Cognition in Patients With Hypoglycemia, Without Diabetes

NCT04430582 | Completed Results DMC

• 1 other identifier: 00000098
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypoglycemia; Cognition

Keywords

Executive Function; Memory; Post-Bariatric Hypoglycemia

Outcome Measures

Primary Outcomes (3)

• Assessment of Immediate Verbal Memory

  Rey Auditory Verbal Learning Test (RAVLT) immediate recall accuracy scores was used to measure immediate verbal memory. Scores for this assessment were compared between groups. Scores for this assessment range 0 to 69, with a higher score indicating a superior immediate verbal memory. Wilcoxon rank-sum tests was used to examine differences between groups.

  During the one day of cognitive assessment administration.

• Assessment of Delayed Verbal Memory

  RAVLT 20 minute recall accuracy scores, was used to measure delayed memory and was compared between groups. Scores for this assessment range 0 to 15, with a higher score indicating less delays in memory. Wilcoxon rank-sum tests was used to examine differences between groups.

  During the one day of cognitive assessment administration.

• Working Memory Assessed by the Letter Number Sequencing Scaled Score

  Letter-Number Sequencing subtest from the Wechsler Memory Scale III scaled scores were used to measure working memory and were compared between groups. Wilcoxon rank-sum test was used to examine differences between groups. Scores for this assessment range 1 to 19, with a higher score indicating a superior working memory.

  During the one day of cognitive assessment administration.

Secondary Outcomes (12)

• Assessment of Cognitive Flexibility Using Trails Scaled Score

  During the one day of cognitive assessment administration.

• Assessment of Cognitive Flexibility Using Color-word Inference Test

  During the one day of cognitive assessment administration.

• Assessment of Inhibition Using Color-word Inference Test

  During the one day of cognitive assessment administration.

• Verbal Ability Cognitive Control Assessed by Letter Fluency

  During the one day of cognitive assessment administration.

• Assessment of Psychomotor Speed

  During the one day of cognitive assessment administration.

Study Arms (2)

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.

Other: Cognitive Assessment (not diagnostic); Diagnostic Test: ECG

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.

Other: Cognitive Assessment (not diagnostic); Diagnostic Test: ECG

Interventions

Cognitive Assessment (not diagnostic) OTHER

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

Hypoglycemia after gastric bypass surgery - post-bariatric hypoglycemia (PBH); Post-gastric bypass participants without a history of hypoglycemia

ECG DIAGNOSTIC_TEST

ECG will take place during screening visit.

Also known as: Electrocardiogram (ECG)

Hypoglycemia after gastric bypass surgery - post-bariatric hypoglycemia (PBH); Post-gastric bypass participants without a history of hypoglycemia

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Joslin Diabetes Center: lead

Study Sites (1)

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

• 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.

  PMID: 37667837 RESULT

MeSH Terms

Conditions

Hypoglycemia

Interventions

Electrocardiography

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Limitations and Caveats

Limitations of this pilot study include its small sample size, cross-sectional approach, and low power (increased risk of type 2 error). The battery of tests utilized was specifically limited to maintain a total assessment time of no more than one hour, in order to reduce the impact of participant fatigue.

Results Point of Contact

• Title: Mary Elizabeth Patti, MD
• Organization: Joslin Diabetes Center

MaryElizabeth.Patti@Joslin.Harvard.edu

6173091966

Study Officials

• Mary Elizabeth Patti, MD

  Joslin Diabetes Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2020
• First Posted: June 12, 2020
• Study Start: August 4, 2020
• Primary Completion: August 4, 2021
• Study Completion: August 4, 2021
• Last Updated: November 4, 2024
• Results First Posted: November 4, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)