Actively Recruiting
External Carotid Blood Flow in Individuals With Post-Bariatric Hypoglycemia
Led by Joslin Diabetes Center · Updated on 2025-11-28
5
Participants Needed
1
Research Sites
59 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a pilot study (small-scale study) that aims to understand more about how blood flow changes in people who have low blood sugar after bariatric surgery (post-bariatric hypoglycemia) compared to those who have had surgery without hypoglycemia, those who have hypoglycemia without surgery, or those who do not experience low blood sugar. This study has two phases. This is the first phase, and the purpose is to test comfort and feasibility of a novel in-ear wearable device (Lumia Health) that measures blood flow changes to the head. Information from the study will help the investigators determine if the device is suitable to be used in the second phase of the study.
CONDITIONS
Official Title
External Carotid Blood Flow in Individuals With Post-Bariatric Hypoglycemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-70 years at screening
- Ability to provide informed consent and follow all study procedures, including keeping daily food, activity, and symptom diaries
- Willingness to allow access to medical records for review
- For healthy controls: no history of upper gastrointestinal surgery and no reported hypoglycemia symptoms
- Access to a personal iPhone running iOS 16 or later and a password-protected home Wi-Fi network
You will not qualify if you...
- History of coronary artery disease or two or more risk factors such as diabetes, uncontrolled high blood pressure, uncontrolled high cholesterol, or current tobacco use
- Heart attack, unstable angina, or revascularization within the past 6 months
- History of fainting unrelated to low blood sugar or diagnosed irregular heart rhythm
- Documented fasting low blood sugar (more than 12 hours fast)
- Current use of beta-blocker medication
- Vigorous physical activity within 24 hours before assessment
- Seizure disorder not related to low blood sugar
- Low hematocrit levels within the past 6 months (less than 33% for women, less than 36% for men)
- History of insulinoma
- Use of central nervous system-active medications including antidepressants, anxiolytics, antipsychotics, stimulants, antiepileptics, sedatives, or opioids
- History of severe neurological vascular diseases like stroke
- History of diseases causing autonomic nervous system dysfunction such as multiple system atrophy, multiple sclerosis, or Parkinson's disease
- Impaired liver function (liver enzymes more than twice normal) within past 6 months
- Impaired kidney function (serum creatinine over 1.5 mg/dL) within past 6 months
- Serious psychiatric or substance abuse disorders
- Unable or unwilling to consent or comply with study procedures
- Current pregnancy or breastfeeding
- Vulnerable individuals such as fetuses, children, prisoners, or those deemed unsuitable by investigators
- Wearing earrings or jewelry in the left ear and unable or unwilling to remove them for the study duration
- Unwillingness to wear the study continuous glucose monitor for the study period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Joslin Diabetes Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
Research Team
G
Gabriela Londono, B.S.
CONTACT
L
Lily Swaine-Moore, B.S.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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