View Clinical Trial (Medical Research Study)
Pancreatic Enzymes to Restore Digestive Function in Malnourished Gastric Bypass Patients
| City: |
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Pittsburgh |
| State: |
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Pennsylvania |
| Zip Code: |
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15213 |
| Conditions: |
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Obesity |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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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
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| NCT ID: |
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NCT00510744 |
| Primary Contact: |
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Principal Investigator
Stephen J O'Keefe, MD
University of Pittsburgh
Stephen J O'Keefe, MD
Phone: 412 648 7217
Email: sjokeefe@pitt.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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Pittsburgh, Pennsylvania 15213
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 17, 2013 |
| Modifications to this listing: |
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