Pancreatic Enzymes to Restore Digestive Function in Malnourished Gastric Bypass Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00510744
Recruitment Status : Completed
First Posted : August 2, 2007
Results First Posted : June 2, 2016
Last Update Posted : June 2, 2016
Solvay Pharmaceuticals
Information provided by (Responsible Party):
Stephen O'Keefe, University of Pittsburgh

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.

Condition or disease Intervention/treatment Phase
Obesity Drug: pancreatic enzyme supplement Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pancreatic Enzymes to Restore Digestive Function in Malnourished Gastric Bypass Patients
Study Start Date : August 2007
Actual Primary Completion Date : July 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition
U.S. FDA Resources

Arm Intervention/treatment
Experimental: pancreatic enzyme supplementation
3 month supplementation in those gastric bypass patients shown to have a fat absorption less than 80%
Drug: pancreatic enzyme supplement
4 caps with meals, 2 with snacks
Other Name: Creon

Primary Outcome Measures :
  1. Fat Absorption [ Time Frame: 3 months ]
    72 hour fat absorption study

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00510744

United States, Pennsylvania
University of Pittsburgh GCRC
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Solvay Pharmaceuticals
Principal Investigator: Stephen J O'Keefe, MD University of Pittsburgh

Responsible Party: Stephen O'Keefe, Professor of Medicine, University of Pittsburgh Identifier: NCT00510744     History of Changes
Other Study ID Numbers: PRO07070305
First Posted: August 2, 2007    Key Record Dates
Results First Posted: June 2, 2016
Last Update Posted: June 2, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: with publication

Keywords provided by Stephen O'Keefe, University of Pittsburgh:
obesity, bariatric surgery, pancreatic secretion

Additional relevant MeSH terms:
Nutrition Disorders