Metabolic Effects of Antihypertensive Drugs on People With Metabolic Syndrome (The MEAD Study)
Condition: Hypertension
MeSH terms: Metabolic Syndrome
Intervention: Hydrochlorothiazide; Trandolapril
Intervention description: 25 mg tablet once daily for 6 weeks
Other Names:
HCTZ; 4 mg tablet once daily for 6 weeks
Intervention MeSH terms: Hydrochlorothiazide; Trandolapril
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Metabolic Syndrome; High Blood Pressure; Abdominal Obesity; Impaired Glucose Tolerance

Summary:

      High blood pressure, also referred to as hypertension, is a blood pressure level of 140/90 mm
      Hg or higher. Along with lifestyle changes, various medications are currently used to treat
      people with hypertension. Some of these medications, however, may affect the way the body
      handles sugar, essentially preventing the body from breaking down sugar and predisposing
      people to developing diabetes. People who have metabolic syndrome-a condition primarily
      characterized by an increased waist measurement, abnormal blood lipid levels, hypertension,
      and high blood sugar levels-are already at risk of developing diabetes. In these people,
      taking the antihypertensive medications that prevent sugar breakdown may further increase
      their risk of diabetes. The purpose of this study is to gain an understanding of how people
      with metabolic syndrome respond to antihypertensive medications that alter the body's ability
      to break down sugar.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Hypertension, defined as systolic blood pressure greater than or equal to 130 but less
             than 160 mm Hg and diastolic blood pressure greater than or equal to 85 but less than
             110 mm Hg

          -  Must have any two of the following criteria:

               1. Abdominal obesity, defined as a waist circumference greater than 40 inches in men
                  and greater than 35 inches in women

               2. High-density lipoprotein (HDL) cholesterol level of less than 40 mg/dL in men and
                  less than 50 mg/dL in women

               3. Fasting triglycerides greater than or equal to 150 mg/dL

               4. Fasting glucose level of 100-125 mg/dL

        Exclusion Criteria:

          -  Significant hypertension (greater than 160/110 mm Hg)

          -  Isolated systolic hypertension

          -  Diseases requiring treatment with diuretics or angiotensin-converting enzyme (ACE)
             inhibitors

          -  Cardiovascular disease (history of heart attack, stroke, heart failure)

          -  Hypersensitivity to HCTZ or ACE inhibitor

          -  Type 1 or type 2 diabetes

          -  Hypokalemia

          -  Peri-menopause (symptom onset within 1 year)

          -  Pregnant or breastfeeding

          -  Secondary causes of hypertension

          -  Current use of antihypertensive medications known to affect glucose homeostasis (e.g.,
             diuretics, beta blockers, corticosteroids, ACE inhibitors, angiotensin receptor
             blockers [ARBs])