Clinical trial NCT02733848: CREON for the Treatment of Post-RYGB Hypoglycemia
Official title: A Proof-of-Concept Study Using Pancreatic Enzyme Replacement for the Treatment of Post-Roux-en-Y Gastric Bypass Hypoglycemia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Hypoglycemia
Keywords: Roux-en-Y gastric bypass
Hypoglycemia
Creon
Lead sponsor: East Carolina University
Sponsor class: OTHER
First posted: 2016-04-12
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Hypoglycemia is an increasingly recognized complication of Roux-en-Y gastric bypass (RYGB) that is poorly understood and difficult to treat. Investigators hypothesize that after RYGB some patients have incomplete carbohydrate absorption in the small intestine which leads to inconsistent glucose levels and hypoglycemia during oral consumption of a meal. Investigators further hypothesize that pancreatic enzyme supplementation with (Creon) during meals and snacks will improve carbohydrate absorption and lead to more stable glucose levels in patients with post-RYGB hypoglycemia.

Detailed description: Primary Objective: Evaluate the feasibility and safety of Creon in the treatment of post-RYGB hypoglycemia as add-on therapy to a diet higher in protein and lower in carbohydrate.

Secondary Objective: Evaluate utility of continuous glucose monitoring (CGM) in monitoring hypoglycemia as an adjunct to standard venous blood testing using a glucometer in post-RYGB hypoglycemia.

Eligibility criteria: Inclusion Criteria:

* Males and females 18 years and older
* At least 6 months post-RYGB surgery
* Clinical history of post-surgical hypoglycemia evident by subjective symptoms (i.e. tachycardia, sweating, hunger, confusion) and glucose monitoring demonstrating a venous blood sugars \< 70 mg/dL
* Women must be postmenopausal, surgically sterile, not heterosexually active or heterosexually active using highly effective method of birth control
* Women of childbearing potential must have negative pregnancy test
* Subjects must have signed an informed consent document indicating they understand the purpose of and procedures required for the study and be willing to participate in the study
* Willing and able to adhere to restrictions and follow instructions specific to this study
* Adequate compliance in performing self-monitoring blood glucose (SMBG) testing at least three or more times per week and taking assigned medication dose as instructed

Exclusion Criteria:

* Current or past history of type 1 or type 2 diabetes
* Known hypersensitivity to Creon
* Known hypersensitivity to pork-derived products
* Liver function studies 2 times the upper limit of normal (ALT \& AST) and/or a GFR \< 90
* History of fibrosing colonic strictures
* History of gastroparesis, dysphagia, chronic abdominal pain, gastric outlet obstruction, chronic pancreatitis
* History of stomach, small intestine or colon surgery other than Roux-en-Y gastric bypass
* An active cancer of any type requiring concurrent treatment
* History of gout or hyperuricemia
* Current anemia requiring iron replacement
* Any clinically significant condition that in the opinion of the investigator would make participation not in the best interest or safety of the subject or could prevent limit or confound the specific endpoints assessments
* Not participating in any other research study
* Known history of drug or alcohol abuse within 6 months of screening visit
* Pregnancy or lactation (breastfeeding)
* Informed consent withdrawal by subject

Primary outcomes:
measure: Frequency of Hypoglycemia
timeFrame: 2 years
Secondary outcomes:
measure: Continuous Glucose Monitoring using the Medtronic iPro 2
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Brody School of Medicine at East Carolina University
name: Moahad S Dar, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sarwar H, Chapman WH 3rd, Pender JR, Ivanescu A, Drake AJ 3rd, Pories WJ, Dar MS. Hypoglycemia after Roux-en-Y gastric bypass: the BOLD experience. Obes Surg. 2014 Jul;24(7):1120-4. doi: 10.1007/s11695-014-1260-8. No abstract available.