This study investigated the effects of LCZ696 on insulin sensitivity, lipolysis, and oxidative metabolism in obese hypertensive subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
QUADRUPLE
Enrollment
98
LCZ696 was provided as 400 mg tablets.
amlodipine was provided as 5 mg tablets.
Matching placebo to LCZ696 and amlodipine.
Novartis Investigative Site
Hanover, Germany
Novartis Investigative Site
Neuss, Germany
Novartis Investigative Site
Maastricht, Netherlands
Change From Baseline in Insulin Sensitivity Index
The insulin sensitivity index was assessed by hyperinsulinemic euglycemic clamp (HEGC). A positive change from baseline indicates improvement.
Time frame: baseline, 8 weeks
Local Adipose Tissue Lipolysis, Glycerol Concentrations
Lipolysis was assessed through subcutaneous adipose tissue microdialysis. The actual measure type is adjusted geometric mean.
Time frame: 57 days
Oxidative Metabolism
Oxidative metabolism was assessed by indirect calorimetry.
Time frame: 57 days
Number of Participants With Adverse Events, Serious Adverse Events and Deaths
Adverse event monitoring was conducted throughout the study.
Time frame: 8 weeks
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