Hypoglycemia and the Mineralocorticoid Receptor (HypoMR)
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
|Official Title:||Hypoglycemia and the Mineralocorticoid Receptor|
- Change from Baseline in Cardiovascular Autonomic Function [ Time Frame: Baseline and 2 hours after hypoglycemia ] [ Designated as safety issue: No ]
- Change from Baseline in Inflammation [ Time Frame: Baseline and 2 hours after hypoglycemia ] [ Designated as safety issue: No ]
- Change from Baseline in fMRI [ Time Frame: Baseline and after exposure to hypoglycemia ] [ Designated as safety issue: No ]
|Study Start Date:||January 2011|
|Estimated Study Completion Date:||August 2016|
|Estimated Primary Completion Date:||August 2016 (Final data collection date for primary outcome measure)|
hypoglycemia (50 mg/dl) with pretreatment with two doses of eplerenone (100 mg of eplerenone per dose)
100mg x 2
Placebo Comparator: placebo
hypoglycemia of 50 mg/dl plus placebo
The effect of ongoing hypoglycemia on cardiovascular autonomic function is unclear and the focus of this protocol. In our preliminary studies, the investigators demonstrated that baroreflex sensitivity is impaired during hypoglycemia in healthy individuals. Treatment with eplerenone (200mg total administered in two doses in the 15 hours prior to the hypoglycemic clamp) prevented this impairment.
The study is based on the overarching hypothesis that hypoglycemia leads to increases in aldosterone/mineralocorticoid receptor (MR) activity and increased cardiovascular injury.
This study will address the following Specific Aims:
To test the hypothesis that MR blockade will reduce the adverse effects of hypoglycemia on inflammation and on autonomic control of cardiovascular function.
The investigators will determine the effects of hypoglycemia (50 mg/dl for 2.0 hours) on the blood inflammatory factor interleukin-6 levels, on cardiovascular autonomic function (baroreflex sensitivity and heart rate variability) and on arrhythmia risk (microvolt T-wave alternans (MTWA)) in each subject under two conditions - pretreatment with MR blockade (eplerenone) and pretreatment with placebo.
To investigate the role of hypoglycemia on fMRI.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01394627
|Contact: Ajaykumar D Rao, MDfirstname.lastname@example.org|
|United States, Massachusetts|
|Brigham and Women's Hospital||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator: Gail K Adler, MD, PhD|
|Study Chair:||Ajaykumar D Rao, MD||Brigham and Women's Hospital|
|Principal Investigator:||Gail K Adler, MD, PhD||Brigham and Women's Hospital|