Pancreatic Enzymes to Restore Digestive Function in Malnourished Gastric Bypass Patients

NCT00510744 | Completed Results DMC

• 1 other identifier: PRO07070305
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity

Keywords

obesity, bariatric surgery, pancreatic secretion

Outcome Measures

Primary Outcomes (1)

• Fat Absorption

  72 hour fat absorption study

  3 months

Study Arms (1)

pancreatic enzyme supplementation

EXPERIMENTAL

3 month supplementation in those gastric bypass patients shown to have a fat absorption less than 80%

Drug: pancreatic enzyme supplement

Interventions

pancreatic enzyme supplement DRUG

4 caps with meals, 2 with snacks

Also known as: Creon

pancreatic enzyme supplementation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Pittsburgh: lead
• Solvay Pharmaceuticals: collaborator

Study Sites (1)

University of Pittsburgh GCRC

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Pancrelipase

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lipase; Carboxylic Ester Hydrolases; Esterases; Hydrolases; Enzymes; Enzymes and Coenzymes; Pancreatic Extracts; Tissue Extracts; Complex Mixtures

Results Point of Contact

• Title: Stephen O'Keefe
• Organization: University of Pittsburgh

sjokeefe@pitt.edu

412 648 7217

Study Officials

• Stephen J O'Keefe, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: August 1, 2007
• First Posted: August 2, 2007
• Study Start: August 1, 2007
• Primary Completion: July 1, 2015
• Study Completion: August 1, 2015
• Last Updated: June 2, 2016
• Results First Posted: June 2, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)