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Pancreatic Enzymes to Restore Digestive Function in Malnourished Gastric Bypass Patients
This study is currently recruiting participants.
Study NCT00510744   Information provided by University of Pittsburgh
First Received: August 1, 2007   Last Updated: February 12, 2009   History of Changes

August 1, 2007
February 12, 2009
August 2007
July 2009   (final data collection date for primary outcome measure)
Control of excessive weight loss [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Control of excessive weight loss [ Time Frame: 2 years ]
Complete list of historical versions of study NCT00510744 on ClinicalTrials.gov Archive Site
pancreatic secretion [ Time Frame: 2 years ] [ Designated as safety issue: No ]
pancreatic secretion [ Time Frame: 2 years ]
 
Pancreatic Enzymes to Restore Digestive Function in Malnourished Gastric Bypass Patients
Pancreatic Enzymes to Restore Digestive Function in Malnourished Gastric Bypass Patients

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.

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.

 
Interventional
Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Obesity
Drug: Creon
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
10
August 2009
July 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact: Stephen J O'Keefe, MD 412 648 7217 sjokeefe@pitt.edu
United States
 
NCT00510744
Stephen O'Keefe, MD, University of Pittsburgh
PRO07070305
University of Pittsburgh
Solvay Pharmaceuticals
Principal Investigator: Stephen J O'Keefe, MD University of Pittsburgh
University of Pittsburgh
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP