Effect of Aldosterone Blockade on Arterial Compliance | NCT01089309

Studies
Effect of Aldosterone Blockade on Arterial Compliance

NCT01089309

Sponsor

Wolfson Medical Center

Status

Completed

Last Update Posted

Mar 29, 2010Estimated

Enrollment

51Actual

Phase

Phase 4

Conditions

Arterial Stiffness
Arterial Elasticity

Interventions

Spironolactone

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2004

Primary Completion Date

Jun 2007Actual

Completion Date

Jun 2007Actual

First Submitted Date

Mar 7, 2010

First Submission Date that Met QC Criteria

Mar 17, 2010

First Posted Date

Mar 18, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 26, 2010

Last Update Posted Date

Mar 29, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The present study investigated the long-term (12 months) effect of spironolactone treatment on glucose homeostasis, metabolic parameters and vascular properties.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

51Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Aldosteron blokade, Arterial stiffness, Glucose homeostasis	Experimental		Drug: Spironolactone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Spironolactone	Drug	Spironolactone orally, at a dose of 50 mg/day for 12 months	Aldosteron blokade, Arterial stiffness, Glucose homeostasis

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

1. patients with type 2 diabetes mellitus

Exclusion Criteria:

history of unstable angina, myocardial infarction (MI), cerebrovascular accident (CVA)
major surgery within the six months preceding entrance to the study
unbalanced endocrine disease
any disease that might affect absorption of medications
plasma creatinine >2.5 mg/dl
elevation of liver enzymes to more that twice the upper normal limit
plasma potassium levels >5.5 mg/dl

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Wolfson Medical Center		Holon		58100	Israel

Intervention Browse Module

MeSH Terms

ID	Term
D013148	Spironolactone

Ancestor Terms

ID	Term
D007783	Lactones
D009930	Organic Chemicals
D011283	Pregnenes
D011278	Pregnanes
D013256

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Browse Branches

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