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NCT00843388 Clinical Trial

A Crossover Study With Hexalacton in Patients With Type 1 Diabetes and Microalbuminuria

Diabetes Mellitus Clinical Trial

Official title:
A Randomized Doubleblind Placebo Controlled Crossover Study With Hexalacton in Patients With Type 1 Diabetes and Microalbuminuria

Clinical Trial Details — Status: Unknown status

Administrative data
NCT number NCT00843388
Other study ID # 2306
Secondary ID Eudra CT: 2008-0
Status Unknown status
Phase Phase 4
First received February 12, 2009
Last updated February 12, 2009
Start date March 2009
Est. completion date March 2010

Study information
Verified date January 2009
Source Steno Diabetes Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A double blind, randomized, cross over study in type 1 diabetic patients. 20 patients, age 18-65 years is treated with spironolacton (Hexalacton (R)) for 60 days followed by 60 days treatment with placebo(or opposite). Primary aim: albuminuria, an expected decrease during hexalacton treatment. Secondary aim: ambulatory blood pressure, GFR, plasma-renin, angiotensin, aldosteron.

Recruitment information / eligibility
Status Unknown status
Enrollment 20
Est. completion date March 2010
Est. primary completion date March 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- type 1 diabetes

- age 18-80 years

- microalbuminuria

Exclusion Criteria:

- blood pressure> 160/100 mmHg

- persistent macroalbuminuria

- pregnancy or in risc of this

- P-Potassium>5.7 mmol/l

- Eplerone treatment

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Spironolacton (hexalacton(R))
Tablet Spironolacton 25 mg OD
• placebo tablet
placebo tablet 25 mg OD

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Steno Diabetes Center

Outcome
Type Measure Description Time frame Safety issue
Primary albuminuria, expected decrease 60 days
Secondary GFR 60 days
Secondary ambulatory blood pressure 60 days
Secondary plasma renin, angiotensin, aldosteron 60 days
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