Cognition in Patients With Hypoglycemia, Without Diabetes

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

22 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-04

Study Completion Date

2021-08-04

Brief Summary

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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.

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Detailed Description

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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 in post-gastric bypass individuals with a history of hypoglycemia as compared to those without known hypoglycemia.

This pilot study will identify cognitive domains of interest, 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: premorbid intelligence, memory, language, executive function, and psychomotor speed.

Conditions

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Hypoglycemia Cognition

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Hypoglycemia after gastric bypass surgery - post-bariatric hypoglycemia (PBH)

Participants with PBH, recruited from the Joslin Hypoglycemia Clinic and from other hypoglycemia studies at Joslin.

Cognitive Assessment (not diagnostic)

Intervention Type OTHER

Cognitive testing will assess premorbid intelligence, working memory and attention, verbal memory and delayed memory, executive function, and psychomotor speed.

ECG

Intervention Type DIAGNOSTIC_TEST

ECG will take place during screening visit.

Post-gastric bypass participants without a history of hypoglycemia

Participants with a history of Roux-en-Y gastric bypass, but without a diagnosis of hypoglycemia, or symptoms of hypoglycemia, recruited by advertisement flyers at postoperative surgical clinics at local hospitals (such as Brigham and Women's and Beth Israel Deaconess Hospitals), research match, and from other hypoglycemia studies at Joslin.

Cognitive Assessment (not diagnostic)

Intervention Type OTHER

Cognitive testing will assess premorbid intelligence, working memory and attention, verbal memory and delayed memory, executive function, and psychomotor speed.

ECG

Intervention Type DIAGNOSTIC_TEST

ECG will take place during screening visit.

Interventions

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Cognitive Assessment (not diagnostic)

Cognitive testing will assess premorbid intelligence, working memory and attention, verbal memory and delayed memory, executive function, and psychomotor speed.

Intervention Type OTHER

ECG

ECG will take place during screening visit.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Electrocardiogram (ECG)

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No