ObesityNCT00765596
Ghrelin Changes After Roux-en-Y Gastric Bypass
An observational study of Obesity and Insulin Resistance, run by Vanderbilt University at 1 site in United States.
Trial summary
The purpose of this study is to determine whether gastric division (via Roux-en-Y gastric bypass) with resultant fundic isolation will alter the pattern(s) of Ghrelin secretion in the early post-operative period following feeding in morbidly obese subjects. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obesity, Insulin Resistance
- What is being tested?
- Liquid diet for 3 days
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Dec 2006
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Subjects were morbidly obese, scheduled for RYGB with gastric tube placement. Controls were matched to subjects by BMI, age, gender.
Who may be able to join
- Serum creatinine and liver function tests < upper limits of normal
- Stable body weights for the past three months
- Women will have a negative pregnancy test
- patients who are already scheduled for RYGB with gastrostomy tube placement
Who cannot join
- Significant hepatic enzyme elevations (more than 100% of upper limits of normal)
- Serum creatinine > 1.5 mg/dl
- history of ketoacidosis or current metabolic acidosis
- current use of oral anticoagulants
- Positive pregnancy test (beta-human chorionic gonadotrophin) for females
- intercurrent infections
- patients with prior gastric operations
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: Ghrelin Changes After Roux-en-Y Gastric Bypass: Does Gastric Pouch vs. Gastric Remnant Feeding Affect Secretion?
The purpose of this study is to determine whether gastric division (via Roux-en-Y gastric bypass) with resultant fundic isolation will alter the pattern(s) of Ghrelin secretion in the early post-operative period following feeding in morbidly obese subjects.
- Conditions
- Obesity, Insulin Resistance
- Being tested
- Liquid diet for 3 days
- Keywords
- Obesity, Insulin resistance, Gastric tube, 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.
Liquid diet for 3 daysOther
The control group were given a 3 -day liquid diet similar to the RYGB post-op diet
| Study group | Role | What they receive |
|---|---|---|
| 1 RYGB | Subjects undergoing RYGB with gastric tube placement | |
| 2 Matched controls | Subjects matched by BMI, age, gender to RYGB group Receives: Other: Liquid diet for 3 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ghrelin
Measured: pre-op, peri-op, immediately post-op, 2 days, 3 wks, 6wks, 6mos, 1 year post op
Secondary outcomes (2)
HOMA
Measured: pre-op, peri-op, immediately post-op, 2 days, 3 wks, 6wks, 6mos, 1 year post op
metabolic hormones
Measured: pre-op, peri-op, immediately post-op, 2 days, 3 wks, 6wks, 6mos, 1 year post op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2008 (estimated)
- Study startJan 2005
- Primary completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naji Abumrad, Vanderbilt University
- Investigators
- Naji N Abumrad, MD, Principal investigator, Department of Surgery, Vanderbilt University Medical CenterErik N Hansen, MD, Principal investigator, Departement of Surgery, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00765596
- Sponsor's protocol ID
- IRB#041129
- Status last verified
- Nov 2011
- First submitted
- 2 Oct 2008
- Last updated
- 17 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Hansen EN, Tamboli RA, Isbell JM, Saliba J, Dunn JP, Marks-Shulman PA, Abumrad NN. Role of the foregut in the early improvement in glucose tolerance and insulin sensitivity following Roux-en-Y gastric bypass surgery. Am J Physiol Gastrointest Liver Physiol. 2011 May;300(5):G795-802. doi: 10.1152/ajpgi.00019.2011. Epub 2011 Mar 3.
PubMed 21372167Isbell JM, Tamboli RA, Hansen EN, Saliba J, Dunn JP, Phillips SE, Marks-Shulman PA, Abumrad NN. The importance of caloric restriction in the early improvements in insulin sensitivity after Roux-en-Y gastric bypass surgery. Diabetes Care. 2010 Jul;33(7):1438-42. doi: 10.2337/dc09-2107. Epub 2010 Apr 5.
PubMed 20368410
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ghrelin Changes After Roux-en-Y Gastric Bypass: Does Gastric Pouch vs. Gastric Remnant Feeding Affect Secretion?
- ClinicalTrials.gov ID
- NCT00765596
- Acronym / sponsor ID
- IRB#041129
- Conditions
- Obesity, Insulin Resistance
- Keywords
- Obesity, Insulin resistance, Gastric tube, Ghrelin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Dec 2006 (actual)
- First posted
- 3 Oct 2008 (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 purpose of this study is to determine whether gastric division (via Roux-en-Y gastric bypass) with resultant fundic isolation will alter the pattern(s) of Ghrelin secretion in the early post-operative period following feeding in morbidly obese subjects.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 RYGB | – | –Subjects undergoing RYGB with gastric tube placement |
| 2 Matched controls | – | Other: Liquid diet for 3 daysSubjects matched by BMI, age, gender to RYGB group |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Subjects were morbidly obese, scheduled for RYGB with gastric tube placement. Controls were matched to subjects by BMI, age, gender.
Key inclusion criteria (4 listed)
- Serum creatinine and liver function tests < upper limits of normal
- Stable body weights for the past three months
- Women will have a negative pregnancy test
- patients who are already scheduled for RYGB with gastrostomy tube placement
Key exclusion criteria (7 listed)
- Significant hepatic enzyme elevations (more than 100% of upper limits of normal)
- Serum creatinine > 1.5 mg/dl
- history of ketoacidosis or current metabolic acidosis
- current use of oral anticoagulants
- Positive pregnancy test (beta-human chorionic gonadotrophin) for females
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 |
|---|---|---|
| Liquid diet for 3 daysThe control group were given a 3 -day liquid diet similar to the RYGB post-op diet | Other | 2 Matched controls |
Primary outcome
Ghrelin
Time frame: pre-op, peri-op, immediately post-op, 2 days, 3 wks, 6wks, 6mos, 1 year post op
2 secondary outcomes
HOMA
Time frame: pre-op, peri-op, immediately post-op, 2 days, 3 wks, 6wks, 6mos, 1 year post op
metabolic hormones
Time frame: pre-op, peri-op, immediately post-op, 2 days, 3 wks, 6wks, 6mos, 1 year post op
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 17 Nov 2011.
- Derived from this study: PubMed 21372167Hansen EN, Tamboli RA, Isbell JM, Saliba J, Dunn JP, Marks-Shulman PA, Abumrad NN. Role of the foregut in the early improvement in glucose tolerance and insulin sensitivity following Roux-en-Y gastric bypass surgery. Am J Physiol Gastrointest Liver Physiol. 2011 May;300(5):G795-802. doi: 10.1152/ajpgi.00019.2011. Epub 2011 Mar 3.
- Derived from this study: PubMed 20368410Isbell JM, Tamboli RA, Hansen EN, Saliba J, Dunn JP, Phillips SE, Marks-Shulman PA, Abumrad NN. The importance of caloric restriction in the early improvements in insulin sensitivity after Roux-en-Y gastric bypass surgery. Diabetes Care. 2010 Jul;33(7):1438-42. doi: 10.2337/dc09-2107. Epub 2010 Apr 5.
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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.
Naji N Abumrad, MD principal investigator
Department of Surgery, Vanderbilt University Medical Center
Erik N Hansen, MD principal investigator
Departement of Surgery, 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?
An observational study of Obesity and Insulin Resistance, run by Vanderbilt University 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 4 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 17 Nov 2011. 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.
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?
Ghrelin (time frame: pre-op, peri-op, immediately post-op, 2 days, 3 wks, 6wks, 6mos, 1 year post op). 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 NCT00765596, which also lists 2 linked publications.
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 17 Nov 2011.