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

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ClinicalTrials.gov Identifier: NCT02550145
Recruitment Status : Unknown
Verified April 2016 by Tracey McLaughlin, Stanford University.
Recruitment status was:  Recruiting
First Posted : September 15, 2015
Last Update Posted : July 4, 2016
Sponsor:
Information provided by (Responsible Party):
Tracey McLaughlin, Stanford University

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.

Condition or disease Intervention/treatment Phase
Hypoglycemia Drug: Exendin (9-39) Other: Placebo Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Role of GLP-1 in Mediating Glucose Reductions After Bariatric Surgery
Study Start Date : February 2014
Estimated Primary Completion Date : December 2016


Arm Intervention/treatment
Experimental: Exendin(9-39)
IV infusion of Exendin (9-39).
Drug: Exendin (9-39)
IV infusion of Exendin (9-39) during standardized oral glucose tolerance test (OGTT).

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




Primary Outcome Measures :
  1. Plasma glucose area under the curve [ Time Frame: 0 to 180 minutes ]

Secondary Outcome Measures :
  1. Plasma insulin area under the curve [ Time Frame: 0 to 180 minutes ]

Other Outcome Measures:
  1. Hypoglycemia symptom score [ Time Frame: 0-180 minutes ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02550145


Contacts
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Contact: Colleen Craig, M.D. 650-736-2056 cmcraig@stanford.edu
Contact: Tracey McLaughlin, M.D.

Locations
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United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Colleen Craig, M.D.    650-350-2153    cmcraig@stanford.edu   
Sponsors and Collaborators
Tracey McLaughlin
Investigators
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Study Director: Colleen Craig, M.D. Stanford University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Tracey McLaughlin, Associate Professor, Stanford University
ClinicalTrials.gov Identifier: NCT02550145     History of Changes
Other Study ID Numbers: 29010
First Posted: September 15, 2015    Key Record Dates
Last Update Posted: July 4, 2016
Last Verified: April 2016

Keywords provided by Tracey McLaughlin, Stanford University:
Hyperinsulinemic
post-bariatric surgery

Additional relevant MeSH terms:
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Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases