HypertensionPhase 4MEADNCT00887510
Metabolic Effects of Antihypertensive Drugs on People With Metabolic Syndrome (The MEAD Study)
A Phase 4 study testing Hydrochlorothiazide and Trandolapril in people with Hypertension, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Hydrochlorothiazide and Trandolapril
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Nov 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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])
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Metabolic Effects of Antihypertensive Drugs
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.
Read the 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.
- Conditions
- Hypertension
- Being tested
- Hydrochlorothiazide, Trandolapril
- Keywords
- Metabolic Syndrome, High Blood Pressure, Abdominal Obesity, Impaired Glucose Tolerance
- Medical subject headings
- Hypertension, Metabolic Syndrome, Obesity, Abdominal, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydrochlorothiazideDrug
25 mg tablet once daily for 6 weeks
Other Names:
HCTZ
TrandolaprilDrug
4 mg tablet once daily for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Hydrochlorothiazide; Drug: Trandolapril |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Comparing the change in adiponectin: 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.
Measured: Over the course of 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2009 (estimated)
- Study startMay 2007
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Rhonda M. Cooper-DeHoff, Pharm D, MS, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00887510
- Sponsor's protocol ID
- 650
- Other IDs
- K23HL086558
- Acronym
- MEAD
- Status last verified
- Jun 2014
- First submitted
- 23 Apr 2009
- Last updated
- 17 Jun 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Effects of Antihypertensive Drugs
- ClinicalTrials.gov ID
- NCT00887510
- Acronym / sponsor ID
- MEAD / 650
- Conditions
- Hypertension
- Keywords
- Metabolic Syndrome, High Blood Pressure, Abdominal Obesity, Impaired Glucose Tolerance
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- May 2007
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 24 Apr 2009 (estimated)
- Results
- Posted 17 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thiazide First | Active comparator | Drug: Hydrochlorothiazide, Drug: TrandolaprilParticipants 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. |
| Trandolapril First | Active comparator | Drug: Hydrochlorothiazide, Drug: TrandolaprilParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydrochlorothiazide25 mg tablet once daily for 6 weeks Other Names: HCTZ | Drug | Thiazide First, Trandolapril First |
| Trandolapril4 mg tablet once daily for 6 weeks | Drug | Thiazide First, Trandolapril First |
Primary outcome
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
Time frame: OGTT AUC measured over 120 minutes after receiving study intervention for 18-24 weeks.
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.
1 secondary outcome
Change in Total Adiponectin Level After Addition of Trandolapril to HCTZ Compared With Change in Adiponectin After Addition of HCTZ to Trandolapril
Time frame: Over the course of 18 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rhonda M. Cooper-DeHoff, Pharm D, MS principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hydrochlorothiazide and Trandolapril in people with Hypertension, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: OGTT AUC measured over 120 minutes after receiving study intervention for 18-24 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2014.