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Evaluating Exenatide for the Treatment of Postprandial Hyperinsulinemic Hypoglycemia

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ClinicalTrials.gov Identifier: NCT02685852
Recruitment Status : Completed
First Posted : February 19, 2016
Last Update Posted : July 22, 2019
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

Tracking Information
First Submitted Date  ICMJE January 19, 2016
First Posted Date  ICMJE February 19, 2016
Last Update Posted Date July 22, 2019
Study Start Date  ICMJE February 2016
Actual Primary Completion Date July 10, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 15, 2016)
  • Glucose area under the curve (AUC) following treatment for each 4-hour test period [ Time Frame: During the 4-hour test period ]
    Each time point (15, 30, 45, 60, 90, 120, 180 and 240 minutes) will be used to calculate AUC using the trapezoidal method.
  • Presence of hypoglycemia [ Time Frame: 15, 30, 45, 60, 90, 120, 180 and 240 minutes ]
    If at each time-point (15, 30, 45, 60, 90, 120, 180 and 240 minutes) plasma glucose is <60 mg/dL, participants will be defined as hypoglycemic
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02685852 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 15, 2016)
  • Minimum post-prandial blood sugar level (mg/dL) [ Time Frame: post meal test ]
    The lowest post-prandial blood glucose level at any time point (15, 30, 45, 60, 90, 120, 180 and 240 minutes) may be used as the minimum post-prandial blood sugar level (mg/dL).
  • Change in post-prandial blood glucose from 0min to 120min [ Time Frame: 0min to 120min ]
    % change in blood glucose 0min to 120min
  • Change in post-prandial Insulin levels (mcg/mL) [ Time Frame: 0min to 120min ]
    % change in insulin 0min to 120min
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluating Exenatide for the Treatment of Postprandial Hyperinsulinemic Hypoglycemia
Official Title  ICMJE A Pilot Study Evaluating Exenatide for the Treatment of Postprandial Hyperinsulinemic Hypoglycemia Post-RYGB
Brief Summary The purpose of the study is to evaluate the effectiveness of exenatide in adults experiencing episodes of hyperinsulinemic hypoglycemia following Roux-en-Y bariatric surgery.
Detailed Description

Roux-en-Y gastric bypass surgery (RYGB) is one of the most common bariatric surgeries in the United States and is generally highly effective for weight loss. Unfortunately, among the potential complications is hyperinsulinemic hypoglycemia. Though the prevalence of this disorder has not been fully characterized, it can be associated with debilitating symptoms which severely impact quality of life and can be life-threatening. The underlying pathophysiology of hyperinsulinemic hypoglycemia likely involves a mismatch in the amount of insulin secreted in response to mealtime carbohydrate absorption. It has been observed that the ingestion of a high carbohydrate load often leads to a modest rise in post-prandial glucose levels followed by an inappropriately exaggerated insulin release among individuals with this condition. Low carbohydrate diet sometimes provides full or partial relief of the symptoms.

Standard medical management for RYGB associated postprandial hyperinsulinemic hypoglycemia includes acarbose, which partially reduces carbohydrate absorption from the gut, and diazoxide, which directly inhibits insulin release from pancreatic beta cells. However, the medical options are not reliably effective, leading some individuals to reverse RYGB, which also may not be effective, or even undergo partial pancreatectomy, risking additional complications such as diabetes. Much more reliably effective treatments are needed for this special population who develop this bariatric surgical complication.

Potential mechanisms contributing to the mismatched insulin secretion post RYGB include decreased systemic and adipose tissue inflammation, and increased insulin receptor expression in liver and skeletal muscle, and increases in adiponectin.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hyperinsulinemic Hypoglycemia
Intervention  ICMJE
  • Drug: Exenatide
    Exenatide at a dose of 5 mcg
    Other Name: Byetta
  • Drug: Acarbose
    Acarbose at a dose of 25 mg
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Active Comparator: Arm 1: Exenatide (5mcg)
    Exenatide at a dose of 5 mcg
    Intervention: Drug: Exenatide
  • Active Comparator: Arm 2: Exenatide (5mcg) + Acarbose (25mg)
    Exenatide (5mcg) + Acarbose (25mg)
    Interventions:
    • Drug: Exenatide
    • Drug: Acarbose
  • Placebo Comparator: Arm 3: Placebo
    Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: July 10, 2019)
11
Original Estimated Enrollment  ICMJE
 (submitted: February 15, 2016)
12
Actual Study Completion Date  ICMJE July 10, 2019
Actual Primary Completion Date July 10, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. must have undergone RYGB and subsequently developed post-prandial hypoglycemia (defined as at least 3 episodes over a six-month period with documented capillary blood sugars [<60 mg/dL with hypoglycemic symptoms). Subjects may also have had a formal mixed meal tolerance test with post meal blood sugar <60 mg/dL.
  2. Subjects who otherwise meet the study criteria above with hypoglycemia symptoms but who do not have documented hypoglycemia by plasma measurement may undergo a screening visit to document the requisite levels for consideration into the study.

Exclusion Criteria:

  1. Chronic or acute diseases of the liver.
  2. Chronic or acute diseases of the pancreas (including type 1 diabetes or pancreatitis or a history of pancreatitis). Subjects may have a diagnosis of type 2 diabetes but must no longer require diabetes medication.
  3. Chronic or acute diseases of the kidneys.
  4. Known malignancies and must not have a family history of medullary thyroid cancer.
  5. History of pre-RYGB hypoglycemia symptoms or low documented plasma glucose preoperatively.
  6. Pregnant or plans to become pregnant throughout study duration
  7. Breastfeeding
  8. Medication exclusions in addition to the current use of diabetes medications. Subjects will be excluded if they have previously taken GLP-1 agonists.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
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 NCT02685852
Other Study ID Numbers  ICMJE 1503M65841
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Minnesota
Study Sponsor  ICMJE University of Minnesota
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Shalamar D Sibley, MD University of Minnesota
PRS Account University of Minnesota
Verification Date July 2019

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