Pilot Study - Cognition in Patients With Hypoglycemia Without Diabetes

  • STATUS
    Recruiting
  • days left to enroll
    7
  • participants needed
    80
  • sponsor
    Joslin Diabetes Center
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Updated on 16 February 2024
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hypoglycemia
cognitive assessment
dietary intervention
gastrointestinal surgery
bariatric surgery
neuroglycopenia
diabetes

Summary

The purpose of this study is to determine if there is a relationship between recurrent hypoglycemia (low blood sugar) and cognition (thinking) in individuals who have a history of hypoglycemia, but do not have pre-diabetes or diabetes.

This study will analyze whether recurrent hypoglycemia is associated with differences in cognition (thinking), and if individuals with a history of hypoglycemia perform less well on cognitive assessments compared to individuals without known hypoglycemia.

Description

This study will test the hypothesis that recurrent hypoglycemia is associated with differences in cognition (thinking), by analyzing results of cognitive testing in individuals with a history of hypoglycemia as compared with those without known hypoglycemia.

This pilot study will identify cognitive domains of interest in participants with hypoglycemia, as well as inform the development of a future battery of assessments, which could be replicated in a larger sample. Cognitive domains which will be assessed include: memory, language, executive function, and psychomotor speed.

Details
Condition Hypoglycemia, Hypocalcemia, Cognition
Age 18years - 70years
Treatment ECG, Cognitive Assessment (not diagnostic)
Clinical Study IdentifierNCT04430582
SponsorJoslin Diabetes Center
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

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
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
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