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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2009 by Steno Diabetes Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00843388
First Posted: February 13, 2009
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Steno Diabetes Center
  Purpose
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 Intervention Phase
Diabetes Mellitus Nephropathy Blood Pressure Drug: Spironolacton (hexalacton(R)) Drug: placebo tablet Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Steno Diabetes Center:

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

Secondary Outcome Measures:
  • GFR [ Time Frame: 60 days ]
  • ambulatory blood pressure [ Time Frame: 60 days ]
  • plasma renin, angiotensin, aldosteron [ Time Frame: 60 days ]

Estimated Enrollment: 20
Study Start Date: March 2009
Estimated Study Completion Date: March 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
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
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
Investigators
Principal Investigator: stine e nielsen, MD Steno Diabetes Center
  More Information

Responsible Party: Peter Rossing, Steno Diabetes Center, Dep 520
ClinicalTrials.gov Identifier: NCT00843388     History of Changes
Other Study ID Numbers: 2306
Eudra CT: 2008-004839-38
First Submitted: February 12, 2009
First Posted: February 13, 2009
Last Update Posted: October 12, 2017
Last Verified: January 2009

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases