N/A N=16

Cognition in Patients With Hypoglycemia, Without Diabetes

Hypoglycemia · Cognition

Bottom Line

View on ClinicalTrials.gov: NCT04430582 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2024

Primary outcome: Primary: Assessment of Immediate Verbal Memory — 50; 48 RAVLT scores on a scale (range 0 to 69) — p=0.90

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: Cognitive Assessment (not diagnostic) (Other); ECG (Diagnostic_test)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Joslin Diabetes Center
Primary completion: Aug 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Assessment of Immediate Verbal Memory	50; 48	0.90
PRIMARY Assessment of Delayed Verbal Memory	9; 10	0.24
PRIMARY Working Memory Assessed by the Letter Number Sequencing Scaled Score	10; 10	0.74
SECONDARY Assessment of Cognitive Flexibility Using Trails Scaled Score	12; 11	0.51
SECONDARY Assessment of Cognitive Flexibility Using Color-word Inference Test	11; 12	0.70
SECONDARY Assessment of Inhibition Using Color-word Inference Test	10; 11	0.95
SECONDARY Verbal Ability Cognitive Control Assessed by Letter Fluency	8; 12	0.48
SECONDARY Assessment of Psychomotor Speed	100; 102	0.85
SECONDARY Verbal Ability Cognitive Control Assessed by Category Fluency	10; 14	0.01 sig
SECONDARY Verbal Ability Cognitive Flexibility, Assessed by Category Switching Scaled Score	10; 15	0.01 sig
SECONDARY Verbal Ability Cognitive Control of Inhibition, Assessed by Category Switching Accuracy Scaled Score	10; 14	0.03 sig
SECONDARY Lexical Processing Assessed by Letter Fluency, First Interval.	10; 13	0.03 sig
SECONDARY Lexical Processing as Assessed by Letter Fluency, Second Interval	10; 11	0.30
SECONDARY Lexical Processing Assessed by Letter Fluency, Third Interval	10; 12	0.045 sig
SECONDARY Lexical Processing Assessed by Letter Fluency, Fourth Interval	8; 11	0.37

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04430582). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.