Pancreatic Enzymes to Restore Digestive Function in Malnourished Gastric Bypass Patients
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.
Description
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.
Study Design
Control: Uncontrolled, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Obesity
Intervention
Creon
Location
University of Pittsburgh GCRC
Pittsburgh
Pennsylvania
United States
15213
Status
Recruiting
Source
University of Pittsburgh
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00510744
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Obesity, Abdominal
A condition of having excess fat in the abdomen. Abdominal obesity is typically defined as waist circumferences of 40 inches or more in men and 35 inches or more in women. Abdominal obesity raises the risk of developing disorders, such as diabetes, hypertension and METABOLIC SYNDROME X.
Obesity, Morbid
The condition of weighing two, three, or more times the ideal weight, so called because it is associated with many serious and life-threatening disorders. In the BODY MASS INDEX, morbid obesity is defined as having a BMI greater than 40.0 kg/m2.
Anti-obesity Agents
Agents that increase energy expenditure and weight loss by neural and chemical regulation. Beta-adrenergic agents and serotoninergic drugs have been experimentally used in patients with non-insulin dependent diabetes mellitus (NIDDM) to treat obesity.
Obesity
A status with BODY WEIGHT that is grossly above the acceptable or desirable weight, usually due to accumulation of excess FATS in the body. The standards may vary with age, sex, genetic or cultural background. In the BODY MASS INDEX, a BMI greater than 30.0 kg/m2 is considered obese, and a BMI greater than 40.0 kg/m2 is considered morbidly obese (MORBID OBESITY).
Bariatric Medicine
The discipline concerned with WEIGHT REDUCTION in patients with OBESITY.
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