Phase 4
N=47
Effects of Thiazide Diuretics on Sympathetic Nervous System in Hypertension
Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT00353652 ↗Enrolled (actual)
47
Serious AEs
0.0%
Results posted
Dec 2014
Primary outcome: Primary: Sympathetic Nerve Activity — 46; 40; 49; 42 bursts/min
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Study#1: chlorthalidone (CTD), titrated dose (Drug); Study #1: spironolactone (SP), titrated dose (Drug); Study# 2 chlorthalidone (CTD), fixed dose (Drug); Study# 2 spironolactone (SP), fixed dose (Drug); Study# 2 irbsesartan (IR), fixed dose (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Texas Southwestern Medical Center
- Primary completion
- Jan 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sympathetic Nerve Activity |
46; 40; 49; 42; 52 | — |
| SECONDARY 24-hour Ambulatory Systolic Blood Pressure |
127.4; 128.6; 123.5; 121.6; 119.8 | — |
| SECONDARY Insulin |
8.24; 7.6; 7.6; 4.87; 6.8 | — |
| SECONDARY HOMA-IR |
1.91; 1.33; 1.87; 0.85; 1.42 | — |
| SECONDARY Sympathetic Baroreflex Sensitivity |
-9.1; -15.2; -12.9; -11.3; -12.0 | — |
Summary
Thiazide medications are often prescribed for individuals with high blood pressure, but research has shown that they may increase an individual's risk of developing diabetes. While it is unknown exactly how thiazide causes this response, it is likely that the nervous system is somehow involved. This study will evaluate the role of the nervous system in sugar metabolism, as well as determine the effect of thiazide and other medications on individuals with high blood pressure.
Eligibility Criteria
Inclusion Criteria
- Untreated stage 1 primary hypertension (systolic blood pressure between 140 to 159 mm Hg and diastolic blood pressure between 90 to 99 mm Hg)
Exclusion Criteria
- Cardiopulmonary disease, as determined by medical history or by physical examination
- Serum creatinine greater than or equal to 1.5 mg/dL
- Diabetes mellitus or other systemic illness
- Left ventricular hypertrophy by echocardiography or ECG
- Hypersensitivity to chlorthalidone, spironolactone, eplerenone, angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blocker, insulin, Evans blue dye, or clonidine
- History of substance abuse (other than tobacco)
- History of gouty arthritis
- History of ACE inhibitor-induced cough or angioedema
- Evidence of secondary hypertension
- Pregnant
Data sourced from ClinicalTrials.gov (NCT00353652). 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.