NCT01089309

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 2004

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

March 7, 2010

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 18, 2010

Completed
Last Updated

March 29, 2010

Status Verified

March 1, 2010

Enrollment Period

3.1 years

First QC Date

March 7, 2010

Last Update Submit

March 26, 2010

Conditions

Arterial StiffnessArterial Elasticity

Keywords

Aldosterone BlockadeArterial elasticityGlycemic control

Study Arms (1)

Aldosteron blokade, Arterial stiffness, Glucose homeostasis

EXPERIMENTAL
Drug: Spironolactone

Interventions

SpironolactoneDRUG

Spironolactone orally, at a dose of 50 mg/day for 12 months

Aldosteron blokade, Arterial stiffness, Glucose homeostasis

Eligibility Criteria

Age45 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. patients with type 2 diabetes mellitus

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wolfson Medical Center

Holon, 58100, Israel

Location

MeSH Terms

Interventions

Spironolactone

Intervention Hierarchy (Ancestors)

LactonesOrganic ChemicalsPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

March 7, 2010

First Posted

March 18, 2010

Study Start

May 1, 2004

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

March 29, 2010

Record last verified: 2010-03

Locations

IL(1)