Hypoglycemia and Autonomic Nervous System Function
HypoANS
3 other identifiers
interventional
22
1 country
2
Brief Summary
The goals of this proposal are to determine the effects of hypoglycemia on the autonomic nervous system.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2004
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 8, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 6, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
November 6, 2007
CompletedFirst Submitted
Initial submission to the registry
March 20, 2013
CompletedFirst Posted
Study publicly available on registry
March 22, 2013
CompletedResults Posted
Study results publicly available
March 6, 2018
CompletedApril 2, 2018
March 1, 2018
3.4 years
March 20, 2013
January 30, 2018
March 7, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Muscle Sympathetic Nerve Activity
16 hours after euglycemic and hypoglycemic clamps
Catecholamine Response to Lower-body Negative Pressure
16 hours after euglycemic and hypoglycemic clamps
Study Arms (2)
Euglycemic hyperinsulinemic clamp
SHAM COMPARATORparticipant undergoes a euglycemic hyperinsulinemic clamp
Hypoglycemic hyperinsulinemic clamp
ACTIVE COMPARATORparticipant undergoes a hypoglycemic hyperinsulinemic clamp
Interventions
Eligibility Criteria
You may qualify if:
- Healthy volunteers
- Males and females age 18 to 50 years
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Related Publications (4)
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.
PMID: 18332163RESULTAdler 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.
PMID: 19056608RESULTGibbons 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.
PMID: 22921261RESULTAdler 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.
PMID: 20950382RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Gail Kurr Adler
- Organization
- Brigham and Women's Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Gail K Adler, MD, PhD
Brigham and Women's Hospital
- PRINCIPAL INVESTIGATOR
Roy L Freeman, MD
Beth Israel Deaconess Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Medicine
Study Record Dates
First Submitted
March 20, 2013
First Posted
March 22, 2013
Study Start
June 8, 2004
Primary Completion
November 6, 2007
Study Completion
November 6, 2007
Last Updated
April 2, 2018
Results First Posted
March 6, 2018
Record last verified: 2018-03
Data Sharing
- IPD Sharing
- Will not share
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.