Type 2 Diabetes MellitusEarly Phase 1NCT01843855
The Contribution of Incretin Hormones to the Amelioration of Glucose Metabolism After Roux-en-Y Gastric Bypass
A Early Phase 1 study testing Exendin 9,39 in people with Type 2 Diabetes Mellitus, run by Adrian Vella at 1 site in United States.
Trial summary
The study is being undertaken to understand how a gastric bypass can affect a subject's diabetes even prior to their losing significant amounts of weight. The hypothesis of this study is that increased glucagon-like peptide-1 (GLP-1) secretion explains the amelioration in insulin secretion after Roux-en-Y Gastric… Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Exendin 9,39
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Sep 2013
- Phase
- Early Phase 1
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with type 2 diabetes mellitus or impaired fasting glucose concentration of > 110 mg/dL
- Subjects registered to receive a Roux-en-Y Gastric Bypass (RYGB).
Who cannot join
- Subjects taking thiazolidinediones
- Subjects with active systemic illness
- Subjects with active microvascular or macrovascular complications of their diabetes
- For female subject: positive pregnancy test at the time of enrollment in study
Trial locations and contacts
1 site in 1 country.
About this study
The study is being undertaken to understand how a gastric bypass can affect a subject's diabetes even prior to their losing significant amounts of weight. The hypothesis of this study is that increased glucagon-like peptide-1 (GLP-1) secretion explains the amelioration in insulin secretion after Roux-en-Y Gastric Bypass (RYGB) surgery.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Exendin 9,39, Placebo
- Keywords
- Gastric Bypass, bariatric surgery, glucose metabolism
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exendin 9,39Drug
Exendin 9,39 is a competitive antagonist of endogenous GLP-1.
PlaceboDrug
A saline infusion will be given to match the study drug infusion.
| Study group | Role | What they receive |
|---|---|---|
| Exendin 9,39 | Experimental | Subjects randomized to this arm will receive an infusion of exendin 9,39 of 300mmol/kg/min for 360 minutes. Receives: Drug: Exendin 9,39 |
| Placebo | Placebo comparator | Subjects randomized to this arm will receive a saline infusion for 360 minutes. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Total Disposition Index from Study 1 (pre-RYGB) to Study 2 (post-RYGB)
The total disposition index equals the product of insulin secretion and insulin sensitivity.
Measured: baseline, 4 weeks post-operative intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2013 (estimated)
- Study startJun 2011
- Primary completionJul 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adrian Vella
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Center for Research Resources (NCRR)
- Responsible party
- Sponsor-investigator, Adrian Vella, Mayo Clinic
- Investigators
- Adrian Vella, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01843855
- Sponsor's protocol ID
- 11-000161
- Other IDs
- R01DK082396, UL1RR024150
- Status last verified
- Dec 2013
- First submitted
- 26 Apr 2013
- Last updated
- 4 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Contribution of Incretin Hormones to the Amelioration of Glucose Metabolism After Roux-en-Y Gastric Bypass
- ClinicalTrials.gov ID
- NCT01843855
- Acronym / sponsor ID
- 11-000161
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Gastric Bypass, bariatric surgery, glucose metabolism
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Adrian VellaUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Center for Research Resources (NCRR)
- Study start
- Jun 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 1 May 2013 (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 is being undertaken to understand how a gastric bypass can affect a subject's diabetes even prior to their losing significant amounts of weight. The hypothesis of this study is that increased glucagon-like peptide-1 (GLP-1) secretion explains the amelioration in insulin secretion after Roux-en-Y Gastric Bypass (RYGB) surgery.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exendin 9,39 | Experimental | Drug: Exendin 9,39Subjects randomized to this arm will receive an infusion of exendin 9,39 of 300mmol/kg/min for 360 minutes. |
| Placebo | Placebo comparator | Drug: PlaceboSubjects randomized to this arm will receive a saline infusion for 360 minutes. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects with type 2 diabetes mellitus or impaired fasting glucose concentration of > 110 mg/dL
- Subjects registered to receive a Roux-en-Y Gastric Bypass (RYGB).
Key exclusion criteria (4 listed)
- Subjects taking thiazolidinediones
- Subjects with active systemic illness
- Subjects with active microvascular or macrovascular complications of their diabetes
- For female subject: positive pregnancy test at the time of enrollment in study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exendin 9,39Exendin 9,39 is a competitive antagonist of endogenous GLP-1. | Drug | Exendin 9,39 |
| PlaceboA saline infusion will be given to match the study drug infusion. | Drug | Placebo |
Primary outcome
Change in Total Disposition Index from Study 1 (pre-RYGB) to Study 2 (post-RYGB)
Time frame: baseline, 4 weeks post-operative intervention
The total disposition index equals the product of insulin secretion and insulin sensitivity.
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 4 Dec 2013.
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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.
Adrian Vella, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Exendin 9,39 in people with Type 2 Diabetes Mellitus, run by Adrian Vella 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 2 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 4 Dec 2013. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Total Disposition Index from Study 1 (pre-RYGB) to Study 2 (post-RYGB) (time frame: baseline, 4 weeks post-operative intervention). 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 4 Dec 2013.