Cognition in Patients With Hypoglycemia, Without Diabetes (NCT04430582) | Clinical Trial Compass
CompletedNot Applicable
Cognition in Patients With Hypoglycemia, Without Diabetes
United States22 participantsStarted 2020-08-04
Plain-language 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, compared with individuals who have also had a Roux-en-Y gastric bypass but do not have hypoglycemia.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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.
What they're measuring
1
Assessment of Immediate Verbal Memory
Timeframe: During the one day of cognitive assessment administration.
2
Assessment of Delayed Verbal Memory
Timeframe: During the one day of cognitive assessment administration.
3
Working Memory Assessed by the Letter Number Sequencing Scaled Score
Timeframe: During the one day of cognitive assessment administration.