Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00353652
Status:
COMPLETED
Last Update Posted:
2019-02-06
First Post:
2006-07-18
Brief Title:
Effects of Thiazide Diuretics on Sympathetic Nervous System in Hypertension
Sponsor:
University of Texas Southwestern Medical Center
Organization:
University of Texas Southwestern Medical Center
Study Overview
Official Title:
Neural Mechanisms of Thiazide-induced Insulin Resistance
Status:
COMPLETED
Status Verified Date:
2019-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Thiazide medications are often prescribed for individuals with high blood pressure but research has shown that they may increase an individuals 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
Detailed Description:
Thiazide medications including chlorthalidone are commonly prescribed for individuals with high blood pressure because they are inexpensive effective at lowering blood pressure and able to reduce the risk of heart failure and stroke Despite these advantages research has shown that thiazide medications may increase an individuals risk of developing diabetes The exact mechanism that causes this remains unknown Thiazide appears to increase sympathetic nervous system activity thereby decreasing glucose reuptake and metabolism by skeletal muscle tissues In turn this tends to contribute to glucose intolerance and the development of diabetes More research however is needed to confirm this link Spironolactone another blood pressure medication does not pose the same risk for developing diabetes and may prove beneficial as a primary treatment for high blood pressure The purpose of this study is to determine the role of the sympathetic nervous system in glucose metabolism in individuals with high blood pressure as well as compare the effectiveness of thiazide spironolactone and other antihypertensive medications in reducing blood pressure Results from this study may initiate the development of future clinical trials involving spironolactone as a primary treatment for reducing blood pressure
This study will enroll individuals with high blood pressure Study 1 All subjects were randomized to receive 3 months chlorthalidone 125-25 mgd or spironolactone 50-75 mgd using a single-blind 2-phase crossover design without washout between treatments Each subject was followed every 4 wk for measurement of 24-h ambulatory BP and serum potassium K The doses of chlorthalidone and spironolactone were titrated to achieve 24-h ambulatory BP of less than 13080mmHg in the same subject During chlorthalidone treatment period subject was given oral K supplementation according to a sliding scale to maintain serum K from 40-45 mmolliter Then sympathetic nerve activity SNA is measured after 3 months of chlorthalidone and after 3 months of spironolactone Arterial baroreflex sensitivity glucose and insulin are measured at baseline after 3 months of chlorthalidone and after 3 months of spironolactone Insulin sensitivity will be measured using HOMA-IR Study 2 All subjects are randomized to 3 months of fixed-dose Chlorthalidone 25 mg once daily alone fixed-dose Chlorthalidone 25 mg once daily plus fixed-dose Spironolactone 25 mg once daily and fixed-dose Chlorthalidone 25 mg once daily plus fixed-dose Irbesartan 150 mg once daily using a single-blind 3-phase crossover design without washout between treatments Then SNA Arterial baroreflex sensitivity glucose and insulin are measured after 3 months of each treatment phase
This study will enroll individuals with high blood pressure Study 1 All subjects were randomized to receive 3 months chlorthalidone 125-25 mgd or spironolactone 50-75 mgd using a single-blind 2-phase crossover design without washout between treatments Each subject was followed every 4 wk for measurement of 24-h ambulatory BP and serum potassium K The doses of chlorthalidone and spironolactone were titrated to achieve 24-h ambulatory BP of less than 13080mmHg in the same subject During chlorthalidone treatment period subject was given oral K supplementation according to a sliding scale to maintain serum K from 40-45 mmolliter Then sympathetic nerve activity SNA is measured after 3 months of chlorthalidone and after 3 months of spironolactone Arterial baroreflex sensitivity glucose and insulin are measured at baseline after 3 months of chlorthalidone and after 3 months of spironolactone Insulin sensitivity will be measured using HOMA-IR Study 2 All subjects are randomized to 3 months of fixed-dose Chlorthalidone 25 mg once daily alone fixed-dose Chlorthalidone 25 mg once daily plus fixed-dose Spironolactone 25 mg once daily and fixed-dose Chlorthalidone 25 mg once daily plus fixed-dose Irbesartan 150 mg once daily using a single-blind 3-phase crossover design without washout between treatments Then SNA Arterial baroreflex sensitivity glucose and insulin are measured after 3 months of each treatment phase
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL078782-02 | NIH | None | httpsreporternihgovquickSearchR01HL078782-02 |