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

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00843388

Enrollment

Registered

2009-02-13

Start date

2009-03-31

Completion date

2010-03-31

Last updated

2009-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Pressure, Diabetes Mellitus, Nephropathy

Brief 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.

Interventions

DRUGSpironolacton (hexalacton(R))

Tablet Spironolacton 25 mg OD

DRUGplacebo tablet

placebo tablet 25 mg OD

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
albuminuria, expected decrease	60 days

Secondary

Measure	Time frame
GFR	60 days
ambulatory blood pressure	60 days
plasma renin, angiotensin, aldosteron	60 days

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026