HypoglycemiaHypoANSNCT01816893
Hypoglycemia and Autonomic Nervous System Function
A study testing Hypoglycemic hyperinsulinemic clamp and Euglycemic hyperinsulinemic clamp in people with Hypoglycemia, run by Brigham and Women's Hospital at 2 sites in United States.
Trial summary
The goals of this proposal are to determine the effects of hypoglycemia on the autonomic nervous system. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypoglycemia
- What is being tested?
- Hypoglycemic hyperinsulinemic clamp and Euglycemic hyperinsulinemic clamp
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Jun 2004to 6 Nov 2007
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers
- Males and females age 18 to 50 years
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
The goals of this proposal are to determine the effects of hypoglycemia on the autonomic nervous system.
- Conditions
- Hypoglycemia
- Being tested
- Hypoglycemic hyperinsulinemic clamp, Euglycemic hyperinsulinemic clamp
- Keywords
- Hypoglycemia, Autonomic Nervous System, baroreflex sensitivity, muscle sympathetic nerve activity, lower body negative pressure
- Medical subject headings
- Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypoglycemic hyperinsulinemic clampOther
Euglycemic hyperinsulinemic clampOther
| Study group | Role | What they receive |
|---|---|---|
| Euglycemic hyperinsulinemic clamp | Sham comparator | participant undergoes a euglycemic hyperinsulinemic clamp Receives: Other: Euglycemic hyperinsulinemic clamp |
| Hypoglycemic hyperinsulinemic clamp | Active comparator | participant undergoes a hypoglycemic hyperinsulinemic clamp Receives: Other: Hypoglycemic hyperinsulinemic clamp |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 16 hours after euglycemic and hypoglycemic clamps as compared to baseline
Secondary outcomes (2)
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.
Measured: 16 hours after 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.
Measured: 16 hours after euglycemic and hypoglycemic clamps
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2013 (estimated)
- Study start8 Jun 2004
- Primary completion6 Nov 2007
- Study completion6 Nov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HypoglycemiaStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- 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)
- Responsible party
- Principal investigator, Gail Adler, Brigham and Women's Hospital
- Investigators
- Gail K Adler, MD, PhD, Principal investigator, Brigham and Women's HospitalRoy L Freeman, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01816893
- Sponsor's protocol ID
- 2004P001233
- Other IDs
- R01DK063296, M01RR002635
- Acronym
- HypoANS
- Status last verified
- Mar 2018
- First submitted
- 20 Mar 2013
- Last updated
- 2 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 18332163Adler 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.
PubMed 19056608Gibbons 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.
PubMed 22921261Adler 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.
PubMed 20950382
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypoglycemia and Autonomic Nervous System Function
- ClinicalTrials.gov ID
- NCT01816893
- Acronym / sponsor ID
- HypoANS / 2004P001233
- Conditions
- Hypoglycemia
- Keywords
- Hypoglycemia, Autonomic Nervous System, baroreflex sensitivity, muscle sympathetic nerve activity, lower body negative pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- 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)
- Study start
- 8 Jun 2004 (actual)
- Primary completion
- 6 Nov 2007 (actual)
- Study completion
- 6 Nov 2007 (actual)
- First posted
- 22 Mar 2013 (estimated)
- Results
- Posted 6 Mar 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goals of this proposal are to determine the effects of hypoglycemia on the autonomic nervous system.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Euglycemic hyperinsulinemic clamp | Sham comparator | Other: Euglycemic hyperinsulinemic clampparticipant undergoes a euglycemic hyperinsulinemic clamp |
| Hypoglycemic hyperinsulinemic clamp | Active comparator | Other: Hypoglycemic hyperinsulinemic clampparticipant undergoes a hypoglycemic hyperinsulinemic clamp |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy volunteers
- Males and females age 18 to 50 years
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypoglycemic hyperinsulinemic clamp | Other | Hypoglycemic hyperinsulinemic clamp |
| Euglycemic hyperinsulinemic clamp | Other | Euglycemic hyperinsulinemic clamp |
Primary outcome
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.
2 secondary outcomes
Muscle Sympathetic Nerve Activity
Time frame: 16 hours after euglycemic and hypoglycemic clamps
Catecholamine Response to Lower-body Negative Pressure
Time frame: 16 hours after euglycemic and hypoglycemic clamps
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 18332163Dotson 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 publication: PubMed 19056608Adler 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 publication: PubMed 22921261Gibbons 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 publication: PubMed 20950382Adler 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gail K Adler, MD, PhD principal investigator
Brigham and Women's Hospital
Roy L Freeman, MD principal investigator
Beth Israel Deaconess Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypoglycemic hyperinsulinemic clamp and Euglycemic hyperinsulinemic clamp in people with Hypoglycemia, run by Brigham and Women's Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Mar 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Baroreflex Sensitivity (time frame: 16 hours after euglycemic and hypoglycemic clamps as compared to baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01816893, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2018.