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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Steno Diabetes Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Steno Diabetes Center
ClinicalTrials.gov Identifier:
NCT00843388
First received: February 12, 2009
Last updated: NA
Last verified: January 2009
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • GFR [ Time Frame: 60 days ] [ Designated as safety issue: No ]
  • ambulatory blood pressure [ Time Frame: 60 days ] [ Designated as safety issue: No ]
  • plasma renin, angiotensin, aldosteron [ Time Frame: 60 days ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00843388

Sponsors and Collaborators
Steno Diabetes Center
Investigators
Principal Investigator: stine e nielsen, MD Steno Diabetes Center
  More Information

No publications provided

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
Study First Received: February 12, 2009
Last Updated: February 12, 2009
Health Authority: Denmark: Danish Medicines Agency
Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

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

ClinicalTrials.gov processed this record on October 23, 2014