Hypoglycemia and Autonomic Nervous System Function

Hypoglycemia Clinical Trial

— HypoANS  

Official title:

Hypoglycemia and Autonomic Nervous System Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01816893
• Other study ID #: 2004P001233
• Secondary ID: R01DK063296M01RR
• Status: Completed
• Phase: N/A
• First received: March 20, 2013
• Last updated: March 7, 2018
• Start date: June 8, 2004
• Est. completion date: November 6, 2007

Study information

• Verified date: March 2018
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: November 6, 2007
• Est. primary completion date: November 6, 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypoglycemia

Intervention

Other:
• Hypoglycemic hyperinsulinemic clamp

• Euglycemic hyperinsulinemic clamp

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (5)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	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)

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. — View Citation

Gibbons CH, Adler GK, Bonyhay I, Freeman R. Experimental hypoglycemia is a human model of stress-induced hyperalgesia. Pain. 2012 Nov;153(11):2204-9. doi: 10.1016/j.pain.2012.06.030. Epub 2012 Aug 23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Baroreflex Sensitivity	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.	16 hours after euglycemic and hypoglycemic clamps as compared to baseline
Secondary	Muscle Sympathetic Nerve Activity	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.	16 hours after euglycemic and hypoglycemic clamps
Secondary	Catecholamine Response to Lower-body Negative Pressure	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.	16 hours after euglycemic and hypoglycemic clamps