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

Hypoglycemia Clinical Trial

Official title:

The Role of GLP-1 in Mediating Glucose Reductions After Bariatric Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02550145
• Other study ID #: 29010
• Status: Recruiting
• Phase: Phase 1
• First received: June 5, 2015
• Last updated: July 1, 2016
• Start date: February 2014

Study information

• Verified date: April 2016
• Source: Stanford University
• Contact: Colleen Craig, M.D.
• Phone: 650-736-2056
• Email: cmcraig[@]stanford.edu
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypoglycemia

Intervention

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

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

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Tracey McLaughlin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hypoglycemia symptom score		0-180 minutes	No
Primary	Plasma glucose area under the curve		0 to 180 minutes	No
Secondary	Plasma insulin area under the curve		0 to 180 minutes	No