A Randomized Clinical Trial To Study Losartan On Endothelial Dysfunction and Insulin Resistance In Obese Patients

Mass General Brigham

Status and phase

Completed

Phase 4

Conditions

Hypertension

Hyperglycemia

Obesity

Treatments

Drug: losartan

Drug: Placebo control

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00675987

2007-P-000490

Details and patient eligibility

About

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.

Enrollment

53 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Currently taking 1 or no antihypertensive medication
Male and female between 18 and 75 years of age
Mean trough sitting diastolic blood pressure (SiDBP) ≥80 and < 100 mm Hg
Mean trough sitting systolic blood pressure (SiSBP) ≥120 and <160 mm Hg
Non-diabetic patients with fasting plasma glucose ≥100 mg/dL and <126 mg/dL
Body mass index (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 (intrauterine device (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 myocardial infarction (MI), percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG), congestive heart failure (CHF), unstable angina, transient ischemic attack (TIA), or cerebrovascular accident (CVA)
Concomitant cardiac conditions that would make it unsafe to participate in the trial (e.g., clinically significant atrioventricular (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)