drugset / Trial / NCT02733848

CREON for the Treatment of Post-RYGB Hypoglycemia

NCT02733848

Phase 1 Terminated 5 enrolled East Carolina University
Non-randomizedCrossoverSingle-blindTreatment

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.

Timeline

Start
2014-02
Primary completion
2018-01-31
Completion
2018-01-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Pancrelipase Protein / enzyme biologic 500 iu/kg

Indications