ObesityNCT02093416
Leptin Receptors in the Bariatric Surgical Population Within the University of Pittsburgh Medical System: A Cohort Study
An observational study of Obesity, run by University of Pittsburgh at 1 site in United States.
Trial summary
Prospective cohort study evaluating the role of leptin receptors in the bariatric surgical population compared with non obese controls. Additionally serum levels of leptin, ghrelin, motilin and PYY will be compared amongst the different BMI classes and a quality of life questionnaire completed by all participants. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Jul 2014
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Males and Females undergoing endoscopy
Who may be able to join
- Endoscopic Intervention
Who cannot join
- 18 years of age or older
- No acute GI bleeding
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh/UPMC Presby
Pittsburgh, Pennsylvania, 15213
About this study
Prospective cohort study evaluating the role of leptin receptors in the bariatric surgical population compared with non obese controls. Additionally serum levels of leptin, ghrelin, motilin and PYY will be compared amongst the different BMI classes and a quality of life questionnaire completed by all participants.
The hypothesis is that obese individuals have lower leptin receptors in enterocytes which is partially responsible for the higher serum leptin levels without appropriate control of satiety.
- Conditions
- Obesity
- Keywords
- Obesity, Leptin
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Control Group | BMI <30 There are 20 controls in this group | |
| Group 2 | BMI 30-35 There were 12 controls in this class | |
| Group 3 | BMI 35-40 There were 9 controls in this clas | |
| Group 4 | BMI >40 There were 9 controls in this class |
What is being measured
The primary outcome is the main question the study is designed to answer.
PCR test for Leptin Receptors
Endoscopic biopsies of enterocytes will be measured via PCR
Measured: 1 week
Secondary outcomes (2)
ELISA test for ghrelin, motilin, leptin and PYY
Blood samples collected to determine hormones via ELISA
Measured: 1 week
IWQOL lite questionnaire
Quality of Life questionnaire on obesity
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2014 (estimated)
- Study startOct 2013
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer L Seminerio, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02093416
- Sponsor's protocol ID
- PRO13010529
- Status last verified
- Jan 2016
- First submitted
- 18 Mar 2014
- Last updated
- 15 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leptin Receptors in the Bariatric Surgical Population Within the University of Pittsburgh Medical System: A Cohort Study
- ClinicalTrials.gov ID
- NCT02093416
- Acronym / sponsor ID
- PRO13010529
- Conditions
- Obesity
- Keywords
- Obesity, Leptin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 21 Mar 2014 (estimated)
- 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.
Prospective cohort study evaluating the role of leptin receptors in the bariatric surgical population compared with non obese controls. Additionally serum levels of leptin, ghrelin, motilin and PYY will be compared amongst the different BMI classes and a quality of life questionnaire completed by all participants.
The hypothesis is that obese individuals have lower leptin receptors in enterocytes which is partially responsible for the higher serum leptin levels without appropriate control of satiety.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1: Control Group | – | –BMI <30 There are 20 controls in this group |
| Group 2 | – | –BMI 30-35 There were 12 controls in this class |
| Group 3 | – | –BMI 35-40 There were 9 controls in this clas |
| Group 4 | – | –BMI >40 There were 9 controls in this class |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Males and Females undergoing endoscopy
Key inclusion criteria (1 listed)
- Endoscopic Intervention
Key exclusion criteria (2 listed)
- 18 years of age or older
- No acute GI bleeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
PCR test for Leptin Receptors
Time frame: 1 week
Endoscopic biopsies of enterocytes will be measured via PCR
2 secondary outcomes
ELISA test for ghrelin, motilin, leptin and PYY
Time frame: 1 week
IWQOL lite questionnaire
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2016.
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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.
Jennifer L Seminerio, 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?
An observational study of 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 1 inclusion and 2 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 15 Jan 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
PCR test for Leptin Receptors (time frame: 1 week). 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 15 Jan 2016.