Stanford, California 94305


Purpose:

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.


Study summary:

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.


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.


NCT ID:

NCT02550145


Primary Contact:

Study Director
Colleen Craig, M.D.
Stanford University

Colleen Craig, M.D.
Phone: 650-736-2056
Email: cmcraig@stanford.edu


Backup Contact:

Tracey McLaughlin, M.D.


Location Contact:

Stanford, California 94305
United States

Colleen Craig, M.D.
Phone: 650-350-2153
Email: cmcraig@stanford.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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