ObesityPhase 1NCT00884494
Ghrelin and Insulin Resistance
A Phase 1 study testing Ghrelin infusion to assess effects on insulin sensitivity in people with Obesity and Insulin Resistance, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
Ghrelin, a hormone produced in the stomach that stimulates hunger and food intake, declines immediately after weight loss surgery. Some studies suggest that ghrelin may worsen an individual's ability to respond to insulin. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Insulin Resistance, Normal Weight,Healthy Controls
- What is being tested?
- Ghrelin infusion to assess effects on insulin sensitivity
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to May 2014
- Phase
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-65
- BMI > 35 kg/m2
- Scheduled for bariatric surgery at Vanderbilt University Medical Center
- Age 18-65
- BMI < 30kg/m2
Who cannot join
- Prior bariatric surgery
- Serum creatinine > 1.5 mg/dl
- Hepatic enzyme elevations > 2x upper limits of normal
- Current use of warfarin or clopidogrel
- Intercurrent infections
- Females with positive pregnancy test
- Abnormal ECG
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: Role of Ghrelin in the Improvement of Insulin Resistance After Roux-en-Y Gastric Bypass Surgery
Ghrelin, a hormone produced in the stomach that stimulates hunger and food intake, declines immediately after weight loss surgery. Some studies suggest that ghrelin may worsen an individual's ability to respond to insulin. The purpose of this study is to determine if the decline in ghrelin levels after weight loss surgery contributes to the improvement of insulin sensitivity.
- Conditions
- Obesity, Insulin Resistance, Normal Weight,Healthy Controls
- Being tested
- Ghrelin infusion to assess effects on insulin sensitivity
- Keywords
- Obesity, Insulin resistance, Ghrelin
- Medical subject headings
- Obesity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ghrelin infusion to assess effects on insulin sensitivityDrug
| Study group | Role | What they receive |
|---|---|---|
| Roux-en-Y gastric bypass | Experimental | Not described Receives: Drug: Ghrelin infusion to assess effects on insulin sensitivity |
| Lean | Experimental | Not described Receives: Drug: Ghrelin infusion to assess effects on insulin sensitivity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the effect of ghrelin on insulin resistance in obese subject, as well as subjects in the immediate post-RYGB period.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2009 (estimated)
- Study startAug 2011
- Primary completionMay 2014
- Study completionMay 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.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- 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
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robyn Tamboli, Vanderbilt University Medical Center
- Investigators
- Robyn Tamboli, PhD, Principal investigator, Vanderbilt University Medical CenterNaji Abumrad, MD, Study director, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00884494
- Sponsor's protocol ID
- IRB#090362
- Other IDs
- NIH: RO1-DK070860-01S1
- Status last verified
- Jan 2017
- First submitted
- 16 Apr 2009
- Last updated
- 20 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Garcia AE, Kasim N, Tamboli RA, Gonzalez RS, Antoun J, Eckert EA, Marks-Shulman PA, Dunn J, Wattacheril J, Wallen T, Abumrad NN, Flynn CR. Lipoprotein Profiles in Class III Obese Caucasian and African American Women with Nonalcoholic Fatty Liver Disease. PLoS One. 2015 Nov 23;10(11):e0142676. doi: 10.1371/journal.pone.0142676. eCollection 2015.
PubMed 26599819
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Ghrelin in the Improvement of Insulin Resistance After Roux-en-Y Gastric Bypass Surgery
- ClinicalTrials.gov ID
- NCT00884494
- Acronym / sponsor ID
- IRB#090362
- Conditions
- Obesity, Insulin Resistance, Normal Weight,Healthy Controls
- Keywords
- Obesity, Insulin resistance, Ghrelin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 20 Apr 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.
Ghrelin, a hormone produced in the stomach that stimulates hunger and food intake, declines immediately after weight loss surgery. Some studies suggest that ghrelin may worsen an individual's ability to respond to insulin. The purpose of this study is to determine if the decline in ghrelin levels after weight loss surgery contributes to the improvement of insulin sensitivity.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Roux-en-Y gastric bypass | Experimental | Drug: Ghrelin infusion to assess effects on insulin sensitivity |
| Lean | Experimental | Drug: Ghrelin infusion to assess effects on insulin sensitivity |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-65
- BMI > 35 kg/m2
- Scheduled for bariatric surgery at Vanderbilt University Medical Center
- Age 18-65
- BMI < 30kg/m2
Key exclusion criteria (7 listed)
- Prior bariatric surgery
- Serum creatinine > 1.5 mg/dl
- Hepatic enzyme elevations > 2x upper limits of normal
- Current use of warfarin or clopidogrel
- Intercurrent infections
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 |
|---|---|---|
| Ghrelin infusion to assess effects on insulin sensitivity | Drug | Lean, Roux-en-Y gastric bypass |
Primary outcome
Evaluate the effect of ghrelin on insulin resistance in obese subject, as well as subjects in the immediate post-RYGB period.
Time frame: 1 year
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 Jan 2017.
- Derived from this study: PubMed 26599819Garcia AE, Kasim N, Tamboli RA, Gonzalez RS, Antoun J, Eckert EA, Marks-Shulman PA, Dunn J, Wattacheril J, Wallen T, Abumrad NN, Flynn CR. Lipoprotein Profiles in Class III Obese Caucasian and African American Women with Nonalcoholic Fatty Liver Disease. PLoS One. 2015 Nov 23;10(11):e0142676. doi: 10.1371/journal.pone.0142676. eCollection 2015.
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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.
Robyn Tamboli, PhD principal investigator
Vanderbilt University Medical Center
Naji Abumrad, MD study director
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ghrelin infusion to assess effects on insulin sensitivity in people with Obesity and Insulin Resistance, run by Vanderbilt University Medical Center 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 5 inclusion and 7 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 Jan 2017. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Evaluate the effect of ghrelin on insulin resistance in obese subject, as well as subjects in the immediate post-RYGB period. (time frame: 1 year). 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 NCT00884494, 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 20 Jan 2017.