ObesityNCT00510744
Pancreatic Enzymes to Restore Digestive Function in Malnourished Gastric Bypass Patients
A study testing pancreatic enzyme supplement in people with Obesity, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- pancreatic enzyme supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Aug 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female adults >18yrs
- h/o Roux-en-Y gastric bypass procedure
- Pre-surgery BMI >40Kg/m2
- Weight loss of >30%, or 100lbs in 1st year following bypass surgery
- 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.
Who cannot join
- 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
- h/o intestinal resection other than gastric bypass
- Unstable cardio-respiratory status (BP diastolic >100mmHg, systolic >200 or <80 mmHg), ambient pO2 <90%
- Presence of chronic inflammatory bowel or chronic small intestinal mucosal disease confirmed by radiology and biopsy.
- 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
- Pregnant women
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh GCRC
Pittsburgh, Pennsylvania, 15213
About this study
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.
Read the 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.
- Conditions
- Obesity
- Being tested
- pancreatic enzyme supplement
- Keywords
- obesity, bariatric surgery, pancreatic secretion
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pancreatic enzyme supplementDrug
Also called Creon
4 caps with meals, 2 with snacks
| Study group | Role | What they receive |
|---|---|---|
| pancreatic enzyme supplementation | Experimental | 3 month supplementation in those gastric bypass patients shown to have a fat absorption less than 80% Receives: Drug: pancreatic enzyme supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fat Absorption
72 hour fat absorption study
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2007 (estimated)
- Study startAug 2007
- Primary completionJul 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Solvay Pharmaceuticals
- Responsible party
- Principal investigator, Stephen O'Keefe, University of Pittsburgh
- Investigators
- Stephen J O'Keefe, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00510744
- Sponsor's protocol ID
- PRO07070305
- Status last verified
- Apr 2016
- First submitted
- 1 Aug 2007
- Last updated
- 2 Jun 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: with publication
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pancreatic Enzymes to Restore Digestive Function in Malnourished Gastric Bypass Patients
- ClinicalTrials.gov ID
- NCT00510744
- Acronym / sponsor ID
- PRO07070305
- Conditions
- Obesity
- Keywords
- obesity, bariatric surgery, pancreatic secretion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Solvay Pharmaceuticals
- Study start
- Aug 2007
- Primary completion
- Jul 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 2 Aug 2007 (estimated)
- Results
- Posted 2 Jun 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pancreatic enzyme supplementation | Experimental | Drug: pancreatic enzyme supplement3 month supplementation in those gastric bypass patients shown to have a fat absorption less than 80% |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female adults >18yrs
- h/o Roux-en-Y gastric bypass procedure
- Pre-surgery BMI >40Kg/m2
- Weight loss of >30%, or 100lbs in 1st year following bypass surgery
- 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.
Key exclusion criteria (6 listed)
- 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
- h/o intestinal resection other than gastric bypass
- Unstable cardio-respiratory status (BP diastolic >100mmHg, systolic >200 or <80 mmHg), ambient pO2 <90%
- Presence of chronic inflammatory bowel or chronic small intestinal mucosal disease confirmed by radiology and biopsy.
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pancreatic enzyme supplementAlso: Creon4 caps with meals, 2 with snacks | Drug | pancreatic enzyme supplementation |
Primary outcome
Fat Absorption
Time frame: 3 months
72 hour fat absorption study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. with publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen J O'Keefe, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pancreatic enzyme supplement in people with Obesity, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fat Absorption (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2016.