Pancreatic Enzymes to Restore Digestive Function in Malnourished Gastric Bypass Patients
Condition: Obesity
MeSH terms: Malnutrition
Study type: Interventional

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 (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.
    

Intervention name(s): pancreatic enzyme supplement
Intervention type(s): Drug
Intervention description(s): 4 caps with meals, 2 with snacks
Other intervention name(s): Creon
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: obesity, bariatric surgery, pancreatic secretion