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Hypoglycemia and Autonomic Nervous System Function- B2 (HypoANS-B2)

Primary Purpose

Hypoglycemia, Type2 Diabetes

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hyperinsulinemic Hypoglycemic Clamp
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypoglycemia

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Brigham and Women's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hypoglycemia

Arm Description

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.

Outcomes

Primary Outcome Measures

Modified Oxford Method Assessment of Baroreflex Function
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)

Secondary Outcome Measures

Full Information

First Posted
January 30, 2018
Last Updated
July 18, 2022
Sponsor
Brigham and Women's Hospital
Collaborators
Beth Israel Deaconess Medical Center, National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT03422471
Brief Title
Hypoglycemia and Autonomic Nervous System Function- B2
Acronym
HypoANS-B2
Official Title
Hypoglycemia and Autonomic Nervous System Function
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 25, 2017 (Actual)
Primary Completion Date
December 28, 2023 (Anticipated)
Study Completion Date
October 28, 2024 (Anticipated)

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 Heart, Lung, and Blood Institute (NHLBI)

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
We will study the effect of hypoglycemia (low blood sugar) on baroreflex sensitivity in participants with well controlled type 2 diabetes.
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. .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoglycemia, Type2 Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hypoglycemia
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Hyperinsulinemic Hypoglycemic Clamp
Intervention Description
Participants will receive two 90 minute sessions of hypoglycemia. Baroreflex sensitivity will be assessed before, after, and during the sessions.
Primary Outcome Measure Information:
Title
Modified Oxford Method Assessment of Baroreflex Function
Description
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)
Time Frame
Time 0 and 16 hours after hyperinsulinemic hypoglycemic clamps

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gail Adler, MD/PhD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Roy Freeman, MD
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
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
Yes
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.
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.

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Hypoglycemia and Autonomic Nervous System Function- B2

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