Ignite Creation Date:
2024-05-05 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00510744
Status:
COMPLETED
Last Update Posted:
2016-06-02
First Post:
2007-08-01
Brief Title:
Pancreatic Enzymes to Restore Digestive Function in Malnourished Gastric Bypass Patients
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Pancreatic Enzymes to Restore Digestive Function in Malnourished Gastric Bypass Patients
Status:
COMPLETED
Status Verified Date:
2016-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
Obesity has reached epidemic proportions in the USA and Europe and is increasing world-wide Morbid obesity BMI40kgm2 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 23 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None