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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02685852
Other study ID # 1503M65841
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date February 2016
Est. completion date July 22, 2019

Study information

Verified date April 2021
Source University of Minnesota
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 11
Est. completion date July 22, 2019
Est. primary completion date July 22, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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.

Study Design


Intervention

Drug:
Exenatide
Exenatide at a dose of 5 mcg
Acarbose
Acarbose at a dose of 25 mg
Exenatide Placebo
Placebo for Exenatide
Acarbose Placebo
Placebo for Acarbose

Locations

Country Name City State
United States University of Minnesota Medical Center Minneapolis Minnesota

Sponsors (1)

Lead Sponsor Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Glucose area under the curve (AUC) following treatment for each 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. During the 4-hour test period
Primary Presence of hypoglycemia 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 15, 30, 45, 60, 90, 120, 180 and 240 minutes
Secondary Minimum post-prandial blood sugar level (mg/dL) 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). post meal test
Secondary Change in post-prandial blood glucose from 0min to 120min % change in blood glucose 0min to 120min 0min to 120min
Secondary Change in post-prandial Insulin levels (mcg/mL) % change in insulin 0min to 120min 0min to 120min
See also
  Status Clinical Trial Phase
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Recruiting NCT05597475 - GLP1R-imaging in Post-RYGB Hypoglycemia N/A
Completed NCT03770637 - Glucagon Ready to Use (RTU) in Subjects With Hyperinsulinemic Hypoglycemia After Bariatric Surgery Phase 2
Completed NCT03103009 - Treatment Plan for an Individual Patient With Pasireotide for Hyperinsulinemic Hypoglycemia Phase 1
Completed NCT01933490 - Post-Gastric Bypass Hypoglycemia N/A
Completed NCT04836273 - Treatment of Post-bariatric Hypoglycaemia Phase 2
Recruiting NCT03930368 - Application of Raw Corn Starch on Patients With Insulinoma N/A