Clinical Trials Logo

Clinical Trial Summary

The purpose of this study is to look at whether blockade of the mineralocorticoid receptor will result in changes in the cardiovascular and inflammatory response to hypoglycemia.


Clinical Trial Description

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 Design


Related Conditions & MeSH terms


NCT number NCT01394627
Study type Interventional
Source Brigham and Women's Hospital
Contact
Status Completed
Phase N/A
Start date January 2011
Completion date August 2016

See also
  Status Clinical Trial Phase
Completed NCT03482154 - Malglycemia in the Pediatric Hematopoietic Stem Cell Transplant Population
Completed NCT03667053 - Trial to Confirm the Efficacy and Safety of Dasiglucagon in the Treatment of Hypoglycemia in T1DM Children Phase 3
Active, not recruiting NCT03422471 - Hypoglycemia and Autonomic Nervous System Function- B2 N/A
Recruiting NCT05379686 - Low-Dose Glucagon and Advanced Hybrid Closed-Loop System for Prevention of Exercise-Induced Hypoglycaemia in People With Type 1 Diabetes N/A
Completed NCT05597605 - The SHINE Study: Safety of Implant and Preliminary Performance of the SHINE SYSTEM in Diabetic Subjects N/A
Not yet recruiting NCT05990933 - Role of Adrenaline in in the Inflammatory Response in Diabetes N/A
Withdrawn NCT03736083 - Introducing CGM at Type 1 Diabetes Diagnosis N/A
Not yet recruiting NCT02909881 - Dose Response Oxidation of a Sweet-corn Derived Sugar (PhytoSpherix) During Exercise in Endurance Trained Athletes N/A
Completed NCT02966275 - Post Bariatric Closed Loop Glucagon Trial N/A
Withdrawn NCT02518022 - How to be Safe With Alcoholic Drinks in Diabetes N/A
Completed NCT02213003 - Allogeneic Islet Cells Transplanted Onto the Omentum Phase 1/Phase 2
Completed NCT01176656 - Hypoglycemia: Physician and Patient Perspectives N/A
Completed NCT01147276 - Vildagliptin and the Glucagon Response to Hypoglycemia in Type 1 Diabetes Phase 4
Completed NCT00998374 - Comparison Between Pyloric Preserving and Non-Pyloric Preserving Bariatric Surgery With Glucose Challenge N/A
Terminated NCT01225159 - Tight Glycaemic Control During Cardiac Surgery N/A
Completed NCT00373854 - Study of How Low Blood Sugar Affects the Way Blood Vessels Work N/A
Completed NCT00285233 - Delayed Mycophenolate Mofetil in Single-Donor Islet Allotransplantation in Type 1 Diabetes Phase 1/Phase 2
Recruiting NCT05916131 - Pilot Feasibility Study for HypoPals, a Mobile Health Program for Improving Hypoglycemia Management. N/A
Terminated NCT04026750 - Insulin Tolerance Test Study in Patients With Type 1 Diabetes Phase 1
Completed NCT05133765 - The SMART B Exercise Study :''The SMART Study'' N/A