ObesityNCT00280527
Protocol for the Assessment of Variability in Histology and Gene Expression in Bariatric Surgery Patients.
An observational study of Obesity, run by Northwestern University at 1 site in United States.
Trial summary
It is known that a vast majority of patients seeking a bariatric surgery weight reduction procedure have non-alcoholic fatty liver disease (NAFLD), while a smaller subset of patients within this group have a more serious liver problem known as nonalcoholic steatohepatitis (NASH). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Sep 2008
- 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: This will be a prospective trial of obese patients with presumed NAFLD undergoing bariatric surgery. Patients will be enrolled at Northwestern Memorial Hospital through the bariatric surgery clinic.
Who may be able to join
- Subjects must be willing to give written informed consent
- Subjects must fulfill the criteria for bariatric surgery that have been recommended by a National Institutes of Health (NIH) consensus conference.
- These criteria include:
- The patient should be greater than 100 pounds above desirable body weight or a Body Mass Index (BMI) >40 kg/m2.
- Presence of significant obesity-related illnesses with a BMI of 35-40 kg/m2.
- Failure of sustained weight loss on supervised dietary and/or medical regimens.
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- Patient shows understanding of the risks and benefits of surgery and understands lifestyle changes subsequent to the operation.
- Acceptable operative risk.
- Adult subjects 18-65 years of age of any race or gender
Who cannot join
- Anti - smooth muscle Ab < 1:80.
- Serum Hepatitis B surface antigen (HepBsAg) negative.
- Serum Hepatitis C Antibody (HepC Ab) negative
- Iron/TIBC ratio (transferrin saturation) < 45%
- Alpha-1-antitrypsin level within normal limits
- Ceruloplasmin level within normal limits.
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- Negative pregnancy test (females)
- No active drug abuse or within 6 months
- Etoh consumption < 20g/day (males) or < 10 g/day (females) - Assessed by one physician and confirmed with one family member.
- No known diagnosis of malignancy
- Any other conditions which the investigator feels would make the subject unsuitable for enrollment, or could interfere with the subject completing the protocol.
Trial locations and contacts
1 site in 1 country.
About this study
It is known that a vast majority of patients seeking a bariatric surgery weight reduction procedure have non-alcoholic fatty liver disease (NAFLD), while a smaller subset of patients within this group have a more serious liver problem known as nonalcoholic steatohepatitis (NASH). NASH is a serious liver disease that can lead to cirrhosis, liver failure and ultimately liver transplantation. The purpose of this study is to explore the effects of bariatric surgery on the progression of NASH. The investigators also hope to gain insight into which genes may be responsible for the development of NAFLD and NASH. The knowledge gained from this study will advance the field of fatty liver disease and help design rational treatments to prevent disease progression.
Read the detailed description
Nonalcoholic fatty liver disease (NAFLD) is the most common cause of abnormal liver tests in the United States. NAFLD is often found in association with obesity and diabetes and it is expected to become increasingly prevalent as the incidence of diabetes and obesity continues to increase. NAFLD represents a range of diseases from simple fatty deposition in the liver to more aggressive inflammation and fibrosis, termed nonalcoholic steatohepatitis (NASH). The distinction of NASH as an entity within NAFLD is an important one, as the natural history of this disease is different. Ultimately, NASH may progress to cirrhosis in up to 25% of patients, compared to simple steatosis which is a benign condition.
NAFLD has been estimated at 10-24% in various populations and is significantly higher in obese populations (57.5-74%). NASH is a subset of NAFLD characterized by fatty change with lobular inflammation, hepatocellular injury, progressive fibrosis and cirrhosis. The bariatric surgery population is an ideal cohort to study a large subset of NASH; those with morbid obesity.
The purpose of this study is to examine variability of hepatic histology as well as expression of key metabolic genes in NAFLD/NASH patients undergoing bariatric surgery. Patients will undergo pre-operative laboratory testing, followed by intra-operative liver and fat biopsies. A 12-month follow up will consist of repeat liver biopsy and laboratory testing. We predict that histologic variability of inflammation and fibrosis in NASH is accompanied by differential gene expression. Furthermore, if this variability is pronounced, this will temper the reliance on percutaneous liver biopsy in NASH as the "gold standard" and further emphasize the need for global markers of disease progression.
- Conditions
- Obesity
- Keywords
- NAFLD, NASH, Obesity, Bariatric Surgery, Weight Reduction
- Medical subject headings
- Obesity, Non-alcoholic Fatty Liver Disease, Weight Loss
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2006 (estimated)
- Study startSep 2006
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mary Rinella, Northwestern University
- Investigators
- Mary E. Rinella, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00280527
- Sponsor's protocol ID
- 1347-004
- Status last verified
- Dec 2011
- First submitted
- 19 Jan 2006
- Last updated
- 20 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol for the Assessment of Variability in Histology and Gene Expression in Bariatric Surgery Patients.
- ClinicalTrials.gov ID
- NCT00280527
- Acronym / sponsor ID
- 1347-004
- Conditions
- Obesity
- Keywords
- NAFLD, NASH, Obesity, Bariatric Surgery, Weight Reduction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Sep 2006
- Study completion
- Sep 2008 (actual)
- First posted
- 23 Jan 2006 (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.
It is known that a vast majority of patients seeking a bariatric surgery weight reduction procedure have non-alcoholic fatty liver disease (NAFLD), while a smaller subset of patients within this group have a more serious liver problem known as nonalcoholic steatohepatitis (NASH). NASH is a serious liver disease that can lead to cirrhosis, liver failure and ultimately liver transplantation. The purpose of this study is to explore the effects of bariatric surgery on the progression of NASH. The investigators also hope to gain insight into which genes may be responsible for the development of NAFLD and NASH. The knowledge gained from this study will advance the field of fatty liver disease and help design rational treatments to prevent disease progression.
Detailed description
Nonalcoholic fatty liver disease (NAFLD) is the most common cause of abnormal liver tests in the United States. NAFLD is often found in association with obesity and diabetes and it is expected to become increasingly prevalent as the incidence of diabetes and obesity continues to increase. NAFLD represents a range of diseases from simple fatty deposition in the liver to more aggressive inflammation and fibrosis, termed nonalcoholic steatohepatitis (NASH). The distinction of NASH as an entity within NAFLD is an important one, as the natural history of this disease is different. Ultimately, NASH may progress to cirrhosis in up to 25% of patients, compared to simple steatosis which is a benign condition.
NAFLD has been estimated at 10-24% in various populations and is significantly higher in obese populations (57.5-74%). NASH is a subset of NAFLD characterized by fatty change with lobular inflammation, hepatocellular injury, progressive fibrosis and cirrhosis. The bariatric surgery population is an ideal cohort to study a large subset of NASH; those with morbid obesity.
The purpose of this study is to examine variability of hepatic histology as well as expression of key metabolic genes in NAFLD/NASH patients undergoing bariatric surgery. Patients will undergo pre-operative laboratory testing, followed by intra-operative liver and fat biopsies. A 12-month follow up will consist of repeat liver biopsy and laboratory testing. We predict that histologic variability of inflammation and fibrosis in NASH is accompanied by differential gene expression. Furthermore, if this variability is pronounced, this will temper the reliance on percutaneous liver biopsy in NASH as the "gold standard" and further emphasize the need for global markers of disease progression.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This will be a prospective trial of obese patients with presumed NAFLD undergoing bariatric surgery. Patients will be enrolled at Northwestern Memorial Hospital through the bariatric surgery clinic.
Key inclusion criteria (9 listed)
- Subjects must be willing to give written informed consent
- Subjects must fulfill the criteria for bariatric surgery that have been recommended by a National Institutes of Health (NIH) consensus conference.
- The patient should be greater than 100 pounds above desirable body weight or a Body Mass Index (BMI) >40 kg/m2.
- Presence of significant obesity-related illnesses with a BMI of 35-40 kg/m2.
- Failure of sustained weight loss on supervised dietary and/or medical regimens.
Key exclusion criteria (11 listed)
- Anti - smooth muscle Ab < 1:80.
- Serum Hepatitis B surface antigen (HepBsAg) negative.
- Serum Hepatitis C Antibody (HepC Ab) negative
- Iron/TIBC ratio (transferrin saturation) < 45%
- Alpha-1-antitrypsin level within normal limits
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
Not reported in the source record.
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 Dec 2011.
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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.
Mary E. Rinella, MD principal investigator
Northwestern University
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 Northwestern 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 9 inclusion and 11 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 Dec 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.
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 20 Dec 2011.