CREON for the Treatment of Post-RYGB Hypoglycemia
This trial is active, not recruiting.
|Treatments||creon, diet, placebo|
|Sponsor||East Carolina University|
|Start date||February 2014|
|End date||April 2017|
|Trial size||5 participants|
|Trial identifier||NCT02733848, UMCIRB 11-001311|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||crossover assignment|
|Masking||single blind (subject)|
Frequency of Hypoglycemia
time frame: 2 years
Continuous Glucose Monitoring using the Medtronic iPro 2
time frame: 2 years
Male or female participants at least 18 years old.
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
|Official title||A Proof-of-Concept Study Using Pancreatic Enzyme Replacement for the Treatment of Post-Roux-en-Y Gastric Bypass Hypoglycemia|
|Principal investigator||Moahad S Dar, MD|
|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.|
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