Obesity, MorbidNCT03279653
Pancreatic Exocrine Insufficiency After Bariatric Surgery
An observational study of Obesity, Morbid and Pancreatic Insufficiency, run by Umraniye Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Main proposed benefit of sleeve gastrectomy is loss of ghrelin secreting tissue. Some studies express that ghrelin augment pancreatic regeneration. Therefore we hypothesized that with sleeve gastrectomy it may result with pancreatic insufficiency. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Morbid, Pancreatic Insufficiency
- What is being tested?
- SleeveGastrectomy
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2017to 1 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are eligible for bariatric surgery with NIH criteria and American Society of Anesthesiologists (ASA)-Physical Status Classification System.
Who may be able to join
- Patients underwent bariatric surgery (Sleeve gastrectomy) after concordonce with NIH criteria
Who cannot join
- Additional operations to sleeve gastrectomy like duodenal switch. Other bariatric operations.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Umraniye Education and Research Hospital
Istanbul, Ümraniye, 34000
Fatih Basak, 5055034571, fatihbasak@gmail.com
About this study
Official title: Effect of Sleeve Gastrectomy on Pancreatic Exocrine Insufficiency.
Main proposed benefit of sleeve gastrectomy is loss of ghrelin secreting tissue. Some studies express that ghrelin augment pancreatic regeneration. Therefore we hypothesized that with sleeve gastrectomy it may result with pancreatic insufficiency.
Read the detailed description
Mechanism of weight loss differs in bariatric surgery according to type of surgery.
With sleeve gastrectomy which has restrictive mechanism, ghrelin excretion decreases, and this condition is attributed as an additional mechanism in weight loss.
Ghrelin effects pancreatic regeneration, and loss of ghrelin may result with pancreatic insufficiency. Therefore we aimed to deteremine this association.
- Conditions
- Obesity, Morbid, Pancreatic Insufficiency
- Being tested
- SleeveGastrectomy
- Medical subject headings
- Obesity, Morbid, Exocrine Pancreatic Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SleeveGastrectomyProcedure or surgery
Preoperative enzyme test before and after sleeve gastrectomy. Sleeve Gastrectomy will be performed. Preoperative (in one month) and Postoperative (after 3 months) pancreatic enzyme sufficiency (with steatocrit or fecal elastase) will be compared.
| Study group | Role | What they receive |
|---|---|---|
| SleeveGastrectomy | Sleeve Gastrectomy will be performed. Preoperative and Postoperative pancreatic enzyme sufficiency (with steatocrit or fecal elastase) will be compared. Receives: Procedure: SleeveGastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pancreatic excorine enzyme difference
Effect of operation on pancreatic excorine enzyme
Measured: post operative 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2017
- Study start1 Sep 2017
- Primary completion1 Sep 2018 (estimated)
- Study completion1 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, MorbidStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Umraniye Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Fatih Basak, Umraniye Education and Research Hospital
- Investigators
- Fatih Basak, MD, Principal investigator, University of Health Science, Umraniye Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03279653
- Sponsor's protocol ID
- p-exocrine-insufficiency
- Status last verified
- Sep 2017
- First submitted
- 8 Sep 2017
- Last updated
- 13 Sep 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sleeve Gastrectomy on Pancreatic Exocrine Insufficiency.
- ClinicalTrials.gov ID
- NCT03279653
- Acronym / sponsor ID
- p-exocrine-insufficiency
- Conditions
- Obesity, Morbid, Pancreatic Insufficiency
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Umraniye Education and Research HospitalOther government
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 Sep 2018 (estimated)
- Study completion
- 1 Dec 2018 (estimated)
- First posted
- 12 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Main proposed benefit of sleeve gastrectomy is loss of ghrelin secreting tissue. Some studies express that ghrelin augment pancreatic regeneration. Therefore we hypothesized that with sleeve gastrectomy it may result with pancreatic insufficiency.
Detailed description
Mechanism of weight loss differs in bariatric surgery according to type of surgery.
With sleeve gastrectomy which has restrictive mechanism, ghrelin excretion decreases, and this condition is attributed as an additional mechanism in weight loss.
Ghrelin effects pancreatic regeneration, and loss of ghrelin may result with pancreatic insufficiency. Therefore we aimed to deteremine this association.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SleeveGastrectomy | – | Procedure: SleeveGastrectomySleeve Gastrectomy will be performed. Preoperative and Postoperative pancreatic enzyme sufficiency (with steatocrit or fecal elastase) will be compared. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are eligible for bariatric surgery with NIH criteria and American Society of Anesthesiologists (ASA)-Physical Status Classification System.
Key inclusion criteria (1 listed)
- Patients underwent bariatric surgery (Sleeve gastrectomy) after concordonce with NIH criteria
Key exclusion criteria (1 listed)
- Additional operations to sleeve gastrectomy like duodenal switch. Other bariatric operations.
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 |
|---|---|---|
| SleeveGastrectomyPreoperative enzyme test before and after sleeve gastrectomy. Sleeve Gastrectomy will be performed. Preoperative (in one month) and Postoperative (after 3 months) pancreatic enzyme sufficiency (with steatocrit or fecal elastase) will be compared. | Procedure or surgery | SleeveGastrectomy |
Primary outcome
Pancreatic excorine enzyme difference
Time frame: post operative 3 months
Effect of operation on pancreatic excorine enzyme
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2017.
- Individual participant dataSharing planned: No
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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.
Fatih Basak, MD principal investigator
University of Health Science, Umraniye Education and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, Morbid and Pancreatic Insufficiency, run by Umraniye Education and Research Hospital at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 13 Sep 2017. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fatih Basak, MD ((+0216 6321818, fatihbasak@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pancreatic excorine enzyme difference (time frame: post operative 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 13 Sep 2017; AzTrials last refreshed its copy on 2 Nov 2026.