We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Hypoglycemia and Autonomic Nervous System Function (HypoANS)

This study is currently recruiting participants.
Verified July 2017 by Gail Adler, Brigham and Women's Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT01816893
First Posted: March 22, 2013
Last Update Posted: July 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Beth Israel Deaconess Medical Center
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Gail Adler, Brigham and Women's Hospital
  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: Spironolactone and hypoglycemia Drug: Placebo and hypoglycemia Drug: Placebo and euglycemia

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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Modified Oxford method assessment of baroreflex function [ Time Frame: 16 hours after euglycemic and hypoglycemic clamps ]
    Baroreflex sensitivity assessed about 16 hours after the euglycemic and hypoglycemic clamps


Secondary Outcome Measures:
  • Muscle sympathetic nerve activity [ Time Frame: 16 hours after euglycemic and hypoglycemic clamps ]
    Muscle sympathetic nerve activity (MSNA) about 16 hours after the euglycemic and hypoglycemic clamps

  • Catecholamine response to lower-body negative pressure [ Time Frame: 16 hours after euglycemic and hypoglycemic clamps ]
    norepinephrine levels assessed during lower body negative pressure about 16 to 20 hours after completion of the euglycemic or hypoglycemic clamp


Other Outcome Measures:
  • Modified Oxford method assessment of baroreflex function [ Time Frame: during euglycemic and hypoglycemic clamps ]
    Baroreflex sensitivity will be assessed at beginning and end of euglycemic and hypoglycemic clamps


Estimated Enrollment: 260
Study Start Date: January 2005
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: June 2018 (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: Spironolactone and hypoglycemia Drug: Placebo and hypoglycemia Drug: Placebo and euglycemia
Active Comparator: hypoglycemic clamp plus placebo
participant undergoes a hypoglycemic hyperinsulinemic clamp with placebo pretreatment
Drug: Spironolactone and hypoglycemia Drug: Placebo and hypoglycemia Drug: Placebo and euglycemia
Experimental: hypoglycemia plus spironolactone
participant undergoes a hypoglycemic hyperinsulinemic clamp with spironolactone pretreatment
Drug: Spironolactone and hypoglycemia Drug: Placebo and hypoglycemia Drug: Placebo and euglycemia

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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 alcoholism.
  • 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, angiotensin converting enzyme (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 glomerular filtration rate (GFR ) < 50 mL/min
  Contacts and Locations
Information from the National Library of Medicine

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): NCT01816893


Contacts
Contact: Rebecca Easly, BA 617-525-7357 reasly@bwh.harvard.edu

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02115
Contact: Jeffery White         
Principal Investigator: Roy Freeman, MD         
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Rebecca Easly, BA       reasly@bwh.harvard.edu   
Principal Investigator: Gail K Adler, MD, PhD         
Sponsors and Collaborators
Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
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
K24HL103845 ( U.S. NIH Grant/Contract )
R01HL109634 ( U.S. NIH Grant/Contract )
First Submitted: March 20, 2013
First Posted: March 22, 2013
Last Update Posted: July 25, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Additional relevant MeSH terms:
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Spironolactone
Hypoglycemic Agents
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents