Salt & Hypertension & Diabetes

• Conditions: Type 2 Diabetes; Hypertension; Microalbuminuria; Metabolic and Endocrine - Diabetes; Cardiovascular - Hypertension

• Registration Number: ACTRN12606000128594
• Lead Sponsor: Researcher Initiated Study- Professor George Jerums - Endocrine Centre of Excellence, Austin Health & University of Melbourne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-04-07
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 32

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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Change in ambulatory blood pressure[From 0 to 4, 8 and from 14 to 18, 22 weeks];2. Change in albumin excretion rate[From 0 to 4, 8, and from 14 to 18, 22 weeks]

Secondary Outcome Measures

Name	Time	Method
1. Acute response of effective renal plasma flow (ERPF) to captopril.[ At baseline.];2. Acute response of renal resistance index (RI) to captopril. [At baseline.];3. Fasting plasma glucose at the time of ERPF and RI measurements.[];4. BMI.[];5. 24 h urinary sodium, potassium and creatinine excretion.[At 0, 4, 8, 14, 18, 22 weeks.];6. Plasma urea, creatinine and electrolytes, renin activity and aldosterone and fasting glucose and C-peptide.[At 0, 4, 8, 14, 18, and 22 weeks.];7. Haemoglobin A1C.[]