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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE June 5, 2015
First Posted Date  ICMJE September 15, 2015
Last Update Posted Date July 4, 2016
Study Start Date  ICMJE February 2014
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 14, 2015)
Plasma glucose area under the curve [ Time Frame: 0 to 180 minutes ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02550145 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2015)
Plasma insulin area under the curve [ Time Frame: 0 to 180 minutes ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 14, 2015)
Hypoglycemia symptom score [ Time Frame: 0-180 minutes ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Role of GLP-1 in Hyperinsulinemic Hypoglycemia Post-bariatric Surgery
Official Title  ICMJE The Role of GLP-1 in Mediating Glucose Reductions After Bariatric Surgery
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Hypoglycemia
Intervention  ICMJE
  • 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)
Study Arms  ICMJE
  • Experimental: Exendin(9-39)
    IV infusion of Exendin (9-39).
    Intervention: Drug: Exendin (9-39)
  • Placebo Comparator: Placebo
    IV infusion of normal saline
    Intervention: Other: Placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 14, 2015)
30
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02550145
Other Study ID Numbers  ICMJE 29010
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tracey McLaughlin, Stanford University
Study Sponsor  ICMJE Tracey McLaughlin
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Colleen Craig, M.D. Stanford University
PRS Account Stanford University
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP