Pancreatic Enzymes to Restore Digestive Function in Malnourished Gastric Bypass Patients

• Sponsor: University of Pittsburgh (Other)
• Overall Status: Completed
• CT.gov ID: NCT00510744
• Collaborator: Solvay Pharmaceuticals (Industry)
• Enrollment: 5
• Location: 1
• Arm: 1
• Duration (Months): 96
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Drug: pancreatic enzyme supplement	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 5 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Pancreatic Enzymes to Restore Digestive Function in Malnourished Gastric Bypass Patients
• Study Start Date: Aug 1, 2007
• Actual Primary Completion Date: Jul 1, 2015
• Actual Study Completion Date: Aug 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: pancreatic enzyme supplementation 3 month supplementation in those gastric bypass patients shown to have a fat absorption less than 80%	Drug: pancreatic enzyme supplement; 4 caps with meals, 2 with snacks; Other Names: Creon

Outcome Measures

Primary Outcome Measures

1. Fat Absorption [3 months]

   72 hour fat absorption study

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pittsburgh GCRC	Pittsburgh	Pennsylvania	United States	15213

Sponsors and Collaborators

• University of Pittsburgh
• Solvay Pharmaceuticals

Investigators

• Principal Investigator: Stephen J O'Keefe, MD, University of Pittsburgh

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Stephen O'Keefe, Professor of Medicine, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT00510744
• Other Study ID Numbers: PRO07070305
• First Posted: Aug 2, 2007
• Last Update Posted: Jun 2, 2016
• Last Verified: Apr 1, 2016

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Stephen O'Keefe, Professor of Medicine, University of Pittsburgh: obesity, bariatric surgery, pancreatic secretion
• Additional relevant MeSH terms: Obesity; Malnutrition

Study Results

Participant Flow

Arm/Group Title	Pancreatic Enzyme Supplementation
Arm/Group Description	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
Period Title: Overall Study
STARTED	5
COMPLETED	5
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Pancreatic Enzyme Supplementation
Arm/Group Description	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
Overall Participants	5
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	5 100%
>=65 years	0 0%
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	49
Sex: Female, Male (Count of Participants)
Female	4 80%
Male	1 20%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	1 20%
White	4 80%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	5 100%

Outcome Measures

1. Primary Outcome

Title	Fat Absorption
Description	72 hour fat absorption study
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

each patients as their own control, baseline fat absorption vs post 3 month enzyme supplementation fat absorption

Arm/Group Title	Pancreatic Enzyme Supplementation
Arm/Group Description	3 month supplementation in those gastric bypass patients shown to have a fat absorption less than 80% The ability of pancreatic enzyme supplement: 4 caps with meals, 2 with snacks to improve fat absorption
Measure Participants	5
Mean (Standard Error) [g/d]	60.6 (13.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pancreatic Enzyme Supplementation
	Comments	paired changes in fat absorption assessed by parametric (t test) or non-parametric tests (Mann-Whitney)
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.2
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 24
	Estimation Comments

Adverse Events

Time Frame	3 months
Arm/Group Title	Pancreatic Enzyme Supplementation
Arm/Group Description	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
All Cause Mortality
	Pancreatic Enzyme Supplementation
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Pancreatic Enzyme Supplementation
	Affected / at Risk (%)	# Events
Total	0/5 (0%)
Other (Not Including Serious) Adverse Events
	Pancreatic Enzyme Supplementation
	Affected / at Risk (%)	# Events
Total	0/5 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.