Trial record 3 of 108 for:    Open Studies | "Hypoglycemia"

Hypoglycemia and Autonomic Nervous System Function (HypoANS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Brigham and Women's Hospital
Sponsor:
Collaborator:
Beth Israel Deaconess Medical Center
Information provided by (Responsible Party):
Gail Adler, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01816893
First received: March 20, 2013
Last updated: NA
Last verified: March 2013
History: No changes posted
  Purpose

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


Condition Intervention
Hypoglycemia
Drug: Eplerenone
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Hypoglycemia and Autonomic Nervous System Function

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Modified Oxford method assessment of baroreflex function [ Time Frame: 1 day after euglycemic and hypoglycemic clamps ] [ Designated as safety issue: No ]
  • Muscle sympathetic nerve activity [ Time Frame: 1 day after euglycemic and hypoglycemic clamps ] [ Designated as safety issue: No ]
  • Catecholamine response to lower-body negative pressure [ Time Frame: 1 day after euglycemic and hypoglycemic clamps ] [ Designated as safety issue: No ]
  • Modified Oxford method assessment of baroreflex function [ Time Frame: during euglycemic and hypoglycemic clamps ] [ Designated as safety issue: No ]

Estimated Enrollment: 260
Study Start Date: January 2005
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Euglycemic clamp plus placebo.
participant undergoes a euglycemic hyperinsulinemic clamp with placebo pretreatment
Drug: Placebo
Active Comparator: hypoglycemic clamp plus placebo
participant undergoes a hypoglycemic hyperinsulinemic clamp with placebo pretreatment
Drug: Placebo
Experimental: hypoglycemia plus eplerenone
participant undergoes a hypoglycemic hyperinsulinemic clamp with eplerenone pretreatment
Drug: Eplerenone

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01816893

Contacts
Contact: Maria Baimas-George, BA 617-525-7357 mbaimas-george@partners.org
Contact: Sarah Ballatori, BA 617-632-0648 sballato@bidmc.harvard.edu

Locations
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Maria Baimas-George         
Principal Investigator: Gail K Adler, MD, PhD         
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02115
Contact: Sarah Ballatori         
Principal Investigator: Roy Freeman, MD         
Sponsors and Collaborators
Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
Investigators
Principal Investigator: Gail K Adler, MD, PhD Brigham and Women's Hospital
Principal Investigator: Roy L Freeman, MD Beth Israel Deaconess Medical Center
  More Information

Publications:
Responsible Party: Gail Adler, Associate Professor of Medicine, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01816893     History of Changes
Other Study ID Numbers: 2004P001233
Study First Received: March 20, 2013
Last Updated: March 20, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:
Hypoglycemia
Autonomic Nervous System

Additional relevant MeSH terms:
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Eplerenone
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 16, 2014