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Pilot Study - Cognition in Patients With Hypoglycemia Without Diabetes

Pilot Study - Cognition in Patients With Hypoglycemia Without Diabetes

Recruiting
18-70 years
All
Phase N/A

Overview

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.

Eligibility

Inclusion Criteria:

  1. Age 18-70 years of age, inclusive, at screening.
  2. Willingness to provide informed consent and attend one study visit.
  3. 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.
  4. 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.
  5. For post-bariatric without hypoglycemia group: Males or females with history of bariatric surgery, and no history of symptomatic hypoglycemia.
  6. 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:

  1. Active treatment with any diabetes medications, except for acarbose.
  2. History of cerebrovascular accident.
  3. History of a traumatic brain injury not related to hypoglycemia.
  4. Active depression.
  5. Active alcohol abuse or substance abuse.
  6. Known insulinoma, gastrinoma or other neuroendocrine tumor.
  7. 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.

Study details
    Hypoglycemia
    Hypocalcemia
    Cognition

NCT04430582

Joslin Diabetes Center

16 February 2024

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