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

Steno Diabetes Center Copenhagen20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Diabetes Mellitus Nephropathy Blood Pressure

Interventions

Spironolacton (hexalacton(R))DRUG

Tablet Spironolacton 25 mg OD

placebo tabletDRUG

placebo tablet 25 mg OD

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

albuminuria, expected decrease

Time frame: 60 days

Secondary Outcomes

GFR

Time frame: 60 days

ambulatory blood pressure

Time frame: 60 days

plasma renin, angiotensin, aldosteron

Time frame: 60 days

Data from ClinicalTrials.gov

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