Morbid ObesityNCT01007955
Assessment of Insulin Resistance, NAFLD, Predictors of CV Morbidity, and Subcutaneous Adipose and Visceral Adipose Gene Expression in Patients Undergoing Gastric Bypass Surgery
An observational study of Morbid Obesity and Insulin Resistance, run by University of Massachusetts, Worcester at 1 site in United States.
Trial summary
The purpose of this research is to further study the effect weight loss after gastric bypass surgery has on the heart and blood pressure and on how the body uses or metabolizes the sugars, fats and proteins we eat. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Morbid Obesity, Insulin Resistance, Non-Alcoholic Fatty Liver Disease
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2006to May 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: Severely obese patients undergoing gastric bypass surgery
Who may be able to join
- Morbid Obesity
- Scheduled to undergo gastric bypass surgery
Who cannot join
- Pregnancy (would not be candidate for surgery)
- Nursing (would not be candidate for surgery)
Trial locations and contacts
1 site in 1 country.
United States1 site
UMass Memorial Medical Center
Worcester, Massachusetts, 01655
About this study
Official title: Assessment of Insulin Resistance, Non-Alcoholic Fatty Liver Disease, Predictors of Cardiovascular Morbidity, and Subcutaneous Adipose and Visceral Adipose Gene Expression in Patients Undergoing Gastric Bypass: Development of a New Paradigm in Defining "Morbid Obesity" and in the Application of Bariatric Surgery
The purpose of this research is to further study the effect weight loss after gastric bypass surgery has on the heart and blood pressure and on how the body uses or metabolizes the sugars, fats and proteins we eat. Additionally, the researchers want to study fat tissue for gene patterns which may be responsible for where we carry fat on our bodies, as well as look carefully at a possible link between adipose tissue and insulin resistance. The researchers also want to evaluate the liver for the presence of fatty liver, which is common in people with obesity and is associated with insulin resistance, as well as study the liver for gene patterns which may be associated with non-alcoholic liver disease.
Evaluating cardiovascular function and endocrine function before and after gastric bypass surgery, as well as studying adipose and liver tissue may help us understand the link between obesity, insulin resistance, fatty liver disease, high blood pressure and health problems such as diabetes and heart disease. Consequently, this may help in the future by identifying those who will benefit most from gastric bypass surgery.
Read the detailed description
Obesity is associated with insulin resistance and diabetes. Since both of these conditions have been implicated in cardiovascular complications, this association may explain obesity related illnesses and deaths. Gastric bypass is considered the "gold standard" surgical weightloss procedure and has been demonstrated to cure diabetes and insulin resistance. Some severely obese patients, however, have normal insulin-glucose metabolism. The differences in metabolic healthy in severely obese individuals has not been fully recognized or understood. This research will study insulin-glucose metabolism in a population of severely obese individuals undergoing gastric bypass. This investigation is based on the following hypotheses:
- Severely obese individuals can be categorized by degree to which insulin-glucose homeostasis is impaired.
- The degree of insulin resistance correlates with risk for cardiovascular disease. Weight loss in obese individuals with insulin resistance, will correlate with improvement in parameters associated with cardiovascular disease. Obese individuals with better insulin sensitivity will not have a high risk for cardiovascular disease and therefore will not experience this risk reduction in cardiovascular disease.
- Insulin resistance is a consequence of pathological storage of excess energy intake; therefore, individuals who are insulin resistant and obese will differ from individuals who are obese, but not insulin resistant with regards to gene expression in subcutaneous adipose tissue and visceral adipose tissue.
Subjects will be studied for evidence of end organ dysfunction and predictors of morbidity and mortality preoperatively and postoperatively. Additionally, gene expression in the subcutaneous and visceral adipose depots of subjects will be studied
- Medical subject headings
- Obesity, Morbid, Insulin Resistance, Non-alcoholic Fatty Liver Disease
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 |
|---|---|---|
| Severely Obese | Severely obese individuals scheduled to undergo gastric bypass surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of insulin resistance and/or diabetes
Measured: Two weeks postoperatively, Six months postoperatively, One year postoperatively
Secondary outcomes (1)
Improvement of cardiovascular risk factors
Measured: Two weeks postoperatively, Six months postoperatively, One year postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2009 (estimated)
- Study startNov 2006
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Perugini, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01007955
- Sponsor's protocol ID
- H-12082
- Status last verified
- Aug 2012
- First submitted
- 3 Nov 2009
- Last updated
- 24 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Insulin Resistance, Non-Alcoholic Fatty Liver Disease, Predictors of Cardiovascular Morbidity, and Subcutaneous Adipose and Visceral Adipose Gene Expression in Patients Undergoing Gastric Bypass: Development of a New Paradigm in Defining "Morbid Obesity" and in the Application of Bariatric Surgery
- ClinicalTrials.gov ID
- NCT01007955
- Acronym / sponsor ID
- H-12082
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Study start
- Nov 2006
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 5 Nov 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.
The purpose of this research is to further study the effect weight loss after gastric bypass surgery has on the heart and blood pressure and on how the body uses or metabolizes the sugars, fats and proteins we eat. Additionally, the researchers want to study fat tissue for gene patterns which may be responsible for where we carry fat on our bodies, as well as look carefully at a possible link between adipose tissue and insulin resistance. The researchers also want to evaluate the liver for the presence of fatty liver, which is common in people with obesity and is associated with insulin resistance, as well as study the liver for gene patterns which may be associated with non-alcoholic liver disease.
Evaluating cardiovascular function and endocrine function before and after gastric bypass surgery, as well as studying adipose and liver tissue may help us understand the link between obesity, insulin resistance, fatty liver disease, high blood pressure and health problems such as diabetes and heart disease. Consequently, this may help in the future by identifying those who will benefit most from gastric bypass surgery.
Detailed description
Obesity is associated with insulin resistance and diabetes. Since both of these conditions have been implicated in cardiovascular complications, this association may explain obesity related illnesses and deaths. Gastric bypass is considered the "gold standard" surgical weightloss procedure and has been demonstrated to cure diabetes and insulin resistance. Some severely obese patients, however, have normal insulin-glucose metabolism. The differences in metabolic healthy in severely obese individuals has not been fully recognized or understood. This research will study insulin-glucose metabolism in a population of severely obese individuals undergoing gastric bypass. This investigation is based on the following hypotheses:
- Severely obese individuals can be categorized by degree to which insulin-glucose homeostasis is impaired.
- The degree of insulin resistance correlates with risk for cardiovascular disease. Weight loss in obese individuals with insulin resistance, will correlate with improvement in parameters associated with cardiovascular disease. Obese individuals with better insulin sensitivity will not have a high risk for cardiovascular disease and therefore will not experience this risk reduction in cardiovascular disease.
- Insulin resistance is a consequence of pathological storage of excess energy intake; therefore, individuals who are insulin resistant and obese will differ from individuals who are obese, but not insulin resistant with regards to gene expression in subcutaneous adipose tissue and visceral adipose tissue.
Subjects will be studied for evidence of end organ dysfunction and predictors of morbidity and mortality preoperatively and postoperatively. Additionally, gene expression in the subcutaneous and visceral adipose depots of subjects will be studied
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Severely Obese | – | –Severely obese individuals scheduled to undergo gastric bypass surgery |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Severely obese patients undergoing gastric bypass surgery
Key inclusion criteria (2 listed)
- Morbid Obesity
- Scheduled to undergo gastric bypass surgery
Key exclusion criteria (2 listed)
- Pregnancy (would not be candidate for surgery)
- Nursing (would not be candidate for surgery)
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
Improvement of insulin resistance and/or diabetes
Time frame: Two weeks postoperatively, Six months postoperatively, One year postoperatively
1 secondary outcome
Improvement of cardiovascular risk factors
Time frame: Two weeks postoperatively, Six months postoperatively, One year postoperatively
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 24 Aug 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Morbid Obesity and Insulin Resistance, run by University of Massachusetts, Worcester 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 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 24 Aug 2012. 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?
Improvement of insulin resistance and/or diabetes (time frame: Two weeks postoperatively, Six months postoperatively, One year postoperatively). 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 24 Aug 2012.