Aldosterone and the Metabolic Syndrome: Renin Inhibition Versus Mineralocorticoid Receptor (MR) Antagonism

NCT01103245 Phase 1 COMPLETED Results posted

The purpose of this study is to determine the effects of mineralocorticoid receptor (MR) antagonism and renin inhibition on glucose metabolism in humans.

Details

Lead sponsor	Vanderbilt University Medical Center
Phase	Phase 1
Status	COMPLETED
Enrolment	69
Start date	2010-03
Completion	2013-09

Conditions

• Metabolic Diseases
• Diabetes Mellitus
• Endocrine System Diseases
• Glucose Metabolism Disorders

Interventions

• Hydrochlorothiazide (HCTZ)
• Aliskiren 150 mg (ALI 150)
• Spironolactone (SPL 25)
• Aliskiren 300 mg (ALI 300)
• Spironolactone 50 mg (SPL 50)

Primary outcomes

• Plasma Insulin — at the end of each 1 month study period ( 3 times in total)
  A Hyperglycemic clamp was performed once during each study period to assess glucose stimulated insulin secretion. Glucose is infused intravenously to maintain blood glucose near 200 mg/dL to stimulate insulin secretion. During this time plasma insulin levels were measured and the insulin response is reported as the incremental increase over the first 10 minutes of glucose administration.
• Plasma Glucose — at the end of each 1 month study period ( 3 times in total)
  Fasting plasma glucose, measured during hyperglycemic clamp

Countries

United States