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Hypoglycemia and Autonomic Nervous System Function (HypoANS)

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ClinicalTrials.gov Identifier: NCT01816893
Recruitment Status : Completed
First Posted : March 22, 2013
Results First Posted : March 6, 2018
Last Update Posted : April 2, 2018
Sponsor:
Collaborators:
Beth Israel Deaconess Medical Center
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
Gail Adler, Brigham and Women's Hospital

Brief Summary:
The goals of this proposal are to determine the effects of hypoglycemia on the autonomic nervous system.

Condition or disease Intervention/treatment Phase
Hypoglycemia Other: Hypoglycemic hyperinsulinemic clamp Other: Euglycemic hyperinsulinemic clamp Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Hypoglycemia and Autonomic Nervous System Function
Actual Study Start Date : June 8, 2004
Actual Primary Completion Date : November 6, 2007
Actual Study Completion Date : November 6, 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypoglycemia

Arm Intervention/treatment
Sham Comparator: Euglycemic hyperinsulinemic clamp
participant undergoes a euglycemic hyperinsulinemic clamp
Other: Euglycemic hyperinsulinemic clamp
Active Comparator: Hypoglycemic hyperinsulinemic clamp
participant undergoes a hypoglycemic hyperinsulinemic clamp
Other: Hypoglycemic hyperinsulinemic clamp



Primary Outcome Measures :
  1. Change in Baroreflex Sensitivity [ Time Frame: 16 hours after euglycemic and hypoglycemic clamps as compared to baseline ]
    The change in baroreflex sensitivity (milliseconds/mm Hg) is calculated as baroreflex sensitivity (milliseconds/mm Hg) on day 3 [assessed 16 hours after the clamp] minus baroreflex sensitivity (milliseconds/mm Hg) on day 1 [baseline assessment on the day prior to the clamp]). Change in baroreflex sensitivity in euglycemic clamp arm is compared to change in baroreflex sensitivity in hypoglycemic arm.


Secondary Outcome Measures :
  1. Muscle Sympathetic Nerve Activity [ Time Frame: 16 hours after euglycemic and hypoglycemic clamps ]
    Muscle sympathetic nerve activity (MSNA), at rest and immediately after nitroprusside, was measured on Day 3 about 16 hours after the euglycemic and hypoglycemic clamps.

  2. Catecholamine Response to Lower-body Negative Pressure [ Time Frame: 16 hours after euglycemic and hypoglycemic clamps ]
    Plasma norepinephrine response to lower body negative pressure (at the minus 40 mm Hg data point) on Day 3 about 16 to 20 hours after completion of the euglycemic or hypoglycemic clamp.



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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 years

Exclusion Criteria

  • Pregnancy
  • Lactation
  • Subjects who smoke or are on other forms of nicotine will be excluded
  • Clinically evident coronary artery, cerebrovascular, or peripheral vascular disease, or presence of systemic illness that might affect autonomic function. Such illnesses include diabetes mellitus, congestive heart failure, hypertension, renal, pulmonary, hepatic disease, anemia, malignancies, untreated thyroid disease, and alcoholism.
  • Current major depressive illness
  • 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

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


Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Center for Research Resources (NCRR)
Investigators
Principal Investigator: Gail K Adler, MD, PhD Brigham and Women's Hospital
Principal Investigator: Roy L Freeman, MD Beth Israel Deaconess Medical Center

Publications of Results:
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
R01DK063296 ( U.S. NIH Grant/Contract )
M01RR002635 ( U.S. NIH Grant/Contract )
First Posted: March 22, 2013    Key Record Dates
Results First Posted: March 6, 2018
Last Update Posted: April 2, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The data collected will comply with the NIH requirements for timely release and data sharing. Data will be shared in the form of publications and presentations in scientific forums. As the NIH has noted, the investigators reserve the right to keep the data restricted in order to perform the initial analyses for this grant proposal and will continue to use the data for further, but not prolonged, exclusive use. Of note, the sharing of this data will be limited by at least the following issues, some unique to this proposal and some not unique. Some of the data obtained in this study is defined to be sensitive in nature, which may restrict its ability to be shared. Data may only be shared with the approval of our IRB and is limited by HIPPA and any other regulations that may be promulgated during the course of this proposal.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Gail Adler, Brigham and Women's Hospital:
Hypoglycemia
Autonomic Nervous System
baroreflex sensitivity
muscle sympathetic nerve activity
lower body negative pressure

Additional relevant MeSH terms:
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Hypoglycemic Agents
Physiological Effects of Drugs