ObesityAB-CD-10NCT01559779
Effect of Gastric Bypass Surgery on Pancreatic Islets and Incretin Function
An observational study of Obesity, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
The study aims at describing the acute and subacute changes after Roux-en-Y (RYGB) gastric bypass in insulin secretion from the beta cell and glucagon secretion from the alpha cell as well as the stimulatory effect of the incretins on the pancreatic islets. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- How many people
- 11 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2010to Dec 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects are recruited from the population undergoing gastric bypass surgery at Hvidovre Hospital
Who may be able to join
- Normal glucose tolerance
- Age > 18 years
- BMI > 40 or > 35 if combined with hypertension or obstructive sleep apnoea
- Caucasian
- Normal hemoglobinaemia
- Signed informed consent
Who cannot join
- Major psychiatric disorder
- Alcohol or drug abuse
- Major hearth or pulmonary disease
- Previous major abdominal disease (e.g. peritonitis, large hernia)
- Pregnancy/lactation
- Treatment with GLP-1 analogs
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Dpt. of Endocrinology (215) at Hvidovre Hospital
Hvidovre, Copenhagen, 2650
About this study
Official title: The Effect of Gastric Bypass Surgery on the Beta- and Alpha Cells Secretory Function and the Insulinotropic Effect of the Incretin Hormones
The study aims at describing the acute and subacute changes after Roux-en-Y (RYGB) gastric bypass in insulin secretion from the beta cell and glucagon secretion from the alpha cell as well as the stimulatory effect of the incretins on the pancreatic islets. RYGB is a bariatric procedure that changes the gastrointestinal anatomy and has been demonstrated to cause remission of type 2 diabetes shortly after the operation, before any significant weight loss. The altered transit of nutrient through the gastrointestinal tract after the operation is thought to play a key role in this remission and studies have shown significant changes in the secretion of gut hormones, namely the incretin hormone glucagon-like peptide-1 (GLP-1). However it is unknown whether the secretory function of the pancreatic islets as well as the stimulatory effect of the incretin hormones is changes postoperatively.
- Conditions
- Obesity
- Keywords
- Obesity, Roux-en-Y gastric bypass, Incretin hormones, Beta cell 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 |
|---|---|---|
| Normal glucose tolerance | Morbidly obese subjects with normal glucose tolerance undergoing gastric bypass surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in beta cell function
Change in first and second phase insulin response, disposition index, and acute insulin secretion in response to a non-glucose stimulus
Measured: Before and 1 week and 3 months after surgery
Insulinotropic effect of incretin hormones
Change in first and second phase insulin response during GLP-1 and GIP infusion compared to saline
Measured: Before and 1 week and 3 months after surgery
Secondary outcomes (1)
Change in alpha cell function
Change in glucagon secretion in response to glucose and non-glucose stimuli
Measured: Before and 1 week and 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2012 (estimated)
- Study startNov 2010
- Primary completionJul 2012
- Study completionDec 2012
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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Responsible party
- Principal investigator, Carsten Dirksen, Hvidovre University Hospital
- Investigators
- Carsten Dirksen, MD, Principal investigator, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01559779
- Sponsor's protocol ID
- AB-CD-10
- Acronym
- AB-CD-10
- Status last verified
- Jun 2014
- First submitted
- 19 Mar 2012
- Last updated
- 10 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Dirksen C, Bojsen-Moller KN, Jorgensen NB, Jacobsen SH, Kristiansen VB, Naver LS, Hansen DL, Worm D, Holst JJ, Madsbad S. Exaggerated release and preserved insulinotropic action of glucagon-like peptide-1 underlie insulin hypersecretion in glucose-tolerant individuals after Roux-en-Y gastric bypass. Diabetologia. 2013 Dec;56(12):2679-87. doi: 10.1007/s00125-013-3055-1. Epub 2013 Sep 19.
PubMed 24048673
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Gastric Bypass Surgery on the Beta- and Alpha Cells Secretory Function and the Insulinotropic Effect of the Incretin Hormones
- ClinicalTrials.gov ID
- NCT01559779
- Acronym / sponsor ID
- AB-CD-10 / AB-CD-10
- Conditions
- Obesity
- Keywords
- Obesity, Roux-en-Y gastric bypass, Incretin hormones, Beta cell function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- Nov 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 21 Mar 2012 (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 study aims at describing the acute and subacute changes after Roux-en-Y (RYGB) gastric bypass in insulin secretion from the beta cell and glucagon secretion from the alpha cell as well as the stimulatory effect of the incretins on the pancreatic islets. RYGB is a bariatric procedure that changes the gastrointestinal anatomy and has been demonstrated to cause remission of type 2 diabetes shortly after the operation, before any significant weight loss. The altered transit of nutrient through the gastrointestinal tract after the operation is thought to play a key role in this remission and studies have shown significant changes in the secretion of gut hormones, namely the incretin hormone glucagon-like peptide-1 (GLP-1). However it is unknown whether the secretory function of the pancreatic islets as well as the stimulatory effect of the incretin hormones is changes postoperatively.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Normal glucose tolerance | – | –Morbidly obese subjects with normal glucose tolerance undergoing gastric bypass surgery |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects are recruited from the population undergoing gastric bypass surgery at Hvidovre Hospital
Key inclusion criteria (6 listed)
- Normal glucose tolerance
- Age > 18 years
- BMI > 40 or > 35 if combined with hypertension or obstructive sleep apnoea
- Caucasian
- Normal hemoglobinaemia
Key exclusion criteria (6 listed)
- Major psychiatric disorder
- Alcohol or drug abuse
- Major hearth or pulmonary disease
- Previous major abdominal disease (e.g. peritonitis, large hernia)
- Pregnancy/lactation
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 beta cell function
Time frame: Before and 1 week and 3 months after surgery
Change in first and second phase insulin response, disposition index, and acute insulin secretion in response to a non-glucose stimulus
Insulinotropic effect of incretin hormones
Time frame: Before and 1 week and 3 months after surgery
Change in first and second phase insulin response during GLP-1 and GIP infusion compared to saline
1 secondary outcome
Change in alpha cell function
Time frame: Before and 1 week and 3 months after surgery
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 10 Jun 2014.
- Derived from this study: PubMed 24048673Dirksen C, Bojsen-Moller KN, Jorgensen NB, Jacobsen SH, Kristiansen VB, Naver LS, Hansen DL, Worm D, Holst JJ, Madsbad S. Exaggerated release and preserved insulinotropic action of glucagon-like peptide-1 underlie insulin hypersecretion in glucose-tolerant individuals after Roux-en-Y gastric bypass. Diabetologia. 2013 Dec;56(12):2679-87. doi: 10.1007/s00125-013-3055-1. Epub 2013 Sep 19.
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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
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 6 inclusion and 6 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 10 Jun 2014. 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 beta cell function (time frame: Before and 1 week and 3 months after surgery). The study lists 2 primary outcomes in all. 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 NCT01559779, 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 10 Jun 2014.