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Hyperinsulinemic Clamp for Low Blood Sugar (HypoANS-B2 Trial)
N/A
Waitlist Available
Led By Roy Freeman, MD
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time 0 and 16 hours after hyperinsulinemic hypoglycemic clamps
Awards & highlights
HypoANS-B2 Trial Summary
This trial will study how well low blood sugar affects people with diabetes who have their condition under control.
Who is the study for?
This trial is for men and women aged 18-55 with well-controlled type 2 diabetes, managed through diet, exercise, and certain medications or low-dose basal insulin. Participants should not have had recent severe low blood sugar episodes or other significant health issues like heart disease or kidney problems.Check my eligibility
What is being tested?
The study aims to understand how low blood sugar affects the body's ability to regulate blood pressure in those with controlled type 2 diabetes using a procedure called Hyperinsulinemic Hypoglycemic Clamp.See study design
What are the potential side effects?
Potential side effects may include discomfort at the infusion site, changes in blood pressure during the clamp procedure, dizziness, weakness due to induced hypoglycemia, and possible allergic reactions to drugs used.
HypoANS-B2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 55 years old.
Select...
My type 2 diabetes is managed with specific medications or low-dose insulin.
HypoANS-B2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ time 0 and 16 hours after hyperinsulinemic hypoglycemic clamps
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time 0 and 16 hours after hyperinsulinemic hypoglycemic clamps
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Modified Oxford Method Assessment of Baroreflex Function
HypoANS-B2 Trial Design
1Treatment groups
Experimental Treatment
Group I: HypoglycemiaExperimental Treatment1 Intervention
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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Who is running the clinical trial?
Brigham and Women's HospitalLead Sponsor
1,608 Previous Clinical Trials
11,469,863 Total Patients Enrolled
Beth Israel Deaconess Medical CenterOTHER
836 Previous Clinical Trials
13,010,322 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,833 Previous Clinical Trials
47,306,482 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My BMI is either below 25 or above 42, and I have Type 2 diabetes.Your blood pressure is higher than 160/100 mmHg and you have type 2 diabetes.Your creatinine levels are higher than 1.5 mg/dL.I do not have major heart, blood vessel, or systemic diseases that could affect my study participation.I am currently diagnosed with major depression.My kidney function is reduced with a GFR under 50 mL/min.I have not taken Viagra, Cialis, or similar drugs in the last 72 hours.I am between 18 and 55 years old.My type 2 diabetes is managed with specific medications or low-dose insulin.Your average blood sugar level, measured by Hemoglobin A1c, is higher than 9%.Your blood potassium level is higher than 5.2 mmol/L.I have had multiple low blood sugar episodes in the last month.I am currently taking beta-blockers or mineralocorticoid receptor antagonists.You are allergic to nitroglycerin, nitroprusside, or phenylephrine.I haven't used steroids or oral contraceptives recently.
Research Study Groups:
This trial has the following groups:- Group 1: Hypoglycemia
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are any participants being welcomed into this research program currently?
"This study, posted on September 25th 2017 and last updated July 18th 2022, is not presently enrolling participants. However, there are 147 other clinical trials with open enrollment windows at this time."
Answered by AI
Is there an opportunity for me to be a part of this investigation?
"To be considered for this research endeavour, subjects must have been diagnosed with hypoglycemia and should lie between 18 to 55 years old. The initiative is hoping to find 14 suitable participants."
Answered by AI
Is this investigation accepting participants who are older than 35?
"The age parameters for inclusion in this research are 18 years old as the lower limit and 55 as the upper bound."
Answered by AI
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