Clinical trial NCT04430582: Cognition in Patients With Hypoglycemia, Without Diabetes
Official title: Pilot Study - Cognition in Patients With Hypoglycemia, Without Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypoglycemia
Cognition
Keywords: Executive Function
Memory
Post-Bariatric Hypoglycemia
Lead sponsor: Joslin Diabetes Center
Sponsor class: OTHER
First posted: 2020-06-12
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be recruited into 2 groups: (1) patients with hypoglycemia after upper gastrointestinal surgery (PBH), recruited from the Joslin Hypoglycemia Clinic, (2) asymptomatic post-bariatric patients without hypoglycemia, recruited from postoperative surgical clinics at Brigham and Women's Hospital or Beth Israel Hospitals.

Some participants may be recruited from other hypoglycemia studies at Joslin.

Brief 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Assessment of Immediate Verbal Memory
timeFrame: During the one day of cognitive assessment administration.
measure: Assessment of Delayed Verbal Memory
timeFrame: During the one day of cognitive assessment administration.
measure: Working Memory Assessed by the Letter Number Sequencing Scaled Score
timeFrame: During the one day of cognitive assessment administration.
Secondary outcomes:
measure: Assessment of Cognitive Flexibility Using Trails Scaled Score
timeFrame: During the one day of cognitive assessment administration.
measure: Assessment of Cognitive Flexibility Using Color-word Inference Test
timeFrame: During the one day of cognitive assessment administration.
measure: Assessment of Inhibition Using Color-word Inference Test
timeFrame: During the one day of cognitive assessment administration.
measure: Verbal Ability Cognitive Control Assessed by Letter Fluency
timeFrame: During the one day of cognitive assessment administration.
measure: Assessment of Psychomotor Speed
timeFrame: During the one day of cognitive assessment administration.
measure: Verbal Ability Cognitive Control Assessed by Category Fluency
timeFrame: During the one day of cognitive assessment administration.
measure: Verbal Ability Cognitive Flexibility, Assessed by Category Switching Scaled Score
timeFrame: During the one day of cognitive assessment administration.
measure: Verbal Ability Cognitive Control of Inhibition, Assessed by Category Switching Accuracy Scaled Score
timeFrame: During the one day of cognitive assessment administration.
measure: Lexical Processing Assessed by Letter Fluency, First Interval.
timeFrame: During one day of cognitive assessement administration.
measure: Lexical Processing as Assessed by Letter Fluency, Second Interval
timeFrame: During one day of cognitive assessement administration.
measure: Lexical Processing Assessed by Letter Fluency, Third Interval
timeFrame: During one day of cognitive assessment administration.
measure: Lexical Processing Assessed by Letter Fluency, Fourth Interval
timeFrame: During one day of cognitive assessment administration.
Other outcomes:
Locations:
city: Boston
country: United States
facility: Joslin Diabetes Center
state: Massachusetts
Study officials:
affiliation: Joslin Diabetes Center
name: Mary Elizabeth Patti, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Puleio A, Sheehan A, Musen G, Patti ME. Cognition in patients with post-bariatric hypoglycemia. Obesity (Silver Spring). 2024 Mar;32(3):466-471. doi: 10.1002/oby.23862. Epub 2023 Sep 5.