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

NCT02550145 | Terminated Phase 1 DMC

• 1 other identifier: 29010
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypoglycemia

Keywords

Hyperinsulinemic; post-bariatric surgery

Outcome Measures

Primary Outcomes (1)

• Plasma glucose area under the curve

  0 to 180 minutes

Secondary Outcomes (1)

• Plasma insulin area under the curve

  0 to 180 minutes

Other Outcomes (1)

• Hypoglycemia symptom score

  0-180 minutes

Study Arms (2)

Exendin(9-39)

EXPERIMENTAL

IV infusion of Exendin (9-39).

Drug: Exendin (9-39)

Placebo

PLACEBO COMPARATOR

IV infusion of normal saline

Other: Placebo

Interventions

Exendin (9-39) DRUG

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

Exendin(9-39)

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tracey McLaughlin: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related Publications (1)

• 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.

  PMID: 27975209 DERIVED

MeSH Terms

Conditions

Hypoglycemia

Interventions

exendin (9-39)

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Colleen Craig, M.D.

  Stanford University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 5, 2015
• First Posted: September 15, 2015
• Study Start: February 1, 2014
• Primary Completion: December 1, 2016
• Last Updated: December 4, 2024

Record last verified: 2024-12

Locations

US (1)