Autoregulation of Glomerular Filtration Rate in Patients With Type 1 Diabetes During Spironolactone Therapy - Tabular View

Tracking Information

First Received Date ^ICMJE

June 7, 2006

Last Updated Date

June 4, 2008

Start Date ^ICMJE

June 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Changes in glomerular filtration rate

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00335413 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Changes in blood pressure
Changes in albuminuria
Changes in fractional albumin clearance

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Autoregulation of Glomerular Filtration Rate in Patients With Type 1 Diabetes During Spironolactone Therapy

Official Title ^ICMJE

Autoregulation of Glomerular Filtration Rate in Patients With Type 1 Diabetes During Spironolactone Therapy

Brief Summary

To evaluate the impact of spironolactone treatment on renal autoregulation in hypertensive type 1 diabetic patients.

Detailed Description

Double-masked, randomized, crossover trial. In random order, patients will be treated with spironolactone 25 mg o.d. and matched placebo for 28 days.

On the last day of treatment, GFR will be determined twice on the same day: first without clonidine and secondly after injection of clonidine (clonidine induces a transient reduction in blood pressure, with no influence on renal plasma flow and GFR), in order to evaluate the effect of antihypertensive treatment with spironolactone on renal autoregulation of GFR.

The study will be preceded by a wash-out period of 1 month for patients receiving antihypertensive medication. Patients will be instructed to measure blood pressure twice daily, three days a week during this period. If, during the washout period, blood pressure exceeds 170/105 mm Hg or persistent edemas develop, treatment with long-acting loop diuretics will be initiated and continued throughout the rest of the study. If blood pressure despite diuretic treatment still exceeds 170 mm Hg systolic and/or 105 mm Hg diastolic, the patient will be excluded from the study and previous/appropriate antihypertensive treatment will be restarted.

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study

Condition ^ICMJE

Hypertension

Intervention ^ICMJE

Drug: Spironolactone

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

April 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Type 1 diabetes
Age between 18 and 70 years
Blood pressure ≥ 135 mm Hg systolic and/or ≥ 85 mm Hg diastolic or ongoing antihypertensive treatment
Informed consent

Exclusion Criteria:

Diabetic nephropathy
Other known kidney or renal tract disease
Malignant hypertension
Blood pressure > 170/105 at baseline or during AHT wash-out period
Plasma potassium > 4.7 mmol/l
Elevated plasma creatinine (>88 µmol/l for women and >100 µmol/l for men)
Symptoms of Ischemic heart disease within 3 months prior to study start
Previous cerebrovascular event (apoplexy, TCI)
Abuse of medicine or alcohol
Pregnancy or breastfeeding
Woman of child-bearing age who are not using adequate contraception
ASA treatment > 1g/day or regular use of NSAIDs
Known allergy to or side-effects of spironolactone
Inability to understand patient information

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00335413

Responsible Party

Study ID Numbers ^ICMJE

2006-001453-10, 2612-3144, KA-20060055

Study Sponsor ^ICMJE

Steno Diabetes Center

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Hans-Henrik Parving, MD,DMSc,Prof

Steno Diabetes Center

Information Provided By

Steno Diabetes Center

Verification Date

June 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP