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Clinical Trials/ACTRN12606000128594
ACTRN12606000128594
Not yet recruiting
Not Applicable

Does habitual low dietary sodium intake augment the response to angiotensin receptor blockade and thiazide therapy in hypertensive patients with type 2 diabetes and elevated albumin excretion rate?

Researcher Initiated Study- Professor George Jerums - Endocrine Centre of Excellence, Austin Health & University of Melbourne0 sites32 target enrollmentStarted: April 7, 2006Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Researcher Initiated Study- Professor George Jerums - Endocrine Centre of Excellence, Austin Health & University of Melbourne
Enrollment
32

Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional
Allocation
Randomised controlled trial
Primary Purpose
Treatment
Masking
Blinded (masking used)

Eligibility Criteria

Ages
20 Years to 80 Years (—)
Sex
All

Inclusion Criteria

  • 1\. Type 2 diabetes mellitus.2\. Hypertension (blood pressure \>140/90 or taking antihypertensive therapy).3\. Albumin excretion rate \> 10 µg/min (median of three consecutive measurements).4\. Urinary sodium excretion either \> 200 mmole/24 hr on two out of three consecutive occasions (habitual high dietary sodium intake) or \< 100 mmole/24 hr on two out of three consecutive occasions (habitual low dietary sodium intake). It is proposed to study 16 patients with habitual high dietary sodium intake and 16 patients with habitual low dietary sodium intake matched for BMI. Matching for BMI will be performed because of the documented association between total caloric intake and urinary sodium excretion in the DASH study.185\. Caucasian ethnicity.

Exclusion Criteria

  • 1\. Serum potassium \> 5\.0 mM.2\. Serum creatinine \> 200 µM.3\. Albumin excretion rate \> 200 µg/min.4\. HbA1C \> 10\.0%.5\. Major systemic illness.6\. Drug dependence.7\. Atrial fibrillation.8\. Lactose intolerance (lactose capsules will be used as placebo).

Investigators

Sponsor
Researcher Initiated Study- Professor George Jerums - Endocrine Centre of Excellence, Austin Health & University of Melbourne

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