusion of Exendin (9-39).

Treatment:

Drug: Exendin (9-39)

Placebo

Placebo Comparator group

Description:

IV infusion of normal saline

Treatment:

Other: Placebo