Pancreatic Enzymes to Restore Digestive Function in Malnourished Gastric Bypass Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by University of Pittsburgh.
Recruitment status was  Recruiting
Solvay Pharmaceuticals
Information provided by:
University of Pittsburgh Identifier:
First received: August 1, 2007
Last updated: February 12, 2009
Last verified: February 2009
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 Intervention
Drug: Creon

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pancreatic Enzymes to Restore Digestive Function in Malnourished Gastric Bypass Patients

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Control of excessive weight loss [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • pancreatic secretion [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: August 2007
Estimated Study Completion Date: August 2009
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Creon
    4 caps with meals, 2 with snacks
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.

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00510744

Contact: Stephen J O'Keefe, MD 412 648 7217

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

Responsible Party: Stephen O'Keefe, MD, University of Pittsburgh Identifier: NCT00510744     History of Changes
Other Study ID Numbers: PRO07070305 
Study First Received: August 1, 2007
Last Updated: February 12, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Pittsburgh:
obesity, bariatric surgery, pancreatic secretion processed this record on May 25, 2016