ObesityNCT02161666
Effect of Gastric Bypass Surgery on Pancreatic Islet and Incretin Function - Follow-up Study
An observational study of Obesity, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
To examine pancreatic islet function and incretin function during intravenous and oral stimulation >2 years after gastric bypass surgery in patients with normal glucose tolerance. We hypothesize that islet cell and incretin function is enhanced in response to oral, but not intravenous, stimulation - i.e. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- How many people
- 7 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2014to Dec 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients are recruited from the population undergoing gastric bypass surgery at Hvidovre Hospital (Denmark)
Who may be able to join
- Participation in previous study (NCT01559779)
Who cannot join
- Pregnancy/lactation
- Major chronic disease develop since previous examination with possible impact on outcomes
Trial locations and contacts
1 site in 1 country.
About this study
To examine pancreatic islet function and incretin function during intravenous and oral stimulation >2 years after gastric bypass surgery in patients with normal glucose tolerance. We hypothesize that islet cell and incretin function is enhanced in response to oral, but not intravenous, stimulation - i.e. incretin released from the gut in response to oral stimulation play a key role for the enhanced islet function after gastric bypass surgery.
- Conditions
- Obesity
- Keywords
- Obesity, Gastric Bypass, Bariatric Surgery, Incretin Function, Islet Function
- 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 |
|---|---|---|
| Patients | Morbidly obese patients with normal glucose tolerance undergoing gastric bypass surgery | |
| Controls | Age, sex and BMI-matched healthy controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in islet cell function from baseline (preoperatively)
Change in insulin and glucagon secretion during oral and intravenous stimulation after gastric bypass
Measured: >24 months
Secondary outcomes (2)
Change in glucose tolerance during oral glucose tolerance test
Fasting, peak and nadir glucose during oral glucose tolerance test
Measured: >24 months
Arterio-venous glucose difference during oral glucose tolerance test after gastric bypass
Differences in arterial and venous plasma glucose during oral glucose stimulation
Measured: >24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2014 (estimated)
- Study startFeb 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carsten Dirksen, Hvidovre University Hospital
- Investigators
- Carsten Dirksen, MD, PhD, Principal investigator, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02161666
- Sponsor's protocol ID
- AB-CD-10-2Y
- Status last verified
- Apr 2015
- First submitted
- 10 Jun 2014
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Dirksen C, Eiken A, Bojsen-Moller KN, Svane MS, Martinussen C, Jorgensen NB, Holst JJ, Madsbad S. No Islet Cell Hyperfunction, but Altered Gut-Islet Regulation and Postprandial Hypoglycemia in Glucose-Tolerant Patients 3 Years After Gastric Bypass Surgery. Obes Surg. 2016 Sep;26(9):2263-2267. doi: 10.1007/s11695-016-2197-x.
PubMed 27138601
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Gastric Bypass Surgery on Pancreatic Islet and Incretin Function - Follow-up Study
- ClinicalTrials.gov ID
- NCT02161666
- Acronym / sponsor ID
- AB-CD-10-2Y
- Conditions
- Obesity
- Keywords
- Obesity, Gastric Bypass, Bariatric Surgery, Incretin Function, Islet Function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 12 Jun 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.
To examine pancreatic islet function and incretin function during intravenous and oral stimulation >2 years after gastric bypass surgery in patients with normal glucose tolerance. We hypothesize that islet cell and incretin function is enhanced in response to oral, but not intravenous, stimulation - i.e. incretin released from the gut in response to oral stimulation play a key role for the enhanced islet function after gastric bypass surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | –Morbidly obese patients with normal glucose tolerance undergoing gastric bypass surgery |
| Controls | – | –Age, sex and BMI-matched healthy controls |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients are recruited from the population undergoing gastric bypass surgery at Hvidovre Hospital (Denmark)
Key inclusion criteria (1 listed)
- Participation in previous study (NCT01559779)
Key exclusion criteria (2 listed)
- Pregnancy/lactation
- Major chronic disease develop since previous examination with possible impact on outcomes
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
Change in islet cell function from baseline (preoperatively)
Time frame: >24 months
Change in insulin and glucagon secretion during oral and intravenous stimulation after gastric bypass
2 secondary outcomes
Change in glucose tolerance during oral glucose tolerance test
Time frame: >24 months
Arterio-venous glucose difference during oral glucose tolerance test after gastric bypass
Time frame: >24 months
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 7 Apr 2015.
- Derived from this study: PubMed 27138601Dirksen C, Eiken A, Bojsen-Moller KN, Svane MS, Martinussen C, Jorgensen NB, Holst JJ, Madsbad S. No Islet Cell Hyperfunction, but Altered Gut-Islet Regulation and Postprandial Hypoglycemia in Glucose-Tolerant Patients 3 Years After Gastric Bypass Surgery. Obes Surg. 2016 Sep;26(9):2263-2267. doi: 10.1007/s11695-016-2197-x.
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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, PhD principal investigator
Hvidovre University 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, 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 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 7 Apr 2015. 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.
What does the primary outcome measure?
Change in islet cell function from baseline (preoperatively) (time frame: >24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02161666, which also lists 1 linked publication.
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 7 Apr 2015.