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

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ClinicalTrials.gov Identifier: NCT00843388
Recruitment Status : Unknown
Verified January 2009 by Steno Diabetes Center Copenhagen.
Recruitment status was:  Not yet recruiting
First Posted : February 13, 2009
Last Update Posted : February 13, 2009
Sponsor:
Information provided by:
Steno Diabetes Center Copenhagen

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Nephropathy Blood Pressure Drug: Spironolacton (hexalacton(R)) Drug: placebo tablet Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Doubleblind Placebo Controlled Crossover Study With Hexalacton in Patients With Type 1 Diabetes and Microalbuminuria
Study Start Date : March 2009
Estimated Primary Completion Date : March 2010
Estimated Study Completion Date : March 2010

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. albuminuria, expected decrease [ Time Frame: 60 days ]

Secondary Outcome Measures :
  1. GFR [ Time Frame: 60 days ]
  2. ambulatory blood pressure [ Time Frame: 60 days ]
  3. plasma renin, angiotensin, aldosteron [ Time Frame: 60 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00843388


Sponsors and Collaborators
Steno Diabetes Center Copenhagen
Investigators
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Principal Investigator: stine e nielsen, MD Steno Diabetes Center Copenhagen
More Information
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Responsible Party: Peter Rossing, Steno Diabetes Center, Dep 520
ClinicalTrials.gov Identifier: NCT00843388    
Other Study ID Numbers: 2306
Eudra CT: 2008-004839-38
First Posted: February 13, 2009    Key Record Dates
Last Update Posted: February 13, 2009
Last Verified: January 2009
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases