Clinical Trial: CREON for the Treatment of Post-RYGB Hypoglycemia

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Proof-of-Concept Study Using Pancreatic Enzyme Replacement for the Treatment of Post-Roux-en-Y Gastric Bypass Hypoglycemia

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 Summary:

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.


Sponsor: East Carolina University

Current Primary Outcome: Frequency of Hypoglycemia [ Time Frame: 2 years ]

The effect of DIET, CREON and PLACEBO on the number of hypoglycemic events (i.e. <70 mg/dl) will be assessed using a standard blood glucose monitor that measures glucose in venous blood.


Original Primary Outcome: Same as current

Current Secondary Outcome: Continuous Glucose Monitoring using the Medtronic iPro 2 [ Time Frame: 2 years ]

The effect of DIET, CREON and PLACEBO on the percent of time iPro 2 glucose values are less than 70 mg/dL will be measured.


Original Secondary Outcome: Same as current

Information By: East Carolina University

Dates:
Date Received: February 15, 2016
Date Started: February 2014
Date Completion: April 2017
Last Updated: April 13, 2016
Last Verified: April 2016