Phase 4
N=24
Metabolic Effects of Antihypertensive Drugs on People With Metabolic Syndrome (The MEAD Study)
Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT00887510 ↗Enrolled (actual)
24
Serious AEs
4.2%
Results posted
Jun 2014
Primary outcome: Primary: Change in Oral Glucose Tolerance Test (OGTT) Area Under Curve (AUC) After Addition of Trandolapril to Hydrochlorothiazide (HCTZ) Compared With Change in OGTT AUC After Addition of HCTZ to Trandolapril — -472; 1571 minutes*mg/dl
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Hydrochlorothiazide (Drug); Trandolapril (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Florida
- Primary completion
- Nov 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Oral Glucose Tolerance Test (OGTT) Area Under Curve (AUC) After Addition of Trandolapril to Hydrochlorothiazide (HCTZ) Compared With Change in OGTT AUC After Addition of HCTZ to Trandolapril |
-472; 1571 | — |
| SECONDARY Change in Total Adiponectin Level After Addition of Trandolapril to HCTZ Compared With Change in Adiponectin After Addition of HCTZ to Trandolapril |
-1.36; 0.42 | — |
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:
- Abdominal obesity, defined as a waist circumference greater than 40 inches in men and greater than 35 inches in women
- High-density lipoprotein (HDL) cholesterol level of less than 40 mg/dL in men and less than 50 mg/dL in women
- Fasting triglycerides greater than or equal to 150 mg/dL
- 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])
Data sourced from ClinicalTrials.gov (NCT00887510). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.