External Carotid Blood Flow in Individuals With Post-Bariatric Hypoglycemia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorJoslin Diabetes Center
About this trial
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.
Eligibility criteria
Qualifiers
Age 18-70 years of age, inclusive at screening.
Individuals able to provide informed consent and follow all study procedures, including complete daily food, activity, and symptom diaries, and willingness to provide access to medical record review.
For healthy control group: individuals without a history of upper gastrointestinal surgery and without reported symptoms of hypoglycemia.
Individuals with access to personal iPhone running operating system 16 (iOS) or later versions (not feasible for Android platform users) and a password-protected home Wi-Fi network.
Disqualifiers
History of coronary artery disease or presence of 2 or more risk factors including diabetes, uncontrolled hypertension, uncontrolled hyperlipidemia, and active tobacco use.
History of myocardial infarction, unstable angina or revascularization within the past 6 months.
History of syncope (unrelated to hypoglycemia) or diagnosed cardiac arrhythmia.
Documented hypoglycemia occurring in the fasting state (> 12 hours fast).
Trial design
Treatments tested in this trial
- in-ear device measuring blood flow
Treatment groups
5 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov