Hypoglycemia and Autonomic Nervous System Function

• Status: Unknown status
• Trial end date: 0000-00-00
• Target enrollment: 260
• Participant gender: Both

Summary

The goals of this proposal are to determine the effects of hypoglycemia on the autonomic nervous system and whether administration of a mineralocorticoid receptor antagonist modifies the effects of hypoglycemia on the autonomic nervous system

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Brigham and Women's Hospital
• Collaborator: Beth Israel Deaconess Medical Center
• Treatments: Eplerenone; Hypoglycemic Agents
• Last Updated: 2013-03-20

Criteria

Inclusion Criteria:

• Healthy volunteers

• Males and females age 18 to 50

• Type I Diabetes Mellitus, OR:

• Type II Diabetes Mellitus controlled by diet, exercise and oral glycemic control agents (metformin, thiazolidinediones, sulfonylureas)

Exclusion Criteria:

• Hemoglobin A1c > 9% (Type 2 Diabetes mellitus)

• Hemoglobin A1c < 8% or > 10% (Type 1 Diabetes mellitus)

• Pregnancy

• Lactation

• Recurrent hypoglycemic episodes within the past month

• Subjects who smoke will be required to refrain from smoking for the duration of each study admission

• Clinically significant coronary artery, cerebrovascular, or peripheral vascular disease, or presence of systemic illness that might affect autonomic function. Such illnesses include diabetes mellitus (controls only) congestive heart failure, hypertension (controls only), renal, pulmonary, hepatic disease, anemia, malignancies, untreated thyroid disease, and alchoholism.

• Current major depressive illness

• In both controls and diabetic subjects, any individuals on oral, injected, inhaled or topical corticosteroids within the last year or oral contraceptives within the past 3 months will be excluded.

• Use of medications other than thyroxine in control subjects

• Use of medications other than thyroxine, metformin, thiazolidinediones, sulfonylureas, statins, ACE inhibitors, angiotensin receptor blockers (ARBs), and hydrochlorothiazide (HCTZ) in diabetic subjects

• Blood pressure > 140/90 mmHg.

• Creatinine > 1.5 mg/dL

• Serum potassium >5.2 mmol/L

• Estimated GFR < 50 mL/min