Pilot Study - Cognition in Patients With Hypoglycemia Without Diabetes

STATUS

Recruiting
days left to enroll

33
participants needed

80
sponsor

Joslin Diabetes Center

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Updated on 19 February 2024

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diabetes

hypoglycemia

cognitive assessment

dietary intervention

gastrointestinal surgery

bariatric surgery

neuroglycopenia

Summary

Show definitions

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 Identifier	NCT04430582
Sponsor	Joslin Diabetes Center
Last Modified on	19 February 2024

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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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Step 2 Get screened

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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Pilot Study - Cognition in Patients With Hypoglycemia Without Diabetes