Obesity
Conditions
Keywords
obesity, bariatric surgery, pancreatic secretion
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 (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.
Interventions
DRUGpancreatic enzyme supplement
4 caps with meals, 2 with snacks
Sponsors
Solvay Pharmaceuticals
University of Pittsburgh
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female adults \>18yrs 2. h/o Roux-en-Y gastric bypass procedure 3. Pre-surgery BMI \>40Kg/m2 4. Weight loss of \>30%, or 100lbs in 1st year following bypass surgery 5. 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
1. 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 2. h/o intestinal resection other than gastric bypass 3. Unstable cardio-respiratory status (BP diastolic \>100mmHg, systolic \>200 or \<80 mmHg), ambient pO2 \<90% 4. Presence of chronic inflammatory bowel or chronic small intestinal mucosal disease confirmed by radiology and biopsy. 5. 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 6. Pregnant women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fat Absorption | 3 months | 72 hour fat absorption study |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pancreatic Enzyme Supplementation 3 month supplementation in those gastric bypass patients shown to have a fat absorption less than 80%
pancreatic enzyme supplement: 4 caps with meals, 2 with snacks | 5 |
| Total | 5 |
Baseline characteristics
| Characteristic | Pancreatic Enzyme Supplementation |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants |
| Age, Continuous | 49 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 4 Participants |
| Region of Enrollment United States | 5 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
Primary
Fat Absorption
72 hour fat absorption study
Time frame: 3 months
Population: each patients as their own control, baseline fat absorption vs post 3 month enzyme supplementation fat absorption
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pancreatic Enzyme Supplementation | Fat Absorption | 60.6 g/d | Standard Error 13.4 |
Comparison: paired changes in fat absorption assessed by parametric (t test) or non-parametric tests (Mann-Whitney)p-value: <0.05t-test, 2 sided