- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03422471
Hypoglycemia and Autonomic Nervous System Function- B2 (HypoANS-B2)
July 18, 2022 updated by: Gail Kurr Adler, Brigham and Women's Hospital
Hypoglycemia and Autonomic Nervous System Function
We will study the effect of hypoglycemia (low blood sugar) on baroreflex sensitivity in participants with well controlled type 2 diabetes.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
Participants are admitted for two days and two nights to an inpatient clinical research center for performance of study procedures.
On Day 1, two hyperinsulinemic hypoglycemic (50 mg/dl) clamps are performed - an AM clamp from about 9 to 11 am and a PM clamp from about 1 to 3 pm.. Modified Oxford procedures are performed in duplicate at five time points -- before the AM clamp, during the AM clamp, before the PM clamp, during the PM clamp, and the morning of Day 2 (about 16 hrs after completion of the the PM clamp).
The Modified Oxford procedure involves the sequential intravenous administration of nitroprusside and phenylephrine with assessment of blood pressure and heart rate by finapress.
Baroreflex sensitivity is the relationship of changes in heart rate to changes in blood pressure. .
Study Type
Interventional
Enrollment (Anticipated)
14
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Brigham and Women's Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Males and females age 18 to 55 years
- Type 2 Diabetes Mellitus controlled by diet, exercise and non-insulin glycemic control agents (metformin, thiazolidinediones, sulfonylureas, dipeptidyl peptidase-4 inhibitors, sodium-glucose co-transporter 2 inhibitors, alpha-glucosidase inhibitors or glucagon-like peptide-1 receptor agonist) or basal insulin at doses less than or equal to 0.3 units/ kg per day.
Exclusion Criteria:
- Hemoglobin A1c > 9% for type 2 diabetes
- Recurrent hypoglycemic episodes within the past month
- BMI < 25 or > 42 (Type 2 diabetes only)
- Pregnancy
- Lactation
- Clinically significant coronary artery, cerebrovascular, or peripheral vascular disease, or presence of systemic illness that might affect autonomic function. Such illnesses include congestive heart failure, renal, pulmonary, hepatic disease, anemia, malignancies, untreated thyroid disease, and alcoholism.
- Current major depressive illness
- In all subjects, any individuals on oral, injected, inhaled or topical corticosteroids within the last year or oral contraceptives within the past 3 months will be excluded.
- Known hypersensitivity to nitroglycerin, nitroprusside and/or phenylephrine.
- Blood pressure > 160/100 mmHg (applies to participants with T2 diabetes)
- Creatinine > 1.5 mg/dL
- Serum potassium >5.2 mmol/L
- Estimated GFR < 50 mL/min
- Use of Viagra, Cialis, and similar drugs within 72 hours of admission.
- Use of beta-blockers or mineralocorticoid receptor antagonists
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Hypoglycemia
Participants are exposed to two 90 minute episodes of hypoglycemia (50 mg/dl) through a hyperinsulinemic hypoglycemic clamp.
Baroreflex sensitivity will be assessed before, during, and 16 hours after the hypoglycemia.
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Participants will receive two 90 minute sessions of hypoglycemia.
Baroreflex sensitivity will be assessed before, after, and during the sessions.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Modified Oxford Method Assessment of Baroreflex Function
Time Frame: Time 0 and 16 hours after hyperinsulinemic hypoglycemic clamps
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Change in baroreflex sensitivity between the first assessment (pre-AM clamp on Day 1) and the final assessment (AM of Day 2, about 16 hours after the PM clamp)
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Time 0 and 16 hours after hyperinsulinemic hypoglycemic clamps
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 25, 2017
Primary Completion (Anticipated)
December 28, 2023
Study Completion (Anticipated)
October 28, 2024
Study Registration Dates
First Submitted
January 30, 2018
First Submitted That Met QC Criteria
January 30, 2018
First Posted (Actual)
February 5, 2018
Study Record Updates
Last Update Posted (Actual)
July 20, 2022
Last Update Submitted That Met QC Criteria
July 18, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2004P001233-B2
- R01HL111465 (U.S. NIH Grant/Contract)
- K24HL103845 (NIH)
- UL1TR001102 (NIH)
- T32HL007609 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD 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.
IPD Sharing Time Frame
Data will be shared after completion of study and initial publications which we anticipate to be within 18 months of the final participant completing the study protocol.
IPD Sharing Access Criteria
Access to this information must be approved by the Partners IRB.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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