ObesityNCT00858221
Association of Genes to Resistance to Weight Loss in Obese Patients
An observational study of Obesity and Metabolic Syndrome, run by Interleukin Genetics, Inc. at 1 site in United States.
Trial summary
The overall goal of this study is to determine whether variations in the perilipin, and several other, genes would be a useful tool for physicians who are caring for morbidly obese patients to guide therapy. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Obesity, Metabolic Syndrome, Dyslipidemia
- How many people
- 824 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Jul 2009
- 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 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Caucasian adults between the age of 21 and 70 years, inclusive, who fit the criteria for patients undergoing bariatric surgery at the Geisinger Clinic.
Who may be able to join
- Caucasian
- competent patients interested in Gastric Bypass Surgery
- patients who are eligible for Gastric Bypass Surgery based on NIH criteria:
- Male or Female
- 21 - 70 years old, inclusive
- Body Mass Index (BMI) > 40 with 2 co-morbid conditions such as Sleep Apnea, Hypertension, or Type 2 Diabetes
- BMI > 45 with no co-morbid conditions
Who cannot join
- Patients not interested in Gastric Bypass Surgery
- Patients who do not qualify for surgery based on medical contraindications
- Patients with severe psychological contraindications
- Patients not willing to be compliant with pre-post surgical recommendations
- Patients younger than 21 years of age
- Patients older than 70 years of age
Show all 10Show fewer
- Patients who do not qualify for surgery based on insurance constraints i.e., insurance guidelines for bypass surgery
- Patients who are pregnant
- Hispanic, Black, Asian Races
- Abnormal thyroid function
Trial locations and contacts
1 site in 1 country.
United States1 site
Geisinger Health System
Danville, Pennsylvania, 17822
About this study
Official title: Association of Genetic Variants in Obesity Genes to Resistance to Weight Loss and Susceptibility to Metabolic Syndrome in Morbidly Obese Patients: A Single Center, Blinded, Retrospective Clinical Study
The overall goal of this study is to determine whether variations in the perilipin, and several other, genes would be a useful tool for physicians who are caring for morbidly obese patients to guide therapy.
The main hypotheses to be tested is that sequence variations (polymorphisms) in the perilipin gene and several other obesity-related genes are associated with resistance to weight loss for obese individuals on energy restricted diets, potentially playing a role in the development of obesity related complications.
Read the detailed description
The PRIMARY goal of this study is to investigate the association of perilipin gene polymorphisms, with obese subjects who are "resistant" to weight loss in a defined program.
The SECONDARY goal of this study is to investigate if additional candidate obesity genes that have previously been associated with obesity or energy metabolism show association with resistance to weight loss in subjects on an energy restricted diet. Additionally, we would like to investigate if any metabolic syndrome parameters, such as dyslipidemia or abnormal fasting glucose are associated with perilipin or variations in other obesity-related genes.
- Conditions
- Obesity, Metabolic Syndrome, Dyslipidemia
- Keywords
- obesity, genes, polymorphisms, weight loss, haplotype, diplotype
- Medical subject headings
- Obesity, Metabolic Syndrome, Dyslipidemias, Weight Loss
What is being measured
The primary outcome is the main question the study is designed to answer.
Significant association of perilipin gene polymorphisms with obese subjects who are resistant to weight loss in a defined program.
Measured: 6 months
Secondary outcomes (1)
Significant association of other genes, known to be obesity-related, with resistance to weight loss. Also, association of primary and secondary gene SNPs with dyslipidemia.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2009 (estimated)
- Study startAug 2008
- Primary completionApr 2009
- Study completionJul 2009
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.
- 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
- Retrospective
- Enrolment
- 824 participants (actual)
Sponsor and investigators
- Lead sponsor
- Interleukin Genetics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Karen Shaver, MS, Study director, Interleukin GeneticsChristopher D. Still, MD, Principal investigator, Geisinger Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00858221
- Sponsor's protocol ID
- ILI-08-107PLIN
- Status last verified
- Oct 2009
- First submitted
- 5 Mar 2009
- Last updated
- 20 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Genetic Variants in Obesity Genes to Resistance to Weight Loss and Susceptibility to Metabolic Syndrome in Morbidly Obese Patients: A Single Center, Blinded, Retrospective Clinical Study
- ClinicalTrials.gov ID
- NCT00858221
- Acronym / sponsor ID
- ILI-08-107PLIN
- Conditions
- Obesity, Metabolic Syndrome, Dyslipidemia
- Keywords
- obesity, genes, polymorphisms, weight loss, haplotype, diplotype
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 824 participants (actual)
- Lead sponsor
- Interleukin Genetics, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 9 Mar 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 overall goal of this study is to determine whether variations in the perilipin, and several other, genes would be a useful tool for physicians who are caring for morbidly obese patients to guide therapy.
The main hypotheses to be tested is that sequence variations (polymorphisms) in the perilipin gene and several other obesity-related genes are associated with resistance to weight loss for obese individuals on energy restricted diets, potentially playing a role in the development of obesity related complications.
Detailed description
The PRIMARY goal of this study is to investigate the association of perilipin gene polymorphisms, with obese subjects who are "resistant" to weight loss in a defined program.
The SECONDARY goal of this study is to investigate if additional candidate obesity genes that have previously been associated with obesity or energy metabolism show association with resistance to weight loss in subjects on an energy restricted diet. Additionally, we would like to investigate if any metabolic syndrome parameters, such as dyslipidemia or abnormal fasting glucose are associated with perilipin or variations in other obesity-related genes.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Caucasian adults between the age of 21 and 70 years, inclusive, who fit the criteria for patients undergoing bariatric surgery at the Geisinger Clinic.
Key inclusion criteria (7 listed)
- Caucasian
- competent patients interested in Gastric Bypass Surgery
- patients who are eligible for Gastric Bypass Surgery based on NIH criteria:
Key exclusion criteria (10 listed)
- Patients not interested in Gastric Bypass Surgery
- Patients who do not qualify for surgery based on medical contraindications
- Patients with severe psychological contraindications
- Patients not willing to be compliant with pre-post surgical recommendations
- Patients younger than 21 years of age
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
Significant association of perilipin gene polymorphisms with obese subjects who are resistant to weight loss in a defined program.
Time frame: 6 months
1 secondary outcome
Significant association of other genes, known to be obesity-related, with resistance to weight loss. Also, association of primary and secondary gene SNPs with dyslipidemia.
Time frame: 6 months
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 Oct 2009.
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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.
Karen Shaver, MS study director
Interleukin Genetics
Christopher D. Still, MD principal investigator
Geisinger Clinic
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 Metabolic Syndrome, run by Interleukin Genetics, Inc. 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 7 inclusion and 10 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 Oct 2009. 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?
Significant association of perilipin gene polymorphisms with obese subjects who are resistant to weight loss in a defined program. (time frame: 6 months). 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 20 Oct 2009.