ObesityNCT02036710
Location of GLP-1 Release
An observational study of Obesity, run by University of Minnesota at 1 site in United States.
Trial summary
Background: Physicians do not have a unified, scientifically tested theory of causation for obesity and its comorbidities, nor do they have explanations for the mechanics of the metabolic/bariatric surgery procedures. 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
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Oct 2013
- 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: Study population consisted of morbidly obese individuals who had decided to undergo open duodenal switch surgery
Who may be able to join
- Any patient who was qualified and approved for bariatric surgery and elected to undergo open duodenal switch procedure.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Location of Glucagon-Like Peptide (GLP)-1 Release
Background: Physicians do not have a unified, scientifically tested theory of causation for obesity and its comorbidities, nor do they have explanations for the mechanics of the metabolic/bariatric surgery procedures. Integral to proffered hypotheses are the actions of the hormones glucagon-like peptide (GLP-1), peptide YY (PYY), and leptin.
Study objective: To obtain blood levels of GLP-1, PYY, and leptin after stimulation of the terminal ileum and cecum by a static infusion of a food hydrolysate in morbidly obese patients undergoing a duodenal switch procedure.
Methods: Plasma levels of GLP-1, PYY, and leptin were obtained at 0, 30, 60, 90, and 120 minutes after instillation of 240 ml of a food hydrolysate into the ileum or cecum.
- Conditions
- Obesity
- Keywords
- GLP-1, PYY, Leptin, Duodenal Switch
- 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 |
|---|---|---|
| Cecum | Food hydrolysate instilled into terminal cecum of patient undergoing open duodenal switch procedure. Blood samples were then obtained at baseline and at 0, 30, 60, 90, and 120 minutes for analysis of circulating GLP-1, PYY, and leptin. | |
| Ileum | Food hydrolysate instilled into terminal ileum of patient undergoing open duodenal switch procedure. Blood samples were then obtained at baseline and at 0, 30, 60, 90, and 120 minutes for analysis of circulating GLP-1, PYY, and leptin. |
What is being measured
The primary outcome is the main question the study is designed to answer.
GLP-1
GLP- levels were measured at intervals over two hours after static bowel food hydrolysate was infused, in patients undergoing scheduled open duodenal switch procedure.
Measured: 2 hours
peptide YY (PYY)
PYY levels were measured at intervals over two hours after static bowel food hydrolysate was infused, in patients undergoing scheduled open duodenal switch procedure.
Measured: 2 hours
Leptin
Leptin levels were measured at intervals over two hours after static bowel food hydrolysate was infused, in patients undergoing scheduled open duodenal switch procedure.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2014 (estimated)
- Study startNov 2011
- Primary completionAug 2013
- Study completionOct 2013
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.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Henry Buchwald, MD, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02036710
- Sponsor's protocol ID
- 1104M97972
- Status last verified
- Oct 2019
- First submitted
- 10 Jan 2014
- Last updated
- 1 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Location of Glucagon-Like Peptide (GLP)-1 Release
- ClinicalTrials.gov ID
- NCT02036710
- Acronym / sponsor ID
- 1104M97972
- Conditions
- Obesity
- Keywords
- GLP-1, PYY, Leptin, Duodenal Switch
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Aug 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 15 Jan 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.
Background: Physicians do not have a unified, scientifically tested theory of causation for obesity and its comorbidities, nor do they have explanations for the mechanics of the metabolic/bariatric surgery procedures. Integral to proffered hypotheses are the actions of the hormones glucagon-like peptide (GLP-1), peptide YY (PYY), and leptin.
Study objective: To obtain blood levels of GLP-1, PYY, and leptin after stimulation of the terminal ileum and cecum by a static infusion of a food hydrolysate in morbidly obese patients undergoing a duodenal switch procedure.
Methods: Plasma levels of GLP-1, PYY, and leptin were obtained at 0, 30, 60, 90, and 120 minutes after instillation of 240 ml of a food hydrolysate into the ileum or cecum.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cecum | – | –Food hydrolysate instilled into terminal cecum of patient undergoing open duodenal switch procedure. Blood samples were then obtained at baseline and at 0, 30, 60, 90, and 120 minutes for analysis of circulating GLP-1, PYY, and leptin. |
| Ileum | – | –Food hydrolysate instilled into terminal ileum of patient undergoing open duodenal switch procedure. Blood samples were then obtained at baseline and at 0, 30, 60, 90, and 120 minutes for analysis of circulating GLP-1, PYY, and leptin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study population consisted of morbidly obese individuals who had decided to undergo open duodenal switch surgery
Key inclusion criteria (1 listed)
- Any patient who was qualified and approved for bariatric surgery and elected to undergo open duodenal switch procedure.
Key exclusion criteria (0 listed)
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
GLP-1
Time frame: 2 hours
GLP- levels were measured at intervals over two hours after static bowel food hydrolysate was infused, in patients undergoing scheduled open duodenal switch procedure.
peptide YY (PYY)
Time frame: 2 hours
PYY levels were measured at intervals over two hours after static bowel food hydrolysate was infused, in patients undergoing scheduled open duodenal switch procedure.
Leptin
Time frame: 2 hours
Leptin levels were measured at intervals over two hours after static bowel food hydrolysate was infused, in patients undergoing scheduled open duodenal switch procedure.
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 1 Nov 2019.
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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.
Henry Buchwald, MD, PhD principal investigator
University of Minnesota
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 Minnesota 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 0 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 1 Nov 2019. 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?
GLP-1 (time frame: 2 hours). The study lists 3 primary outcomes in all. 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 1 Nov 2019; AzTrials last refreshed its copy on 1 Nov 2026.