Back to resultsHypoglycemia and Autonomic Nervous System Function (HypoANS)
Primary Purpose
Hypoglycemia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hypoglycemic hyperinsulinemic clamp
Euglycemic hyperinsulinemic clamp
Sponsored by
About this trial
This is an interventional basic science trial for Hypoglycemia focused on measuring Hypoglycemia, Autonomic Nervous System, baroreflex sensitivity, muscle sympathetic nerve activity, lower body negative pressure
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
Sites / Locations
- Beth Israel Deaconess Medical Center
- Brigham and Women's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Active Comparator
Arm Label
Euglycemic hyperinsulinemic clamp
Hypoglycemic hyperinsulinemic clamp
Arm Description
participant undergoes a euglycemic hyperinsulinemic clamp
participant undergoes a hypoglycemic hyperinsulinemic clamp
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT01816893
First Posted
March 20, 2013
Last Updated
March 7, 2018
Sponsor
Brigham and Women's Hospital
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)
1. Study Identification
Unique Protocol Identification Number
NCT01816893
Brief Title
Hypoglycemia and Autonomic Nervous System Function
Acronym
HypoANS
Official Title
Hypoglycemia and Autonomic Nervous System Function
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
June 8, 2004 (Actual)
Primary Completion Date
November 6, 2007 (Actual)
Study Completion Date
November 6, 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
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)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The goals of this proposal are to determine the effects of hypoglycemia on the autonomic nervous system.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoglycemia
Keywords
Hypoglycemia, Autonomic Nervous System, baroreflex sensitivity, muscle sympathetic nerve activity, lower body negative pressure
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Euglycemic hyperinsulinemic clamp
Arm Type
Sham Comparator
Arm Description
participant undergoes a euglycemic hyperinsulinemic clamp
Arm Title
Hypoglycemic hyperinsulinemic clamp
Arm Type
Active Comparator
Arm Description
participant undergoes a hypoglycemic hyperinsulinemic clamp
Intervention Type
Other
Intervention Name(s)
Hypoglycemic hyperinsulinemic clamp
Intervention Type
Other
Intervention Name(s)
Euglycemic hyperinsulinemic clamp
Primary Outcome Measure Information:
Title
Change in Baroreflex Sensitivity
Description
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.
Time Frame
16 hours after euglycemic and hypoglycemic clamps as compared to baseline
Secondary Outcome Measure Information:
Title
Muscle Sympathetic Nerve Activity
Description
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.
Time Frame
16 hours after euglycemic and hypoglycemic clamps
Title
Catecholamine Response to Lower-body Negative Pressure
Description
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.
Time Frame
16 hours after euglycemic and hypoglycemic clamps
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gail K Adler, MD, PhD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Roy L Freeman, MD
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing 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.
Citations:
PubMed Identifier
18332163
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.
Results Reference
result
PubMed Identifier
19056608
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.
Results Reference
result
PubMed Identifier
22921261
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.
Results Reference
result
PubMed Identifier
20950382
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.
Results Reference
result
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Hypoglycemia and Autonomic Nervous System Function
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