A Randomized Clinical Trial To Study Losartan On Endothelial Dysfunction and Insulin Resistance In Obese Patients
Information source: Brigham and Women's Hospital
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Obesity; Hypertension; Impaired Fasting Glucose
Intervention: losartan (Drug); Placebo control (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Brigham and Women's Hospital Official(s) and/or principal investigator(s):
Mark A Creager, MD, Principal Investigator, Affiliation: Brigham and Women's Hospital
Summary
The main purposes of this study are to find out if the study drug losartan (Cozaar) or
placebo ("sugar pill") has an effect on insulin sensitivity (how your body responds to
insulin) and to measure the effect of the study drug losartan or placebo on how the arteries
in your arm dilate (enlarge to carry more blood).
We hope to learn if taking losartan changes the amount of certain proteins in the blood that
effect blood vessel function.
Losartan is approved by the US FDA to treat high blood pressure. It will take approximately 4
months for you to complete this study.
Clinical Details
Official title: Protocol Merck 318-00: A Double-Blind, Placebo-Controlled, Randomized, Parallel, Clinical Trial To Study The Effect Of Losartan Potassium On Endothelial Dysfunction And Insulin Resistance In Obese Patients With Impaired Fasting Glucose
Study design: Other, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Assess the effect of Losartan 100mg on insulin sensitivity utilizing the euglycemic hyperinsulinemic clamp and the effect on endothelial function as assessed by pulse volume amplitude measured by change from baseline after 8 weeks of treatment
Secondary outcome: To evaluate the change from baseline cytokines, markers of inflammation, and markers of oxidative stress after 8 weeks of treatment. Also to evaluate the effect on microalbuminuria after 8 weeks of treatment.
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Currently taking 1 or no antihypertensive medication
- Male and female between 18 and 75 years of age
- Mean trough SiDBP ≥80 and < 100 mm Hg
- Mean trough SiSBP ≥120 and <160 mm Hg
- Non-diabetic patients with fasting plasma glucose ≥100 mg/dL and <126 mg/dL
- BMI >30 and <40
- Waist circumference >40 inches in males, > 35 inches in females
- A patient who is of reproductive potential and agrees to remain abstinent or use
acceptable methods of birth control (IUD, diaphragm with spermicide, contraceptive
sponge, condom, hormonal contraception, vasectomy) within the projected duration of
the study
Exclusion Criteria:
- Secondary hypertension of any etiology (renal artery stenosis, coarctation of the
aorta or pheochromocytoma, hypertension induced by oral contraceptives)
- History of malignant hypertension
- Any clinically significant renal disease including single functioning kidney, and
known history of anuria. Any severe renal impairment, as manifested by serum
creatinine more than 1. 5 mg/dL, or proteinuria >2+ by urine dipstick
- Known sensitivity or intolerance to angiotensin II receptor antagonists
- Type I or II diabetes
- Inability or unwillingness to abstain from taking prohibited medications during the
study period
- History of MI, PCI, CABG, CHF, unstable angina, TIA, or CVA
- Concomitant cardiac conditions that would make it unsafe to participate in the trial
(e. g., clinically significant AV conduction disturbance, atrial flutter, atrial
fibrillation, potentially life-threatening ventricular arrhythmias, decompensated
valvular disease, presence of hemodynamically significant obstructive valvular
disease, or cardiomyopathy)
- History of angioedema and/or organ damage from hypertension
- Serum potassium < 3. 5 or > 5. 5 mEq/L
- Any clinically significant laboratory value which in the investigator's judgment could
be clinically significant to the outcome of this study.
- History of clinically important gastrointestinal resection or malabsorption
- Patient with a history or current evident of any condition, therapy, lab abnormality,
or other circumstance that might confound the results of the study, or interfere with
the patient's participation for the full duration of the study, such that it is not in
the best interest of the patient to participate. (Including but not limited to: recent
or current alcoholism, drug abuse within the prior 2 years, mental or legal
incapacitation, any disease which could reasonably be expected to be fatal or
life-threatening, or a history of malignancy ≤ 5 years prior to signing informed
consent.)
- Currently participating or has participated in a study with an investigational
compound or device within 30 days of signing informed consent.
- Inability to be taken off all current antihypertensive medication and placed on
placebo for up to 12 weeks.
- Unwillingness or unlikely to adhere to the study procedures, keep appointments, or is
planning to relocate during the study.
- Arm circumference great than 52 cm
- Smokers or former smokers who have quite less than 1 year prior to Visit 1
- Anemia (Hemoglobin < 11)
- Allergy to latex
- Deformed hands and/or fingers that would interfere with the collection of pulse volume
amplitude measurements
- History of Raynaud's disease or any other vascular condition
- Bilateral mastectomy
- Aortic stenosis
- Patient is taking high doses of antioxidant supplements (vitamins, minerals, or
other)
Locations and Contacts
CAVS Clinical Research Center, Little Rock, Arkansas 72205, United States; Recruiting
Angie Smither, Phone: 501-257-5882, Email: smithangelaa@uams.edu
Neda Rasouli, MD, Principal Investigator
VA San Diego Health Care System, San Diego, California 92161, United States; Recruiting
Adrienne Armstrong, Phone: 858-552-8585, Ext: 2884, Email: adriennearmstrong@sbcglobal.net
Robert Henry, MD, Principal Investigator
University of Miami Diabetes Research Institute, Miami, Florida 33136, United States; Recruiting
Robert Agramonte, Phone: 305-243-6573, Email: ragramon@med.miami.edu
Jennifer Marks, MD, Principal Investigator
Indiana University School of Medicine, Indianapolis, Indiana 46202, United States; Recruiting
Robin Chisolm, Phone: 317-274-7679, Email: rlchiso@iupui.edu
Kieren Mather, MD, Principal Investigator
Brigham and Women's Hospital Cardiovascular Division, Boston, Massachusetts 02115, United States; Recruiting
Jeanne Doyle, BS, RN, BC, Phone: 617-525-7055, Email: jdoyle7@partners.org
Nicole Navarrete, Phone: 617-525-7055, Email: nnavarrete@partners.org
Mark A Creagear, MD, Principal Investigator
St. Lukes Roosevelt Hospital, New York, New York 10025, United States; Recruiting
Sylvaine Frances, Phone: 212-523-4572, Email: sfrancis@chpnet.org
Jeannine Albu, MD, Principal Investigator
University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania 19104, United States; Recruiting
Carissa Fuller, Phone: 215-746-2084, Email: Carissa.Fuller@uphs.upenn.edu
Michael Rickels, MD, Principal Investigator
University of Texas SW Medical Center at Dallas, Dallas, Texas 75390, United States; Recruiting
Thanalakshmi Seenivasan, Phone: 214-648-9705, Email: Thanalakshmi.Seenivasan@UTSouthwestern.edu
Scott Grundy, MD, Principal Investigator
Hypertension Clinical Pharmacology Baylor Clinic, Houston, Texas 77030, United States; Recruiting
Charlyne Wright, Phone: 713-798-2375, Email: cwright@bcm.tmc.edu
James Pool, MD, Principal Investigator
Additional Information
Starting date: May 2007
Ending date: July 2008
Last updated: May 9, 2008
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