Metabolic SyndromeNCT01068535
Early Vascular Wall Changes by Magnetic Resonance Imaging (MRI) in Metabolic Syndrome Versus Metabolically Normal Pre-Menopausal Women: A Pilot Study
An observational study of Metabolic Syndrome, run by University of Washington at 1 site in United States.
Trial summary
The purpose of this study is to compare the vascular permeability of blood vessel walls (of the carotid artery) in pre-menopausal women who have metabolic syndrome (syndrome of having at least 3/5 following features- increased abdominal fat, low good cholesterol (HDL-C), elevated fasting blood fats (triglycerides)… Read more about this study
- Who is it for?
- Ages 35 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to Jul 2013
- 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 35 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pre-menopausal Women
Who may be able to join
- Pre-menopausal women (age 35-50)
- still having menstrual periods
Who cannot join
- History of diabetes mellitus
- History of cardiovascular disease (peripheral vascular disease, coronary artery disease, cerebrovascular disease)
- Serum creatinine >1.2 mg/dL (eGFR <60 ml/min.)
- Active rheumatologic disease
- Use of hormonal contraception*
- Pregnant or planning a pregnancy within the next 3 months
Show all 22Show fewer
- Fasting triglycerides ≥ 500 mg/dL
- Fasting LDL-C ≥ 190 mg/dL
- Currently taking lipid lowering medications*
- Currently taking vaso-active (blood pressure) medications*
- Hypertension: SBP ≥ 140 and or DBP ≥90 mm Hg
- Chronic use of aspirin (prn use is allowed)
- Chronic use of non-steroidal anti-inflammatory medications (prn use is allowed)
- Tobacco use within 3 months of starting study
- Participation in another clinical trial within the last 30 days
- MRI specific exclusion criteria:
- History of claustrophobia
- History of decrease in kidney function (eGFR <60 ml/min.)
- History of reaction to a contrast medium or dye used for an MRI, CT Scan, or X-ray
- History of significant anemia or other blood disease
- History of seizures
- MRI-incompatible metal such as internal metal hardware or devices * Drugs within the following classifications are exclusionary: Antilipemics, antilipidemics, beta blockers, ACE inhibitors, angiotensin receptor blockers, diuretics, calcium channel blockers, alpha blockers, nitrates, and all hormonal contraceptives
Trial locations and contacts
1 site in 1 country.
United States1 site
Harborview/University of Washington
Seattle, Washington, 98104
About this study
Official title: Early Vascular Wall Changes by MRI in Metabolic Syndrome vs. Metabolically Normal Pre-Menopausal Women: A Pilot Study
The purpose of this study is to compare the vascular permeability of blood vessel walls (of the carotid artery) in pre-menopausal women who have metabolic syndrome (syndrome of having at least 3/5 following features- increased abdominal fat, low good cholesterol (HDL-C), elevated fasting blood fats (triglycerides), elevated blood pressure, an elevated fasting glucose) versus those women who are normal weight and with normal cholesterol, blood fats, blood pressure, and blood sugar. We are using a novel technology to measure vascular permeability known as dynamic contrast enhancement magnetic resonance imaging (DCE-MRI). The primary variable is ktrans ratio which is a mathematically derived quantity obtained from DCE-MRI. We are trying to identify novel markers of early atherosclerosis in young women.
Read the detailed description
This study involves a phone screen \& 2 study visits:
- Screening visit, which includes a quick finger stick cholesterol, glucose, triglycerides test (cholestech) to determine qualification, waist measurement, weight. Results are provided regardless of qualification. If the volunteer qualifies, a full blood draw (approximately 45cc or 3 Tablespoons) will occur. A snack is provided once blood is drawn. Additional study visit procedures include a medical history questionnaire including menstrual history, height \& weight measurement, vital signs, and waist \& hip measurements. This study lasts up to 90 minutes.
- MRI visit (to occur within a week of screening visit) occurs once serum pregnancy \& creatinine results are received \& only if approved to continue by P.I. (e.g. negative serum pregnancy and eGFR>60). An IV catheter is placed in the antecubital vein to administer an injection of (gadolinium) contrast medium. A coil is placed on each side of the subject's neck while laying flat on a bench, with her upper body inside the MRI scanner. The entire MRI procedure takes approximately 60 minutes.
- Conditions
- Metabolic Syndrome
- Keywords
- metabolic syndrome, MetS, premenopausal women, vascular risk, atherosclerosis detection
- Medical subject headings
- Metabolic Syndrome
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 |
|---|---|---|
| Women with Metabolic Syndrome | Pre-menopausal women with Metabolic Syndrome Age 35-50 and any 3 of the following: Fasting triglycerides ≥ 150 mg/dL, Waist measurement ≥ 35 inches, HDL < 50mg/dL, Fasting glucose ≥ 100mg/dL but <126mg/dL or Blood pressure ≥ 130/85 or taking medication to treat high blood pressure. | |
| Non-Metabolic Syndrome (healthy) women | Non-Metabolic syndrome pre-menopausal women age 35-50 * Body Mass Index ≤ 25 * Regular menstrual cycles (occur every 24-35 days) * Fasting glucose < 100mg/dL * HDL-C ≥ 50mg/dL * Waist measurement ≤ 35 inches * Fasting triglycerides < 150mg/dL |
What is being measured
The primary outcome is the main question the study is designed to answer.
ktrans of the carotid artery wall
Ktrans is a transfer constant that is a measure of vascular permeability.
Measured: baseline
Secondary outcomes (1)
carotid artery intima-media thickness as measured by MRI
Carotid intima-media thickness is a measure of the actual thickness of the intima and media layers of the carotid artery wall.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2010 (estimated)
- Study startMay 2009
- Primary completionJul 2012
- Study completionJul 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pathmaja Paramsothy, M.D.,M.S., Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01068535
- Sponsor's protocol ID
- 35352-A
- Status last verified
- Sep 2012
- First submitted
- 11 Feb 2010
- Last updated
- 14 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Vascular Wall Changes by MRI in Metabolic Syndrome vs. Metabolically Normal Pre-Menopausal Women: A Pilot Study
- ClinicalTrials.gov ID
- NCT01068535
- Acronym / sponsor ID
- 35352-A
- Conditions
- Metabolic Syndrome
- Keywords
- metabolic syndrome, MetS, premenopausal women, vascular risk, atherosclerosis detection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2013 (estimated)
- First posted
- 15 Feb 2010 (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 compare the vascular permeability of blood vessel walls (of the carotid artery) in pre-menopausal women who have metabolic syndrome (syndrome of having at least 3/5 following features- increased abdominal fat, low good cholesterol (HDL-C), elevated fasting blood fats (triglycerides), elevated blood pressure, an elevated fasting glucose) versus those women who are normal weight and with normal cholesterol, blood fats, blood pressure, and blood sugar. We are using a novel technology to measure vascular permeability known as dynamic contrast enhancement magnetic resonance imaging (DCE-MRI). The primary variable is ktrans ratio which is a mathematically derived quantity obtained from DCE-MRI. We are trying to identify novel markers of early atherosclerosis in young women.
Detailed description
This study involves a phone screen \& 2 study visits:
- Screening visit, which includes a quick finger stick cholesterol, glucose, triglycerides test (cholestech) to determine qualification, waist measurement, weight. Results are provided regardless of qualification. If the volunteer qualifies, a full blood draw (approximately 45cc or 3 Tablespoons) will occur. A snack is provided once blood is drawn. Additional study visit procedures include a medical history questionnaire including menstrual history, height \& weight measurement, vital signs, and waist \& hip measurements. This study lasts up to 90 minutes.
- MRI visit (to occur within a week of screening visit) occurs once serum pregnancy \& creatinine results are received \& only if approved to continue by P.I. (e.g. negative serum pregnancy and eGFR>60). An IV catheter is placed in the antecubital vein to administer an injection of (gadolinium) contrast medium. A coil is placed on each side of the subject's neck while laying flat on a bench, with her upper body inside the MRI scanner. The entire MRI procedure takes approximately 60 minutes.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women with Metabolic Syndrome | – | –Pre-menopausal women with Metabolic Syndrome Age 35-50 and any 3 of the following: Fasting triglycerides ≥ 150 mg/dL, Waist measurement ≥ 35 inches, HDL < 50mg/dL, Fasting glucose ≥ 100mg/dL but <126mg/dL or Blood pressure ≥ 130/85 or taking medication to treat high blood pressure. |
| Non-Metabolic Syndrome (healthy) women | – | –Non-Metabolic syndrome pre-menopausal women age 35-50 * Body Mass Index ≤ 25 * Regular menstrual cycles (occur every 24-35 days) * Fasting glucose < 100mg/dL * HDL-C ≥ 50mg/dL * Waist measurement ≤ 35 inches * Fasting triglycerides < 150mg/dL |
Who may qualify
- Ages
- 35 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pre-menopausal Women
Key inclusion criteria (2 listed)
- Pre-menopausal women (age 35-50)
Key exclusion criteria (22 listed)
- History of diabetes mellitus
- History of cardiovascular disease (peripheral vascular disease, coronary artery disease, cerebrovascular disease)
- Serum creatinine >1.2 mg/dL (eGFR <60 ml/min.)
- Active rheumatologic disease
- Use of hormonal contraception*
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
ktrans of the carotid artery wall
Time frame: baseline
Ktrans is a transfer constant that is a measure of vascular permeability.
1 secondary outcome
carotid artery intima-media thickness as measured by MRI
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 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.
Pathmaja Paramsothy, M.D.,M.S. principal investigator
University of Washington
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 Metabolic Syndrome, run by University of Washington 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 22 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: status not confirmed, as of the sponsor's last update on 14 Sep 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?
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?
ktrans of the carotid artery wall (time frame: baseline). 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 14 Sep 2012.