NCT00335413

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_4 hypertension

Timeline
Completed

Started Jun 2006

Shorter than P25 for phase_4 hypertension

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

June 7, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 9, 2006

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

June 5, 2008

Status Verified

June 1, 2008

First QC Date

June 7, 2006

Last Update Submit

June 4, 2008

Conditions

Hypertension

Keywords

Renal autoregulationGlomerular filtration rateType 1 diabetes

Outcome Measures

Primary Outcomes (1)

  • Changes in glomerular filtration rate

Secondary Outcomes (3)

  • Changes in blood pressure

  • Changes in albuminuria

  • Changes in fractional albumin clearance

Interventions

SpironolactoneDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Chung EY, Ruospo M, Natale P, Bolignano D, Navaneethan SD, Palmer SC, Strippoli GF. Aldosterone antagonists in addition to renin angiotensin system antagonists for preventing the progression of chronic kidney disease. Cochrane Database Syst Rev. 2020 Oct 27;10(10):CD007004. doi: 10.1002/14651858.CD007004.pub4.

    PMID: 33107592DERIVED

MeSH Terms

Conditions

HypertensionDiabetes Mellitus, Type 1

Interventions

Spironolactone

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

LactonesOrganic ChemicalsPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Hans-Henrik Parving, MD,DMSc,Prof

    Steno Diabetes Center Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 7, 2006

First Posted

June 9, 2006

Study Start

June 1, 2006

Study Completion

April 1, 2007

Last Updated

June 5, 2008

Record last verified: 2008-06