ObesityRnonRNCT00908973
Gut Hormone Response, Appetite and Intestinal Transit Time in Good and Poor Weight Responders After Gastric Bypass
An observational study of Obesity, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
The aim of the study is to describe differences in meal-stimulated gut hormone response, appetite and intestinal transit time between good and poor responders 1-2 years after Gastric Bypass surgery for obesity. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- How many people
- 46 participants
- Where
- 1 siteDenmark
- Study dates
- May 2009to Dec 2011
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Case subjects are recruited from the outpatient clinic of endocrinology at Hvidovre University Hospital. Control subjects are recruited through announcement in local newspapers.
Who may be able to join
- Age 20-60 years
- Completed laparoscopic gastric bypass surgery without complications (cases)
- No previous gastric bypass surgery (controls)
Who cannot join
- Diabetes
- Disease or treatment interfering with appetite or gastrointestinal motility
- Pregnancy or breastfeeding
- Excess weight loss 1 year after gastric bypass > 50% and =< 60% (cases)
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Endocrinology at Hvidovre University Hospital
Hvidovre, Copenhagen, DK-2650
About this study
Official title: Gut Hormone Response, Appetite and Intestinal Transit Time in Good and Poor Weight Responders 1-2 Years After Gastric Bypass
The aim of the study is to describe differences in meal-stimulated gut hormone response, appetite and intestinal transit time between good and poor responders 1-2 years after Gastric Bypass surgery for obesity.
- Conditions
- Obesity
- Keywords
- Obesity, Gastric bypass, Gut hormone, Intestinal transit time
- 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 |
|---|---|---|
| Good responders | Excess weight loss of > 60% 1 year after gastric bypass surgery | |
| Poor responders | Excess weight loss of =< 50% 1 year after gastric bypass surgery | |
| Lean controls | Non-gastric bypass operated lean individuals, matched for age and sex |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2009 (estimated)
- Study startMay 2009
- Primary completionJun 2011
- Study completionDec 2011
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
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen, Novo Nordisk A/S
- Responsible party
- Principal investigator, Carsten Dirksen, Hvidovre University Hospital
- Investigators
- Carsten Dirksen, MD, Principal investigator, Dept. of Endocrinology, Hvidovre University Hospital, Hvidovre, Copenhagen, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00908973
- Sponsor's protocol ID
- RnonR
- Acronym
- RnonR
- Status last verified
- Mar 2012
- First submitted
- 26 May 2009
- Last updated
- 20 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gut Hormone Response, Appetite and Intestinal Transit Time in Good and Poor Weight Responders 1-2 Years After Gastric Bypass
- ClinicalTrials.gov ID
- NCT00908973
- Acronym / sponsor ID
- RnonR / RnonR
- Conditions
- Obesity
- Keywords
- Obesity, Gastric bypass, Gut hormone, Intestinal transit time
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Collaborators
- University of Copenhagen, Novo Nordisk A/S
- Study start
- May 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 27 May 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.
The aim of the study is to describe differences in meal-stimulated gut hormone response, appetite and intestinal transit time between good and poor responders 1-2 years after Gastric Bypass surgery for obesity.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Good responders | – | –Excess weight loss of > 60% 1 year after gastric bypass surgery |
| Poor responders | – | –Excess weight loss of =< 50% 1 year after gastric bypass surgery |
| Lean controls | – | –Non-gastric bypass operated lean individuals, matched for age and sex |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Case subjects are recruited from the outpatient clinic of endocrinology at Hvidovre University Hospital. Control subjects are recruited through announcement in local newspapers.
Key inclusion criteria (3 listed)
- Age 20-60 years
- Completed laparoscopic gastric bypass surgery without complications (cases)
- No previous gastric bypass surgery (controls)
Key exclusion criteria (4 listed)
- Diabetes
- Disease or treatment interfering with appetite or gastrointestinal motility
- Pregnancy or breastfeeding
- Excess weight loss 1 year after gastric bypass > 50% and =< 60% (cases)
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 20 Mar 2012.
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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.
Carsten Dirksen, MD principal investigator
Dept. of Endocrinology, Hvidovre University Hospital, Hvidovre, Copenhagen, Denmark
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 Hvidovre University Hospital at 1 site in Denmark.
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 3 inclusion and 4 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 20 Mar 2012. 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 Denmark. 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 20 Mar 2012.