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

February 12, 2009 updated by: Steno Diabetes Center Copenhagen

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
60 days treatment with tablet hexalacton 25 mg OD.
Drug: Spironolacton (hexalacton(R))
Tablet Spironolacton 25 mg OD
Placebo Comparator: 2
Inactive drug of 25 mg OD
Drug: placebo tablet
placebo tablet 25 mg OD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
albuminuria, expected decrease
Time Frame: 60 days
60 days

Secondary Outcome Measures

Outcome Measure
Time Frame
GFR
Time Frame: 60 days
60 days
ambulatory blood pressure
Time Frame: 60 days
60 days
plasma renin, angiotensin, aldosteron
Time Frame: 60 days
60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Steno Diabetes Center Copenhagen

Investigators

  • Principal Investigator: stine e nielsen, MD, Steno Diabetes Center Copenhagen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Anticipated)

March 1, 2010

Study Completion (Anticipated)

March 1, 2010

Study Registration Dates

First Submitted

February 12, 2009

First Submitted That Met QC Criteria

February 12, 2009

First Posted (Estimate)

February 13, 2009

Study Record Updates

Last Update Posted (Estimate)

February 13, 2009

Last Update Submitted That Met QC Criteria

February 12, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2306
  • Eudra CT: 2008-004839-38

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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