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Completed

NCT Number: NCT01816893

Hypoglycemia and Autonomic Nervous System Function

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

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Key information

Conditions

Hypoglycemia Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hypoglycemic Hyperinsulinemic Clamp

Other

Euglycemic Hyperinsulinemic Clamp

Other

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • Beth Israel Deaconess Medical Center
  • National Center for Research Resources (NCRR)
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • National Institutes of Health (NIH)

Registry information

Acronym: HypoANS

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Mar 22, 2013
Registry last updated
Apr 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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