RECRUITING

External Carotid Blood Flow in Individuals With Post-Bariatric Hypoglycemia

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Conditions

HypoglycemiaCerebral Blood Flowpostprandial hypoglycemiabariatric surgeryautonomic dysfunction

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

External Carotid Blood Flow Dynamics in Individuals With Post-Bariatric Hypoglycemia (PBH): Pilot Study

Quick Facts

Study Start:2025-08-01
Study Completion:2025-10-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07082478

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.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18-70 years of age, inclusive at screening.
  2. * 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.
  3. * For healthy control group: individuals without a history of upper gastrointestinal surgery and without reported symptoms of hypoglycemia.
  4. * 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.
  1. * History of coronary artery disease or presence of 2 or more risk factors including diabetes, uncontrolled hypertension, uncontrolled hyperlipidemia, and active tobacco use.
  2. * History of myocardial infarction, unstable angina or revascularization within the past 6 months.
  3. * History of syncope (unrelated to hypoglycemia) or diagnosed cardiac arrhythmia.
  4. * Documented hypoglycemia occurring in the fasting state (\> 12 hours fast).
  5. * Concurrent administration of β-blocker therapy.
  6. * Vigorous physical activity within 24 hours prior to assessment.
  7. * Seizure disorder (other than with suspect or documented hypoglycemia).
  8. * Hematocrit \< 33% (women) or \<36% (men) within the past 6 months.
  9. * History of insulinoma.
  10. * Use of central nervous system-active medications, including: antidepressants, anxiolytics, antipsychotics, stimulants, antiepileptics, sedatives and opioids.
  11. * History of severe neurologic vascular disease (e.g. cerebrovascular disease/stroke).
  12. * History of previous diseases associated with dysautonomia (e.g. multiple system atrophy, multiple sclerosis, Parkinson's disease).
  13. * Impaired hepatic function (aspartate amino transaminase and/or alanine amino transaminase \>2x upper limit of normal range), as determined within the past 6 months.
  14. * Impaired renal function (serum creatinine \>1.5 mg/dL), as determined within the past 6 months.
  15. * Serious psychiatric or substance abuse disorders (e.g. alcohol, opioid, cocaine use disorder), as judged by the study investigator.
  16. * Non-consent or inability to comply with study procedures.
  17. * Current pregnancy and/ or lactation.
  18. * Vulnerable individuals (e.g., fetuses, children, prisoners) and those judged by the investigator to be unsuitable for the study.
  19. * Individuals wearing earrings or other jewelry in the left ear who are unable or unwilling to remove them for the duration of the study.
  20. * Unwillingness to wear study masked CGM for duration of study

Contacts and Locations

Study Contact

Gabriela Londono, B.S.
CONTACT
6173091940
glondono@joslin.harvard.edu
Lily Swaine-Moore, B.S.
CONTACT
6173094468
lswainem@joslin.harvard.edu

Principal Investigator

Mary E Patti, M.D.
PRINCIPAL_INVESTIGATOR
Joslin Diabetes Center

Study Locations (Sites)

Joslin Diabetes Center
Boston, Massachusetts, 02215
United States

Collaborators and Investigators

Sponsor: Joslin Diabetes Center

  • Mary E Patti, M.D., PRINCIPAL_INVESTIGATOR, Joslin Diabetes Center

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 Registration Dates

Study Start Date2025-08-01
Study Completion Date2025-10-15

Study Record Updates

Study Start Date2025-08-01
Study Completion Date2025-10-15

Terms related to this study

Keywords Provided by Researchers

  • hypoglycemia
  • postprandial hypoglycemia
  • bariatric surgery
  • autonomic dysfunction
  • cerebral blood flow

Additional Relevant MeSH Terms

  • Hypoglycemia
  • Cerebral Blood Flow