Metabolic Effects of Antihypertensive Drugs on People With Metabolic Syndrome (The MEAD Study)
Condition: Hypertension
MeSH terms: Metabolic Syndrome
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      Treatment for hypertension includes lifestyle changes and medications. Examples of some
      antihypertensive medications include diuretics, beta-blockers, angiotensin-converting enzyme
      (ACE) inhibitors, angiotensin receptor blockers (ARBs), and vasodilators. Mounting research
      suggests that certain antihypertensive medications, such as thiazide diuretics, are
      associated with metabolic disturbances that result in increased glucose intolerance, while
      other antihypertensive medications, such as ACE inhibitors and ARBs, appear to improve
      insulin sensitivity and glucose metabolism. The influence of these medications may be
      especially critical in people with metabolic syndrome, who are already at risk of developing
      glucose intolerance and 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. The long-term goal of the study is to determine the best
      antihypertensive medications for people who have both metabolic syndrome and hypertension so
      as to prevent or delay the onset of diabetes in this population.

      Participation in this study will last 18 weeks and involve four study visits. Participants
      will be randomly assigned to initially receive 6 weeks of treatment with either
      hydrochlorothiazide (HCTZ), which is a thiazide diuretic, or trandolapril, which is an ACE
      inhibitor. Both medications are FDA-approved for treating hypertension. After 6 weeks of
      treatment, if participants' blood pressure levels are not too low, they will add the second
      medication so that they are taking both HCTZ and trandolapril for the next 6 weeks, until
      Week 12. At Week 12, again if participants' blood pressure levels are not too low, they will
      then take only the second medication for the last 6 weeks. The four study visits will occur
      at baseline and after each of the three 6-week treatment periods (Weeks 6, 12, and 18). All
      study visits will include blood pressure and pulse measurements, urine and blood sampling,
      oral glucose tolerance testing, and questions about diet and exercise habits. The first and
      last study visits will also include a physical examination and a medical history review. Some
      of the blood collected during the first study visit will be used for genetic testing. There
      will be no follow-up visits.
    

Intervention name(s): Hydrochlorothiazide; Trandolapril
Intervention type(s): Drug; Drug
Intervention description(s): 25 mg tablet once daily for 6 weeks
Other Names:
HCTZ; 4 mg tablet once daily for 6 weeks
Intervention MeSH terms: Hydrochlorothiazide; Trandolapril
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Metabolic Syndrome; High Blood Pressure; Abdominal Obesity; Impaired Glucose Tolerance