External Carotid Blood Flow Dynamics in Individuals With Post-Bariatric Hypoglycemia (PBH): Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Rate of study completion
研究概览
简要总结
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.
详细描述
Visit 1 (Screening) This visit will last about 2 hours. Participants will be asked to come to Joslin Diabetes Center.
During the screening visit, a study team member will go over the informed consent form with participants and will explain why this study is being done and the study procedures involved. Participants will have to sign the consent form before any study related procedures take place. After participants sign the consent, the following procedures will be done to ensure eligibility and that it is safe to be part of the study.
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Review medical history by the study doctor.
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Participants will be asked to sign a release of information form so that the investigators may obtain additional information about medical history from prior physicians and hospitals. Medical records including laboratory results (within the last 6 months) will be reviewed by the study doctor.
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Physical examination, vital signs and anthropometrics (blood pressure, heart rate, temperature, height and weight) and an otoscopic exam (a look inside the external ear).
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Urine pregnancy test (if participant is a female of child bearing potential) that must be negative in order to continue participation.
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Questionnaires: Investigators will ask participants to fill out several questionnaires that will help the investigators assess any symptoms of low blood sugar or autonomic symptoms:
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Edinburgh Hypoglycemia Symptom Scale (EHSS)
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Dumping Symptom Rating Scale (DSRS) questionnaire
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Composite Autonomic Symptom Score (COMPASS 31)
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Orthostatic Hypotension Questionnaire (OHQ)
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Devices: If the participant is eligible, a member of the study team will place the following devices. The participant will wear both devices for 10 days (24 hours per day) · Lumia Health: A small in-ear wearable device will be placed to monitor the blood flow to the head. The study team will make sure it fits comfortably and show the participant how to use it properly. A member of the Lumia team may be present during the placement of the device in order to assist the study team with choosing the best size of the device to match the shape of the participant's ear. If the participant is uncomfortable with this, study team members will be able to perform this procedure (after receiving instructions from a Lumia team member).
Procedure: (1) Removing earrings or jewelry if needed and cleaning the outer ear to ensure a secure fit. (2) Positioning the device on the frontal surface of the left ear cartilage. (3) Adjusting it to fit comfortably. If participant experiences any discomfort during placement, they will be asked to inform the study team.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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).
- •Concurrent administration of β-blocker therapy.
- •Vigorous physical activity within 24 hours prior to assessment.
- •Seizure disorder (other than with suspect or documented hypoglycemia).
- •Hematocrit < 33% (women) or <36% (men) within the past 6 months.
- •History of insulinoma.
- •Use of central nervous system-active medications, including: antidepressants, anxiolytics, antipsychotics, stimulants, antiepileptics, sedatives and opioids.
- •History of severe neurologic vascular disease (e.g. cerebrovascular disease/stroke).
- •History of previous diseases associated with dysautonomia (e.g. multiple system atrophy, multiple sclerosis, Parkinson's disease).
- •Impaired hepatic function (aspartate amino transaminase and/or alanine amino transaminase >2x upper limit of normal range), as determined within the past 6 months.
- •Impaired renal function (serum creatinine >1.5 mg/dL), as determined within the past 6 months.
- •Serious psychiatric or substance abuse disorders (e.g. alcohol, opioid, cocaine use disorder), as judged by the study investigator.
- •Non-consent or inability to comply with study procedures.
- •Current pregnancy and/ or lactation.
- •Vulnerable individuals (e.g., fetuses, children, prisoners) and those judged by the investigator to be unsuitable for the study.
- •Individuals wearing earrings or other jewelry in the left ear who are unable or unwilling to remove them for the duration of the study.
- •Unwillingness to wear study masked CGM for duration of study
结局指标
主要结局
Rate of study completion
时间窗: up to 10 days
Feasibility as determined by rate of study completion
Number of days with viable data (complete recordings)
时间窗: up to 10 days
Feasibility as determined by number of days with viable data (complete recordings)
Participant-reported outcome scores
时间窗: up to 10 days
Scores from a qualitative survey (Patient-Reported Outcomes for In-Ear Device, adapted from the COPROD questionnaire (COnfort des PROtections auDitives/COmfort of hearing PROtection Devices) of patient acceptance of in-ear wearable device at study completion.
Correlation between external cerebral blood flow (eCBF) (arbitrary units) and corresponding sensor glucose values (mg/dL)
时间窗: up to 10 days
Determine correlation between external cerebral blood flow (arbitrary units) and nearest sensor glucose levels (mg/dL), summed over the length of wear for each participant
Correlation between rate of change in eCBF (arbitrary units) and rate of change in sensor glucose (mg/dL)
时间窗: up to 10 days
Determine correlation between rate of change from baseline in eCBF and rate of change in sensor glucose values, summed over the length of wear for each participant
次要结局
- Success of data transfer from ear device to study database(up to 10 days)
- Percentage of time with successful blood flow (arbitrary units) data collection(up to 10 days)
- Change in eCBF over 3 hours after meal initiation(up to 10 days)
- Change in eCBF during physical activity, measured by integrated eCBF changes from onset of activity to completion of activity.(up to 10 days)
- Correlation of hypoglycemia symptom score, measured by the Edinburgh Hypoglycemia Scale (EHHS) at study entry, with the frequency of low sensor glucose readings (% of time with sensor glucose < 70 mg/dL)(up to 10 days)
- Correlation of dysautonomia symptom score, measured by the COMPASS survey at study entry, with the frequency of low sensor glucose readings (% of time with sensor glucose <70 mg/dL)(up to 10 days)
- Correlation of hypoglycemia symptom score, measured by the Edinburgh Hypoglycemia Score at study entry, with the coefficient of variation in eCBF (SD/mean) over the duration of the study(up to 10 days)
- Correlation of dysautonomia symptom score, measured by the COMPASS survey at study entry, with the coefficient of variation in eCBF (SD/mean) over the duration of the study(up to 10 days)
研究者
Mary Elizabeth Patti
Senior Investigator
Joslin Diabetes Center