Status:
COMPLETED
Cognition in Patients With Hypoglycemia, Without Diabetes
Lead Sponsor:
Joslin Diabetes Center
Conditions:
Hypoglycemia
Cognition
Eligibility:
All Genders
18-70 years
Brief Summary
The purpose of this study is to determine if there are differences in cognitive function (thinking) in individuals who have recurrent hypoglycemia (low blood sugars) following Roux-en-Y gastric bypass...
Detailed Description
This study will test the hypothesis that a history of recurrent hypoglycemia following gastric bypass is associated with differences in cognition (thinking), by analyzing results of cognitive testing ...
Eligibility Criteria
Inclusion
- Age 18-70 years of age, inclusive, at screening.
- Willingness to provide informed consent and attend one study visit.
- For hypoglycemia after upper GI surgery group: Males or females diagnosed with ongoing post upper GI surgery hypoglycemia, with prior episodes of neuroglycopenia, unresponsive to dietary intervention.
- For hypoglycemia without a history of upper gastrointestinal surgery group: Males or females diagnosed with ongoing hypoglycemia with prior episodes of neuroglycopenia, and without a history of prediabetes, diabetes, or upper GI surgery.
- For post-bariatric without hypoglycemia group: Males or females with history of bariatric surgery, and no history of symptomatic hypoglycemia.
- For non-surgical controls only: Males or females with no history of upper GI surgery and no history of hypoglycemia, prediabetes, or diabetes.
Exclusion
- Active treatment with any diabetes medications, except for acarbose.
- History of cerebrovascular accident.
- History of a traumatic brain injury not related to hypoglycemia.
- Active depression.
- Active alcohol abuse or substance abuse.
- Known insulinoma, gastrinoma or other neuroendocrine tumor.
- Having undergone same / similar cognitive assessments within the last calendar year.
- There will be no involvement of special vulnerable populations such as fetuses, neonates, pregnant women, children, prisoners, institutionalized or incarcerated individuals, or others who may be considered vulnerable populations.
Key Trial Info
Start Date :
August 4 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 4 2021
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT04430582
Start Date
August 4 2020
End Date
August 4 2021
Last Update
November 4 2024
Active Locations (1)
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1
Joslin Diabetes Center
Boston, Massachusetts, United States, 02215