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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK063296 | U.S. NIH Grant/Contract | View source | |
| M01RR002635 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Beth Israel Deaconess Medical Center | OTHER |
| National Institutes of Health (NIH) | NIH |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The goals of this proposal are to determine the effects of hypoglycemia on the autonomic nervous system.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Euglycemic hyperinsulinemic clamp | Sham Comparator | participant undergoes a euglycemic hyperinsulinemic clamp |
|
| Hypoglycemic hyperinsulinemic clamp | Active Comparator | participant undergoes a hypoglycemic hyperinsulinemic clamp |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypoglycemic hyperinsulinemic clamp | Other |
| ||
| Euglycemic hyperinsulinemic clamp |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Catecholamine Response to Lower-body Negative Pressure |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Gail K Adler, MD, PhD | Brigham and Women's Hospital | Principal Investigator |
| Roy L Freeman, MD | Beth Israel Deaconess Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02115 | United States | ||
| Brigham and Women's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18332163 | Result | 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. | |
| 19056608 | Result | 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. |
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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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| ID | Title | Description |
|---|---|---|
| FG000 | Euglycemic Clamp/ Washout Period/ Hypoglycemic Clamp |
|
| FG001 | Hypoglycemic Clamp/ Washout Period/ Euglycemic Clamp |
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| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Euglycemic Clamp/ Hypoglycemic Clamp |
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| Washout Period |
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| Hypoglycemic Clamp/ Euglycemic Clamp |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Euglycemic Clamp/ Washout Period/ Hypoglycemic Clamp |
|
| BG001 | Hypoglycemic Clamp/ Washout Period/ Euglycemic Clamp |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 20 subjects completed both arms, but only 18 had the change in BRS outcome for both arms. | Posted | Mean | Standard Deviation | ms/mmHg | 16 hours after euglycemic and hypoglycemic clamps as compared to baseline |
|
Adverse event data was collected for about a week (during each 3-day assessment and for a few days afterwards).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Euglycemic Clamp | Participant undergoes a euglycemic hyperinsulinemic clamp | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Gail Kurr Adler | Brigham and Women's Hospital | (617) 732-8742 | gadler@bwh.harvard.edu |
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| ID | Term |
|---|---|
| D007003 | Hypoglycemia |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| National Center for Research Resources (NCRR) |
| NIH |
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| Other |
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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 |
| Boston |
| Massachusetts |
| 02115 |
| United States |
| 22921261 | Result | 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. |
| 20950382 | Result | 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. |
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| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Hypoglycemic Clamp |
participant undergoes a hypoglycemic hyperinsulinemic clamp Hypoglycemia |
|
|
| 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. | 20 subjects completed both arms, but only 5 had the muscle sympathetic nerve activity outcome for both arms. | Posted | Mean | Standard Deviation | bursts/ minute | 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. | Of the 22 subjects who started the protocol, 20 completed both arms. | Posted | Mean | Standard Deviation | nmol/L | 16 hours after euglycemic and hypoglycemic clamps |
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|
|
| 22 |
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | Hypoglycemic Clamp | Participant undergoes a hypoglycemic hyperinsulinemic clamp | 0 | 20 | 0 | 20 | 0 | 20 |
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