Morbid ObesityNCT00852553
Neurohumoral Control of Intestinal Electrical and Mechanical Activity
An observational study of Morbid Obesity, run by University of California, Davis at 2 sites in United States.
Trial summary
A collaborative research project with Dr. Kathleen Keef (Department of Physiology, University of Nevada School of Medicine, Reno, Nevada) studying the role of putative neurotransmitters in human intestine. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Morbid Obesity
- How many people
- 45 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2003to Feb 2012
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients having elective bowel resections
Who may be able to join
- All patients having elective bowel resection
Who cannot join
- Entire resected segment required for pathology
- Ischemic/necrotic disease
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Nevada School of Medicine
Reno, Nevada, 89557
University of California, Davis Medical Center
Sacramento, California, 95817
About this study
A collaborative research project with Dr. Kathleen Keef (Department of Physiology, University of Nevada School of Medicine, Reno, Nevada) studying the role of putative neurotransmitters in human intestine.
Read the detailed description
Segments of intestine from patients undergoing elective gastric bypass for morbid obesity or resections for non-obstructive neoplasms at the UC Davis Medical Center will be used. Samples will be taken from tissue normally removed and sent to Pathology or discarded. Full thickness segments of intestine (10 mm x 1 mm) will be prepared for recording either intracellular electrical activity or mechanical contraction. The effects of putative non-adrenergic, non-cholinergic neurotransmitters (e.g., nitric oxide) will be studied. The source of the tissue will not be identified either directly or indirectly through identifiers associated with the measured responses.
- Conditions
- Morbid Obesity
- Keywords
- intestinal, smooth, muscle, GI, motility
- Medical subject headings
- Obesity, Morbid
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2009 (estimated)
- Study startFeb 2003
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neal W. Fleming, M.D., Ph.D., Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00852553
- Sponsor's protocol ID
- 200311379
- Other IDs
- 200311379-8
- Status last verified
- May 2017
- First submitted
- 26 Feb 2009
- Last updated
- 30 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurohumoral Control of Intestinal Electrical and Mechanical Activity
- ClinicalTrials.gov ID
- NCT00852553
- Acronym / sponsor ID
- 200311379
- Conditions
- Morbid Obesity
- Keywords
- intestinal, smooth, muscle, GI, motility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Feb 2003
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 27 Feb 2009 (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.
A collaborative research project with Dr. Kathleen Keef (Department of Physiology, University of Nevada School of Medicine, Reno, Nevada) studying the role of putative neurotransmitters in human intestine.
Detailed description
Segments of intestine from patients undergoing elective gastric bypass for morbid obesity or resections for non-obstructive neoplasms at the UC Davis Medical Center will be used. Samples will be taken from tissue normally removed and sent to Pathology or discarded. Full thickness segments of intestine (10 mm x 1 mm) will be prepared for recording either intracellular electrical activity or mechanical contraction. The effects of putative non-adrenergic, non-cholinergic neurotransmitters (e.g., nitric oxide) will be studied. The source of the tissue will not be identified either directly or indirectly through identifiers associated with the measured responses.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients having elective bowel resections
Key inclusion criteria (1 listed)
- All patients having elective bowel resection
Key exclusion criteria (2 listed)
- Entire resected segment required for pathology
- Ischemic/necrotic disease
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
Not reported in the source record.
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 30 May 2017.
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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.
Neal W. Fleming, M.D., Ph.D. principal investigator
Professor
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Morbid Obesity, run by University of California, Davis at 2 sites 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 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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 30 May 2017.