CREON for the Treatment of Post-RYGB Hypoglycemia

Phase 1

Terminated

• Conditions: Hypoglycemia
• Interventions: Other: Diet; Other: Placebo; Drug: Creon

• Registration Number: NCT02733848
• Lead Sponsor: East Carolina University

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.

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2016-02-15
• Study First Submitted QC: 2016-04-05
• Study First Posted: 2016-04-12
• Primary Completion: 2018-01-31
• Study Completion: 2018-01-31
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-25
• Last Update Posted: 2023-10-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
DIET	Diet	A registered dietician (RD) will meet with and thoroughly review the patients diet. The patient will be counseled on a diet lower in refined carbohydrates and higher in protein.
Placebo	Placebo	Subjects will be provided placebo and advised to take it with meals and snacks to provide.
Creon	Creon	Subjects will be provided Creon at a dose of 500 units/kg of lipase to be taken with meals and snacks to see if this decreases frequency and severity of hypoglycemia.

Primary Outcome Measures

Name	Time	Method
Frequency of Hypoglycemia	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.

Secondary Outcome Measures

Name	Time	Method
Continuous Glucose Monitoring using the Medtronic iPro 2	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.