PsoriasisNCT01856647
Pilot Study Characterizing Adipose Tissue Leukocytes by Flow Cytometry/Microscopy in Lean, Obese and Psoriatic Subjects
An observational study of Psoriasis and Obesity, run by Rockefeller University at 1 site in United States.
Trial summary
Obesity is an insulin resistance-associated metabolic disorder which is a hallmark of and risk factor for type 2 diabetes and the metabolic syndrome, often linked to cardiovascular disease, certain cancers and inflammatory diseases.The phenotyping of subcutaneous adipose tissue (SAT) hematopoetic cells from obese… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- What is being tested?
- Adipose tissue biopsy (fat biopsy)
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Dec 2015
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Obesity and psoriasis are characterized by infiltration of inflammatory cells (leukocytes) in SAT and skin, respectively. We expect that SAT in obese psoriasis subjects will have infiltrating inflammatory leukocytes because of obesity, and that these infiltrating leukocytes might be different and/or increased in numbers by the pathology of psoriasis
Who may be able to join
- Psoriatic lean cohort (BMI between 18-24.9 Kg/m2): moderate to severe plaque-type, at least 5% of BSA
- Psoriatic obese cohort (BMI between 30-40 Kg/m2): moderate to severe plaque-type, at least 5% of BSA
- Lean/non-psoriatic cohort: BMI between 18-24.9 Kg/m2
- Overweight/obese non-psoriatic cohort: BMI between 30-40 Kg/m2
- Subjects must be 18-65 years of age
Who cannot join
- Having received any systemic treatment for psoriasis within the last 30 days
- history of bleeding disorder
- weight loss of 10 pounds in the last four weeks
- current smoker
- Known diagnosis of any unrelated autoimmune disease or inflammatory disease ( i.e. lupus, atopic dermatitis, rheumatoid arthritis).
- Currently taking NSAIDS, aspirin, (if > once a week, stopped <30 days ago). Aspirin 81mg may be permitted if the Framingham Risk Score is < 10
Show all 19Show fewer
- Having received any anti-inflammatory medication within the last 30 days
- Current use of any anti-coagulants
- LFTs > 2 x upper normal limits
- HIV infection
- Pregnant
- Less than 6 weeks post partum
- history of cardiovascular disease (MI, CHF, CVA)
- Any cancer diagnosis within the last 5 years
- Symptoms of acute illness such as upper respiratory infection, bronchitis, gastroenteritis, or fever within 3 days of Visit 1
- Any medical, psychological or social condition that, in the opinion of the Investigator, would jeopardize the health or well-being of the participant during any study procedures or the integrity of the data
- ingestion of DHA or fish oil within last 90 days
- hypertension as defined as > 140 systolic and > 90 diastolic after 10 minutes of resting on 2 antihypertensives
- Use of statins within the last 30 days
Trial locations and contacts
1 site in 1 country.
United States1 site
The Rockefeller University
New York, New York, 10065
About this study
Official title: A Pilot Study to Characterize Adipose Tissue Leukocytes by Flow Cytometry and Microscopy in Lean, Obese and Psoriatic Subjects (Lean/Obese)
Obesity is an insulin resistance-associated metabolic disorder which is a hallmark of and risk factor for type 2 diabetes and the metabolic syndrome, often linked to cardiovascular disease, certain cancers and inflammatory diseases.The phenotyping of subcutaneous adipose tissue (SAT) hematopoetic cells from obese subjects by flow cytometry, microscopy and gene expression will enable us to identify inflammation in this tissue and may help us to understand the causes and consequences of obesity in order to determine how these cells might be implicated in the initiation and/or progression of the aforementioned diseases.
Read the detailed description
Obesity is an insulin resistance-associated metabolic disorder which is a hallmark of and risk factor for type 2 diabetes and the metabolic syndrome. It is also often linked to cardiovascular disease, certain cancers (e.g., colorectal, esophageal, endometrial, and ovarian), and inflammatory diseases (e.g., psoriasis, osteoarthritis,inflammatory bowel disease).The phenotyping of subcutaneous adipose tissue (SAT) hematopoetic cells from obese subjects by flow cytometry, microscopy and gene expression will enable us to identify inflammation in this tissue and may help us to understand the causes and consequences of obesity in order to determine how these cells might be implicated in the initiation and/or progression of the aforementioned diseases.
- Being tested
- Adipose tissue biopsy (fat biopsy)
- Keywords
- Psoriasis, Obesity
- Medical subject headings
- Psoriasis, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adipose tissue biopsy (fat biopsy)Procedure or surgery
An adipose tissue biopsy will be performed after a 10-12 hour overnight fast. A small sample of fat tissue will be removed from the subject for gene expression analysis. A subcutaneous fat biopsy (~3 ml) will be obtained from the lower abdomen following local anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| lean (BMI≤ 24.9 Kg/m2) | Adipose tissue biopsy (fat biopsy) in 9 lean (BMI≤ 24.9 Kg/m2) Receives: Procedure: Adipose tissue biopsy (fat biopsy) | |
| obese (BMI= 30-40 Kg/m2) | 9 obese (BMI= 30-40 Kg/m2) Receives: Procedure: Adipose tissue biopsy (fat biopsy) | |
| psoriatic lean | 9 psoriatic lean Receives: Procedure: Adipose tissue biopsy (fat biopsy) | |
| psoriatic obese | 9 psoriatic obese Receives: Procedure: Adipose tissue biopsy (fat biopsy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarkers for phenotyping a new type of leukocyte
Biomarkers for phenotyping a new type of leukocyte
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2013 (estimated)
- Study startFeb 2013
- Primary completionDec 2015
- Study completionDec 2015
Why it stopped: Low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies 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
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rockefeller University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Juana Gonzalez, Principal investigator, Rockefeller Univesrity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01856647
- Sponsor's protocol ID
- JUG-0799
- Status last verified
- Dec 2015
- First submitted
- 14 May 2013
- Last updated
- 21 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Characterize Adipose Tissue Leukocytes by Flow Cytometry and Microscopy in Lean, Obese and Psoriatic Subjects (Lean/Obese)
- ClinicalTrials.gov ID
- NCT01856647
- Acronym / sponsor ID
- JUG-0799
- Keywords
- Psoriasis, Obesity
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Low enrollment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Rockefeller UniversityUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 17 May 2013 (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.
Obesity is an insulin resistance-associated metabolic disorder which is a hallmark of and risk factor for type 2 diabetes and the metabolic syndrome, often linked to cardiovascular disease, certain cancers and inflammatory diseases.The phenotyping of subcutaneous adipose tissue (SAT) hematopoetic cells from obese subjects by flow cytometry, microscopy and gene expression will enable us to identify inflammation in this tissue and may help us to understand the causes and consequences of obesity in order to determine how these cells might be implicated in the initiation and/or progression of the aforementioned diseases.
Detailed description
Obesity is an insulin resistance-associated metabolic disorder which is a hallmark of and risk factor for type 2 diabetes and the metabolic syndrome. It is also often linked to cardiovascular disease, certain cancers (e.g., colorectal, esophageal, endometrial, and ovarian), and inflammatory diseases (e.g., psoriasis, osteoarthritis,inflammatory bowel disease).The phenotyping of subcutaneous adipose tissue (SAT) hematopoetic cells from obese subjects by flow cytometry, microscopy and gene expression will enable us to identify inflammation in this tissue and may help us to understand the causes and consequences of obesity in order to determine how these cells might be implicated in the initiation and/or progression of the aforementioned diseases.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| lean (BMI≤ 24.9 Kg/m2) | – | Procedure: Adipose tissue biopsy (fat biopsy)Adipose tissue biopsy (fat biopsy) in 9 lean (BMI≤ 24.9 Kg/m2) |
| obese (BMI= 30-40 Kg/m2) | – | Procedure: Adipose tissue biopsy (fat biopsy)9 obese (BMI= 30-40 Kg/m2) |
| psoriatic lean | – | Procedure: Adipose tissue biopsy (fat biopsy)9 psoriatic lean |
| psoriatic obese | – | Procedure: Adipose tissue biopsy (fat biopsy)9 psoriatic obese |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Obesity and psoriasis are characterized by infiltration of inflammatory cells (leukocytes) in SAT and skin, respectively. We expect that SAT in obese psoriasis subjects will have infiltrating inflammatory leukocytes because of obesity, and that these infiltrating leukocytes might be different and/or increased in numbers by the pathology of psoriasis
Key inclusion criteria (5 listed)
- Psoriatic lean cohort (BMI between 18-24.9 Kg/m2): moderate to severe plaque-type, at least 5% of BSA
- Psoriatic obese cohort (BMI between 30-40 Kg/m2): moderate to severe plaque-type, at least 5% of BSA
- Lean/non-psoriatic cohort: BMI between 18-24.9 Kg/m2
- Overweight/obese non-psoriatic cohort: BMI between 30-40 Kg/m2
- Subjects must be 18-65 years of age
Key exclusion criteria (19 listed)
- Having received any systemic treatment for psoriasis within the last 30 days
- history of bleeding disorder
- weight loss of 10 pounds in the last four weeks
- current smoker
- Known diagnosis of any unrelated autoimmune disease or inflammatory disease ( i.e. lupus, atopic dermatitis, rheumatoid arthritis).
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 |
|---|---|---|
| Adipose tissue biopsy (fat biopsy)An adipose tissue biopsy will be performed after a 10-12 hour overnight fast. A small sample of fat tissue will be removed from the subject for gene expression analysis. A subcutaneous fat biopsy (~3 ml) will be obtained from the lower abdomen following local anesthesia. | Procedure or surgery | lean (BMI≤ 24.9 Kg/m2), obese (BMI= 30-40 Kg/m2), psoriatic lean, psoriatic obese |
Primary outcome
Biomarkers for phenotyping a new type of leukocyte
Time frame: 5 years
Biomarkers for phenotyping a new type of leukocyte
Results and safety
The study was stopped early (reason given: Low enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 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.
Juana Gonzalez principal investigator
Rockefeller Univesrity
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 Psoriasis and Obesity, run by Rockefeller 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 5 inclusion and 19 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: stopped early, as of the sponsor's last update on 21 Dec 2015. 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 was stopped early (reason given: Low enrollment). Results are not available in the source record.
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?
Biomarkers for phenotyping a new type of leukocyte (time frame: 5 years). 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 21 Dec 2015.