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Pancreatic Enzymes to Restore Digestive Function in Malnourished Gastric Bypass Patients

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
pancreatic enzyme supplement
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring obesity, bariatric surgery, pancreatic secretion

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Male or female adults >18yrs
  2. h/o Roux-en-Y gastric bypass procedure
  3. Pre-surgery BMI >40Kg/m2
  4. Weight loss of >30%, or 100lbs in 1st year following bypass surgery
  5. Able to consume normal requirement levels of food. This will be determined from history (see above) and confirmed during the 72h food-balance study in the GCRC.

Exclusion Criteria:

  1. Chronic pancreatic disease as evidenced by history, pancreatic imaging (CT or MRP scanning or ERCP) or alcohol abuse (>3 units of alcohol/day) as documented by family or care givers
  2. h/o intestinal resection other than gastric bypass
  3. Unstable cardio-respiratory status (BP diastolic >100mmHg, systolic >200 or <80 mmHg), ambient pO2 <90%
  4. Presence of chronic inflammatory bowel or chronic small intestinal mucosal disease confirmed by radiology and biopsy.
  5. Current history of feeding disorder, such as bulimia nervosa. This will be excluded by the interview and attestation of spouses, close relatives, or home companions
  6. Pregnant women

Sites / Locations

  • University of Pittsburgh GCRC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

pancreatic enzyme supplementation

Arm Description

3 month supplementation in those gastric bypass patients shown to have a fat absorption less than 80%

Outcomes

Primary Outcome Measures

Fat Absorption
72 hour fat absorption study

Secondary Outcome Measures

Full Information

First Posted
August 1, 2007
Last Updated
April 26, 2016
Sponsor
University of Pittsburgh
Collaborators
Solvay Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00510744
Brief Title
Pancreatic Enzymes to Restore Digestive Function in Malnourished Gastric Bypass Patients
Official Title
Pancreatic Enzymes to Restore Digestive Function in Malnourished Gastric Bypass Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
Solvay Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Hypothesis: Bypass of the upper GI tract with bariatric surgery results in suppression of pancreatic function resulting in maldigestion and further malabsorption. In this study we will measure pancreatic secretion in previously obese gastric bypass patients with excessive weight loss. If malabsorption is associated with diminished pancreatic secretion, we will test over a 3 month period whether supplementation with enzyme supplements prevent further weight loss.
Detailed Description
Obesity has reached epidemic proportions in the USA and Europe, and is increasing world-wide. Morbid obesity (BMI>40kg/m2) is usually resistant to medical and dietary therapy while surgical treatment results in a permanent loss of most of the excess weight. The most popular technique today is the Roux-en-Y gastric bypass procedure which results in a weight loss of approximately 95 lbs per year or a 2/3 loss of the excess weight in 2 years (7-9). Weight loss occurs for 2 reasons: first the volume of the stomach is reduced, and second, the duodenum and first part of the jejunum is bypassed resulting in malabsorption. Although most patients tolerate the procedure well with a leveling off of weight loss close to the ideal body weight, a subpopulation of patients continue to lose weight, becoming progressively more malnourished, necessitating reversal of the surgery. To date, no studies have investigated what happens to pancreatic function in obese patients following bypass surgery, but from an understanding of the physiology of pancreatic stimulation, it is likely that the pancreas atrophies because the intestinal phase of pancreatic stimulation is bypassed and the inhibitory ileal brake is perpetually stimulated. In the following study we plan to investigate whether patients with excessive weight loss after bypass surgery develop malabsorption not only due to bypass of the upper GI tract but also because of impaired pancreatic enzyme secretion resulting from chronic activation of the ileal brake mechanism. Up to 20 post-bariatric surgery (Roux-en-Y) patients with excessive and continued weight loss will be screened for fat absorption and loss of pancreatic secretion. Those with loss of >20% fat absorption will then be treated at home with pancreatic enzyme supplements for a 3 month period to assess weight stabilization or gain. After 3 months, fat absorption and the pancreatic stimulation test will be repeated while patients are on enzyme supplementation to determine whether fat digestion and absorption has improved from baseline.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
obesity, bariatric surgery, pancreatic secretion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
pancreatic enzyme supplementation
Arm Type
Experimental
Arm Description
3 month supplementation in those gastric bypass patients shown to have a fat absorption less than 80%
Intervention Type
Drug
Intervention Name(s)
pancreatic enzyme supplement
Other Intervention Name(s)
Creon
Intervention Description
4 caps with meals, 2 with snacks
Primary Outcome Measure Information:
Title
Fat Absorption
Description
72 hour fat absorption study
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female adults >18yrs h/o Roux-en-Y gastric bypass procedure Pre-surgery BMI >40Kg/m2 Weight loss of >30%, or 100lbs in 1st year following bypass surgery Able to consume normal requirement levels of food. This will be determined from history (see above) and confirmed during the 72h food-balance study in the GCRC. Exclusion Criteria: Chronic pancreatic disease as evidenced by history, pancreatic imaging (CT or MRP scanning or ERCP) or alcohol abuse (>3 units of alcohol/day) as documented by family or care givers h/o intestinal resection other than gastric bypass Unstable cardio-respiratory status (BP diastolic >100mmHg, systolic >200 or <80 mmHg), ambient pO2 <90% Presence of chronic inflammatory bowel or chronic small intestinal mucosal disease confirmed by radiology and biopsy. Current history of feeding disorder, such as bulimia nervosa. This will be excluded by the interview and attestation of spouses, close relatives, or home companions Pregnant women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen J O'Keefe, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh GCRC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
with publication

Learn more about this trial

Pancreatic Enzymes to Restore Digestive Function in Malnourished Gastric Bypass Patients

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