Metabolic Effects of Antihypertensive Drugs on People With Metabolic Syndrome (The MEAD Study)

NCT00887510 | Completed Phase 4 Results

• 2 other identifiers: 650K23HL086558
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypertension

Keywords

Metabolic Syndrome; High Blood Pressure; Abdominal Obesity; Impaired Glucose Tolerance

Outcome Measures

Primary Outcomes (1)

• 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

  Comparing the change in OGTT AUC rand 1 visit4-visit 3 with rand 2 visit 3-2. This allows for understanding the effects of addition of trandolapril to 12 weeks of HCTZ compared with addition of HCTZ to 12 weeks of trandolapril. This is the primary outcome of the study.

  OGTT AUC measured over 120 minutes after receiving study intervention for 18-24 weeks.

Secondary Outcomes (1)

• Change in Total Adiponectin Level After Addition of Trandolapril to HCTZ Compared With Change in Adiponectin After Addition of HCTZ to Trandolapril

  Over the course of 18 weeks

Study Arms (2)

Thiazide First

ACTIVE COMPARATOR

Participants will receive 25 mg of hydrochlorothiazide (HCTZ) each day for 6 weeks, followed by 25 mg of HCTZ every day plus 4 mg of trandolapril each day for 6 weeks, followed by 4 mg trandolapril each day for 6 weeks.

Drug: Hydrochlorothiazide; Drug: Trandolapril

Trandolapril First

ACTIVE COMPARATOR

Participants will receive 4 mg of trandolapril each day for 6 weeks, followed by 4 mg of trandolapril for 6 weeks plus 25 mg of HCTZ each day for 6 weeks, followed by 25 mg of HCTZ each day for 6 weeks.

Drug: Hydrochlorothiazide; Drug: Trandolapril

Interventions

Hydrochlorothiazide DRUG

25 mg tablet once daily for 6 weeks Other Names: HCTZ

Thiazide First; Trandolapril First

Trandolapril DRUG

4 mg tablet once daily for 6 weeks

Thiazide First; Trandolapril First

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 \[ARBs\])

Sponsors & Collaborators

• University of Florida: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Hypertension; Metabolic Syndrome; Obesity, Abdominal; Glucose Intolerance

Interventions

Hydrochlorothiazide; trandolapril

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperglycemia

Intervention Hierarchy (Ancestors)

Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Rhonda M Cooper-DeHoff
• Organization: University of Florida

dehoff@cop.ufl.edu

352 273-6184

Study Officials

• Rhonda M. Cooper-DeHoff, Pharm D, MS

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2009
• First Posted: April 24, 2009
• Study Start: May 1, 2007
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: June 17, 2014
• Results First Posted: June 17, 2014

Record last verified: 2014-06

Locations

US (1)