Hypoglycemia and the Mineralocorticoid Receptor (HypoMR)
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|ClinicalTrials.gov Identifier: NCT01394627|
Recruitment Status : Completed
First Posted : July 14, 2011
Results First Posted : November 17, 2017
Last Update Posted : November 17, 2017
|Condition or disease||Intervention/treatment||Phase|
|Hypoglycemia||Drug: Eplerenone Drug: Placebo||Not Applicable|
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, and on cardiovascular autonomic function (baroreflex sensitivity) in each subject under two conditions - pretreatment with MR blockade (eplerenone) and pretreatment with placebo.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Basic Science|
|Official Title:||Hypoglycemia and the Mineralocorticoid Receptor|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||August 2016|
|Actual Study Completion Date :||August 2016|
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
- Change From Baseline in Cardiovascular Autonomic Function [ Time Frame: Baseline and 2 hours after hypoglycemia ]Modified oxford procedures was performed in duplicate immediately prior to start of the hypoglycemic clamp and during the last 30 min of the clamp (i.e. during the last 30 min of exposure to 2 hours of hypoglycemia).. We calculated the baroreflex sensitivity (the relationship between RR interval and change in systolic blood pressure defined as the change in the inter-beat cardiac interval in milliseconds per unit change in blood pressure in mmHg) at each time point and then the change in baroreflex sensitivity (BRS during hypoglycemia minus BRS at baseline)
- Change From Baseline in Inflammation [ Time Frame: Baseline and 2 hours after hypoglycemia ]Change in interleukin-6
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01394627
|United States, Massachusetts|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Gail K Adler, MD||Brigham and Women's Hospital|
|Principal Investigator:||Gail K Adler, MD, PhD||Brigham and Women's Hospital|