Pancreatic Enzymes to Restore Digestive Function in Malnourished Gastric Bypass Patients

Completed · Not applicable

Conditions studied: Obesity

In brief

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.

Key facts

Study ID

NCT00510744

Run by

University of Pittsburgh

People needed

5

Starts

2007-08-01

Expected to finish

2015-08-01

Last updated by the study team

2016-06-02

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• University of Pittsburgh GCRC — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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