Clinical trial NCT01816893: Hypoglycemia and Autonomic Nervous System Function
Official title: Hypoglycemia and Autonomic Nervous System Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypoglycemia
Keywords: Hypoglycemia
Autonomic Nervous System
baroreflex sensitivity
muscle sympathetic nerve activity
lower body negative pressure
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Beth Israel Deaconess Medical Center
name: National Institutes of Health (NIH)
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: National Center for Research Resources (NCRR)
First posted: 2013-03-22
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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


Eligibility 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

Primary outcomes:
measure: Change in Baroreflex Sensitivity
timeFrame: 16 hours after euglycemic and hypoglycemic clamps as compared to baseline
Secondary outcomes:
measure: Muscle Sympathetic Nerve Activity
timeFrame: 16 hours after euglycemic and hypoglycemic clamps
measure: Catecholamine Response to Lower-body Negative Pressure
timeFrame: 16 hours after euglycemic and hypoglycemic clamps
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Gail K Adler, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beth Israel Deaconess Medical Center
name: Roy L Freeman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dotson S, Freeman R, Failing HJ, Adler GK. Hypoglycemia increases serum interleukin-6 levels in healthy men and women. Diabetes Care. 2008 Jun;31(6):1222-3. doi: 10.2337/dc07-2243. Epub 2008 Mar 10.
citation: Adler GK, Bonyhay I, Failing H, Waring E, Dotson S, Freeman R. Antecedent hypoglycemia impairs autonomic cardiovascular function: implications for rigorous glycemic control. Diabetes. 2009 Feb;58(2):360-6. doi: 10.2337/db08-1153. Epub 2008 Dec 3.
citation: Gibbons CH, Adler GK, Bonyhay I, Freeman R. Experimental hypoglycemia is a human model of stress-induced hyperalgesia. Pain. 2012 Nov;153(11):2204-2209. doi: 10.1016/j.pain.2012.06.030. Epub 2012 Aug 23.
citation: Adler GK, Bonyhay I, Curren V, Waring E, Freeman R. Hypoglycaemia increases aldosterone in a dose-dependent fashion. Diabet Med. 2010 Nov;27(11):1250-5. doi: 10.1111/j.1464-5491.2010.03087.x.