N/A N=5 Treatment

Pancreatic Enzymes to Restore Digestive Function in Malnourished Gastric Bypass Patients

Obesity

Bottom Line

View on ClinicalTrials.gov: NCT00510744 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2016

Primary outcome: Primary: Fat Absorption — 60.6 g/d — p=<0.05

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: pancreatic enzyme supplement (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Pittsburgh
Primary completion: Jul 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Fat Absorption	60.6	<0.05 sig

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.

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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

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Data sourced from ClinicalTrials.gov (NCT00510744). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.