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

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ClinicalTrials.gov Identifier: NCT00335413
Recruitment Status : Completed
First Posted : June 9, 2006
Last Update Posted : June 5, 2008
Sponsor:
Information provided by:
Steno Diabetes Center Copenhagen

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

Condition or disease Intervention/treatment Phase
Hypertension Drug: Spironolactone Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Autoregulation of Glomerular Filtration Rate in Patients With Type 1 Diabetes During Spironolactone Therapy
Study Start Date : June 2006
Actual Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1




Primary Outcome Measures :
  1. Changes in glomerular filtration rate

Secondary Outcome Measures :
  1. Changes in blood pressure
  2. Changes in albuminuria
  3. Changes in fractional albumin clearance


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT00335413


Sponsors and Collaborators
Steno Diabetes Center Copenhagen
Investigators
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Principal Investigator: Hans-Henrik Parving, MD,DMSc,Prof Steno Diabetes Center Copenhagen

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ClinicalTrials.gov Identifier: NCT00335413     History of Changes
Other Study ID Numbers: 2006-001453-10
2612-3144
KA-20060055
First Posted: June 9, 2006    Key Record Dates
Last Update Posted: June 5, 2008
Last Verified: June 2008

Keywords provided by Steno Diabetes Center Copenhagen:
Renal autoregulation
Glomerular filtration rate
Type 1 diabetes

Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Spironolactone
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents