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CREON for the Treatment of Post-RYGB Hypoglycemia

Primary Purpose

Hypoglycemia

Status
Terminated
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Creon
Diet
Placebo
Sponsored by
East Carolina University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypoglycemia focused on measuring Roux-en-Y gastric bypass, Hypoglycemia, Creon

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Placebo Comparator

    Arm Label

    DIET

    Creon

    Placebo

    Arm Description

    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.

    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.

    Subjects will be provided placebo and advised to take it with meals and snacks to provide.

    Outcomes

    Primary Outcome Measures

    Frequency of Hypoglycemia
    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

    Continuous Glucose Monitoring using the Medtronic iPro 2
    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.

    Full Information

    First Posted
    February 15, 2016
    Last Updated
    January 31, 2018
    Sponsor
    East Carolina University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02733848
    Brief Title
    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

    2. Study Status

    Record Verification Date
    January 2018
    Overall Recruitment Status
    Terminated
    Why Stopped
    Lack of funding
    Study Start Date
    February 2014 (undefined)
    Primary Completion Date
    January 31, 2018 (Actual)
    Study Completion Date
    January 31, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    East Carolina University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypoglycemia
    Keywords
    Roux-en-Y gastric bypass, Hypoglycemia, Creon

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Crossover Assignment
    Masking
    Participant
    Allocation
    Non-Randomized
    Enrollment
    5 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    DIET
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Creon
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Subjects will be provided placebo and advised to take it with meals and snacks to provide.
    Intervention Type
    Drug
    Intervention Name(s)
    Creon
    Intervention Description
    Creon is a porcine derived pancreatic enzyme supplement that comes in in fixed dose combinations of lipase, protease, and amylase, respectively. Dosing is based on lipase per kilograms per meal (i.e. lipase units/kg/meal). Subjects will be started at a dose of 500 units of lipase/kg/meal and snacks at week 4 and continued until week 8. A follow-up visit at week 6 will assess patient for tolerance to Creon and need for dosage adjustment. Formulations come in different fixed dose combinations as follows: Creon: Lipase 3000 USP units, protease 9500 USP units, and amylase 15,000 USP units Creon: Lipase 6000 USP units, protease 19,000 USP units, and amylase 30,000 USP units Creon: Lipase 12,000 USP units, protease 38,000 USP units, and amylase 60,000 USP units Creon: Lipase 24,000 USP units, protease 76,000 USP units, and amylase 120,000 USP units Creon: Lipase 36,000 USP units, protease 114,000 USP units, and amylase 180,000 USP units
    Intervention Type
    Other
    Intervention Name(s)
    Diet
    Intervention Description
    A registered dietician will meet with the subject and take a thorough review of the patient's dietary history. The subject will then be counseled on a lower carbohydrate and higher protein diet. This diet will be continued for the entire 12 week of the study. The registered dietician will reinforce dietary recommendations by phone on week 2, 4 and 8, respectively.
    Intervention Type
    Other
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo will be given to the patient in single blind fashion with the subject unaware but PI aware of study drug assignment from week 8-12. Placebo tablets will be given with meals and snacks similar to CREON to maintain patient blinding to study drug assignment. A follow-up visit on week 10 to review patient tolerance, side effects and possible drug adjustment.
    Primary Outcome Measure Information:
    Title
    Frequency of Hypoglycemia
    Description
    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.
    Time Frame
    2 years
    Secondary Outcome Measure Information:
    Title
    Continuous Glucose Monitoring using the Medtronic iPro 2
    Description
    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.
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Moahad S Dar, MD
    Organizational Affiliation
    Brody School of Medicine at East Carolina University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    Citations:
    PubMed Identifier
    24737312
    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.
    Results Reference
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    CREON for the Treatment of Post-RYGB Hypoglycemia

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