Cognition, Hypoglycemia
Conditions
Keywords
Executive Function, Memory, Post-Bariatric Hypoglycemia
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.
Interventions
Cognitive testing will assess premorbid intelligence, working memory and attention, verbal memory and delayed memory, executive function, and psychomotor speed.
DIAGNOSTIC_TESTECG
ECG will take place during screening visit.
Sponsors
Joslin Diabetes Center
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Immediate Verbal Memory | During the one day of cognitive assessment administration. | 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. |
| Assessment of Delayed Verbal Memory | During the one day of cognitive assessment administration. | 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. |
| Working Memory Assessed by the Letter Number Sequencing Scaled Score | During the one day of cognitive assessment administration. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Verbal Ability Cognitive Control Assessed by Letter Fluency | During the one day of cognitive assessment administration. | DKEFS Letter Fluency Task will be used to assess the verbal functioning cognitive control ability component of executive function. Scores are derived from the number of unique, correct words. Wilcoxon rank-sum test was used to examine differences between groups. Normative scores for this assessment range 1-19 (mean of 10, and standard deviation of 3), and a higher score indicates superior verbal functioning cognitive control ability. |
| Assessment of Psychomotor Speed | During the one day of cognitive assessment administration. | The grooved pegboard test is a manipulative dexterity task that assesses psychomotor speed, fine motor control, and rapid-visual motor coordination. Participants were asked to insert 25 grooved pegs into holes within the given time limit up to 300 seconds (the score upper limit is thus 300). Time taken to complete the test has been found to be inversely correlated with cognitive ability; therefore, a higher score represents an inferior score. Wilcoxon rank-sum test was used to examine differences between groups. |
| Verbal Ability Cognitive Control Assessed by Category Fluency | During the one day of cognitive assessment administration. | DKEFS Category Fluency scores were used to measure cognitive control of verbal ability, specifically measuring an individuals ability to access and retrieve semantic information (memory) as a component of executive function. Category fluency is scored by number of correct words plus errors in a 60 second trial in each of 3 categories. Wilcoxon rank-sum test was used to examine differences between groups. Normative scores for this assessment range 1-19 (mean of 10, and standard deviation of 3), and a higher score indicates superior cognitive control of verbal ability. |
| Verbal Ability Cognitive Flexibility, Assessed by Category Switching Scaled Score | During the one day of cognitive assessment administration. | DKEFS Category Switching scores will be used to measure cognitive control of verbal ability, specifically measuring an individuals ability to access and retrieve semantic information (memory), switching back and forth between 2 different semantic categories, a component of executive function. Category switching is scored by number of correct words plus errors. Wilcoxon rank-sum test was used to examine differences between groups. Normative scores for this assessment range 1-19 (mean of 10, and standard deviation of 3), and a higher score indicates superior cognitive control of verbal ability. |
| Assessment of Cognitive Flexibility Using Trails Scaled Score | During the one day of cognitive assessment administration. | Delis-Kaplan Executive Function System (DKEFS),Trail Making Task score was used to assess the cognitive flexibility component of executive function. Scores are derived from time to complete the task plus errors. Wilcoxon rank-sum test was used to examine differences between groups. Normative scores for this assessment range 1-19 (mean of 10, and standard deviation of 3), and a higher score indicates superior cognitive flexibility. |
| Lexical Processing Assessed by Letter Fluency, First Interval. | During one day of cognitive assessement administration. | DKEFS Letter Fluency, first interval scores will be used to measure cognitive control of lexical processing, specifically measuring an individuals ability to retrieve phonemic information, a component of executive function. Participants are asked to name as many words a they are able starting with a specific letter, without repetition. Wilcoxon rank-sum test was used to examine differences between groups. There are four intervals of this task the first assessing initiation of retrieval while the following trials measuring the ability to sustain retrieval. Normative scores for this assessment range 1-19 (mean of 10, and standard deviation of 3), and a higher score indicates superior cognitive control of lexical processing. |
| Lexical Processing as Assessed by Letter Fluency, Second Interval | During one day of cognitive assessement administration. | DKEFS Letter Fluency, second interval scores will be used to measure cognitive control of lexical processing, specifically measuring an individuals ability to retrieve phonemic information, a component of executive function. There are four intervals of this task the second through fourth trial assess ability to sustain retrieval. Participants are asked to name as many words a they are able starting with a specific letter, without repetition. Wilcoxon rank-sum test was used to examine differences between groups. Normative scores for this assessment range 1-19 (mean of 10, and standard deviation of 3), and a higher score indicates superior cognitive control of lexical processing. |
| Lexical Processing Assessed by Letter Fluency, Third Interval | During one day of cognitive assessment administration. | DKEFS Letter Fluency, third interval scores will be used to measure sustainment of cognitive control of lexical processing, specifically measuring an individuals ability to continue to retrieve phonemic information after multiple trials, a component of executive function. There are four intervals of this task the second through fourth trial assess ability to maintain retrieval. Participants are asked to name as many words a they are able starting with a specific letter, without repetition. Wilcoxon rank-sum test was used to examine differences between groups. Normative scores for this assessment range 1-19 (mean of 10, and standard deviation of 3), and a higher score indicates superior sustainment of cognitive control of lexical processing. |
| Lexical Processing Assessed by Letter Fluency, Fourth Interval | During one day of cognitive assessment administration. | DKEFS Letter Fluency, fourth interval scores will be used to measure sustainment of cognitive control of lexical processing, specifically measuring an individuals ability to continue to retrieve phonemic information after multiple trials, a component of executive function. There are four intervals of this task the second through fourth trial assess ability to maintain retrieval. Participants are asked to name as many words a they are able starting with a specific letter, without repetition. Wilcoxon rank-sum test was used to examine differences between groups. Normative scores for this assessment range 1-19 (mean of 10, and standard deviation of 3), and a higher score indicates superior sustainment of cognitive control of lexical processing. |
| Verbal Ability Cognitive Control of Inhibition, Assessed by Category Switching Accuracy Scaled Score | During the one day of cognitive assessment administration. | DKEFS Category Switching Accuracy scores will be used to measure cognitive control of verbal ability, specifically measuring an individuals ability to inhibit incorrect or repetitive semantic information (memory), while switching back and forth between 2 different semantic categories, a component of executive function. Wilcoxon rank-sum test was used to examine differences between groups. Normative scores for this assessment range 1-19 (mean of 10, and standard deviation of 3), and a higher score indicates superior cognitive control of verbal ability. |
| Assessment of Cognitive Flexibility Using Color-word Inference Test | During the one day of cognitive assessment administration. | DKEFS Color-Word Interference Test (CWIT) Inhibition Switching scores was used to measure the cognitive flexibility component of executive function. The CWIT is scored by time to complete plus errors. Wilcoxon rank-sum test was used to examine differences between groups. Normative scores for this assessment range 1-19 (mean of 10, and standard deviation of 3), and a higher score indicates superior cognitive flexibility. |
| Assessment of Inhibition Using Color-word Inference Test | During the one day of cognitive assessment administration. | DKEFS CWIT scores was used to measure the inhibition component of executive function. The CWIT is scored by time to complete plus errors. Wilcoxon rank-sum test was used to examine differences between groups. Normative scores for this assessment range 1-19 (mean of 10, and standard deviation of 3), and a higher score indicates superior inhibition. |
Countries
United States
Participant flow
Recruitment details
In August of 2020 recruitment began. Potential participants were recruited from the Joslin Diabetes Center hypoglycemia clinic, local advertisement, research match, and through participation in other studies. Recruitment ended August of 2021.
Pre-assignment details
There were plans to include controls (no history of gastric bypass, no hypoglycemia). 3 were recruited and assessed. Upon analysis they did not match age/BMI of the post-bariatric hypoglycemia (PBH) group, and with a low number, were excluded from the design. 3 additional participants were subsequently excluded upon review of history/records: 2 with no history of gastric bypass, and 1 with a traumatic brain injury (revealed upon detailed medical history).
Participants by arm
| Arm | Count |
|---|---|
| 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): Cognitive testing will assess premorbid intelligence, working memory and attention, verbal memory and delayed memory, executive function, and psychomotor speed.
ECG: ECG will take place during screening visit. | 7 |
| 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): Cognitive testing will assess premorbid intelligence, working memory and attention, verbal memory and delayed memory, executive function, and psychomotor speed.
ECG: ECG will take place during screening visit. | 7 |
| Total | 14 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Found to meet exclusionary criteria | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Hypoglycemia After Gastric Bypass Surgery - Post-bariatric Hypoglycemia (PBH) | Total | Post-gastric Bypass Participants Without a History of Hypoglycemia |
|---|---|---|---|
| Age, Continuous | 56 years STANDARD_DEVIATION 8 | 54.5 years STANDARD_DEVIATION 9.75 | 52 years STANDARD_DEVIATION 9 |
| Alcohol Use Disorders Identification Test (AUDIT-C) score | 0 Scores on a scale (range 0 to 10) STANDARD_DEVIATION 1.5 | 0.5 Scores on a scale (range 0 to 10) STANDARD_DEVIATION 1.5 | 1 Scores on a scale (range 0 to 10) STANDARD_DEVIATION 1.5 |
| Alcohol use (drinks per week) | 0 number of alcoholic drinks per week STANDARD_DEVIATION 0.25 | 0.115 number of alcoholic drinks per week STANDARD_DEVIATION 0.4625 | 0.25 number of alcoholic drinks per week STANDARD_DEVIATION 0.31 |
| Beck Depression Inventory score | 8 Scores on a scale (range is 0 to 63) STANDARD_DEVIATION 9.5 | 7.5 Scores on a scale (range is 0 to 63) STANDARD_DEVIATION 8.2 | 7 Scores on a scale (range is 0 to 63) STANDARD_DEVIATION 7 |
| Body composition fat percentage (%) | 41.5 percent STANDARD_DEVIATION 11.9 | 41.5 percent STANDARD_DEVIATION 10.5 | 41.5 percent STANDARD_DEVIATION 12.7 |
| Current body mass index (kg/m^2) | 31.4 kg/m^2 STANDARD_DEVIATION 5.4 | 31.5 kg/m^2 STANDARD_DEVIATION 9.575 | 32.9 kg/m^2 STANDARD_DEVIATION 11.3 |
| Duration of hypoglycemia (years) | 3 years STANDARD_DEVIATION 3.775 | 3 years STANDARD_DEVIATION 3.8 | 0 years STANDARD_DEVIATION 0 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants | 12 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Number of participants using recreational marijuana | 2 Participants | 2 Participants | 0 Participants |
| Number of participants with a smoking history | 2 Participants | 3 Participants | 1 Participants |
| Patient Health Questionnaire-2 (PHQ-2) score | 1 Scores on a scale (range 0 to 6) STANDARD_DEVIATION 2.5 | 0.5 Scores on a scale (range 0 to 6) STANDARD_DEVIATION 1.75 | 0 Scores on a scale (range 0 to 6) STANDARD_DEVIATION 0 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 7 Participants | 13 Participants | 6 Participants |
| Region of Enrollment United States | 7 participants | 14 participants | 7 participants |
| Sex: Female, Male Female | 7 Participants | 13 Participants | 6 Participants |
| Sex: Female, Male Male | 0 Participants | 1 Participants | 1 Participants |
| Years of education | 14 years STANDARD_DEVIATION 2 | 16 years STANDARD_DEVIATION 2 | 16 years STANDARD_DEVIATION 4 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 7 |
| other Total, other adverse events | 0 / 7 | 0 / 7 |
| serious Total, serious adverse events | 0 / 7 | 0 / 7 |
Outcome results
Primary
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.
Time frame: During the one day of cognitive assessment administration.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Hypoglycemia After Gastric Bypass Surgery - Post-bariatric Hypoglycemia (PBH) | Assessment of Delayed Verbal Memory | 9 RAVLT scores on a scale (range 0 to 15) | Standard Deviation 2 |
| Post-gastric Bypass Participants Without a History of Hypoglycemia | Assessment of Delayed Verbal Memory | 10 RAVLT scores on a scale (range 0 to 15) | Standard Deviation 1.5 |
p-value: 0.24Wilcoxon (Mann-Whitney)
Primary
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.
Time frame: During the one day of cognitive assessment administration.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Hypoglycemia After Gastric Bypass Surgery - Post-bariatric Hypoglycemia (PBH) | Assessment of Immediate Verbal Memory | 50 RAVLT scores on a scale (range 0 to 69) | Standard Deviation 6 |
| Post-gastric Bypass Participants Without a History of Hypoglycemia | Assessment of Immediate Verbal Memory | 48 RAVLT scores on a scale (range 0 to 69) | Standard Deviation 14.5 |
p-value: 0.9Wilcoxon (Mann-Whitney)
Primary
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.
Time frame: During the one day of cognitive assessment administration.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Hypoglycemia After Gastric Bypass Surgery - Post-bariatric Hypoglycemia (PBH) | Working Memory Assessed by the Letter Number Sequencing Scaled Score | 10 Scores on a scale (range 1 to 19) | Standard Deviation 2.5 |
| Post-gastric Bypass Participants Without a History of Hypoglycemia | Working Memory Assessed by the Letter Number Sequencing Scaled Score | 10 Scores on a scale (range 1 to 19) | Standard Deviation 1 |
p-value: 0.74Wilcoxon (Mann-Whitney)
Secondary
Assessment of Cognitive Flexibility Using Color-word Inference Test
DKEFS Color-Word Interference Test (CWIT) Inhibition Switching scores was used to measure the cognitive flexibility component of executive function. The CWIT is scored by time to complete plus errors. Wilcoxon rank-sum test was used to examine differences between groups. Normative scores for this assessment range 1-19 (mean of 10, and standard deviation of 3), and a higher score indicates superior cognitive flexibility.
Time frame: During the one day of cognitive assessment administration.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Hypoglycemia After Gastric Bypass Surgery - Post-bariatric Hypoglycemia (PBH) | Assessment of Cognitive Flexibility Using Color-word Inference Test | 11 Scores on a scale (range 1 to 19) | Standard Deviation 1.5 |
| Post-gastric Bypass Participants Without a History of Hypoglycemia | Assessment of Cognitive Flexibility Using Color-word Inference Test | 12 Scores on a scale (range 1 to 19) | Standard Deviation 3.5 |
p-value: 0.7Wilcoxon (Mann-Whitney)
Secondary
Assessment of Cognitive Flexibility Using Trails Scaled Score
Delis-Kaplan Executive Function System (DKEFS),Trail Making Task score was used to assess the cognitive flexibility component of executive function. Scores are derived from time to complete the task plus errors. Wilcoxon rank-sum test was used to examine differences between groups. Normative scores for this assessment range 1-19 (mean of 10, and standard deviation of 3), and a higher score indicates superior cognitive flexibility.
Time frame: During the one day of cognitive assessment administration.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Hypoglycemia After Gastric Bypass Surgery - Post-bariatric Hypoglycemia (PBH) | Assessment of Cognitive Flexibility Using Trails Scaled Score | 12 Scores on a scale (range 1 to 19) | Standard Deviation 2 |
| Post-gastric Bypass Participants Without a History of Hypoglycemia | Assessment of Cognitive Flexibility Using Trails Scaled Score | 11 Scores on a scale (range 1 to 19) | Standard Deviation 1.5 |
p-value: 0.51Wilcoxon (Mann-Whitney)
Secondary
Assessment of Inhibition Using Color-word Inference Test
DKEFS CWIT scores was used to measure the inhibition component of executive function. The CWIT is scored by time to complete plus errors. Wilcoxon rank-sum test was used to examine differences between groups. Normative scores for this assessment range 1-19 (mean of 10, and standard deviation of 3), and a higher score indicates superior inhibition.
Time frame: During the one day of cognitive assessment administration.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Hypoglycemia After Gastric Bypass Surgery - Post-bariatric Hypoglycemia (PBH) | Assessment of Inhibition Using Color-word Inference Test | 10 Scores on a scale (range 1 to 19) | Standard Deviation 2 |
| Post-gastric Bypass Participants Without a History of Hypoglycemia | Assessment of Inhibition Using Color-word Inference Test | 11 Scores on a scale (range 1 to 19) | Standard Deviation 4 |
p-value: 0.95Kruskal-Wallis
Secondary
Assessment of Psychomotor Speed
The grooved pegboard test is a manipulative dexterity task that assesses psychomotor speed, fine motor control, and rapid-visual motor coordination. Participants were asked to insert 25 grooved pegs into holes within the given time limit up to 300 seconds (the score upper limit is thus 300). Time taken to complete the test has been found to be inversely correlated with cognitive ability; therefore, a higher score represents an inferior score. Wilcoxon rank-sum test was used to examine differences between groups.
Time frame: During the one day of cognitive assessment administration.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Hypoglycemia After Gastric Bypass Surgery - Post-bariatric Hypoglycemia (PBH) | Assessment of Psychomotor Speed | 100 Seconds | Standard Deviation 10.5 |
| Post-gastric Bypass Participants Without a History of Hypoglycemia | Assessment of Psychomotor Speed | 102 Seconds | Standard Deviation 15 |
p-value: 0.85Wilcoxon (Mann-Whitney)
Secondary
Lexical Processing as Assessed by Letter Fluency, Second Interval
DKEFS Letter Fluency, second interval scores will be used to measure cognitive control of lexical processing, specifically measuring an individuals ability to retrieve phonemic information, a component of executive function. There are four intervals of this task the second through fourth trial assess ability to sustain retrieval. Participants are asked to name as many words a they are able starting with a specific letter, without repetition. Wilcoxon rank-sum test was used to examine differences between groups. Normative scores for this assessment range 1-19 (mean of 10, and standard deviation of 3), and a higher score indicates superior cognitive control of lexical processing.
Time frame: During one day of cognitive assessement administration.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Hypoglycemia After Gastric Bypass Surgery - Post-bariatric Hypoglycemia (PBH) | Lexical Processing as Assessed by Letter Fluency, Second Interval | 10 Scores on a scale (range 1 to 19) | Standard Deviation 5 |
| Post-gastric Bypass Participants Without a History of Hypoglycemia | Lexical Processing as Assessed by Letter Fluency, Second Interval | 11 Scores on a scale (range 1 to 19) | Standard Deviation 2 |
p-value: 0.3Wilcoxon (Mann-Whitney)
Secondary
Lexical Processing Assessed by Letter Fluency, First Interval.
DKEFS Letter Fluency, first interval scores will be used to measure cognitive control of lexical processing, specifically measuring an individuals ability to retrieve phonemic information, a component of executive function. Participants are asked to name as many words a they are able starting with a specific letter, without repetition. Wilcoxon rank-sum test was used to examine differences between groups. There are four intervals of this task the first assessing initiation of retrieval while the following trials measuring the ability to sustain retrieval. Normative scores for this assessment range 1-19 (mean of 10, and standard deviation of 3), and a higher score indicates superior cognitive control of lexical processing.
Time frame: During one day of cognitive assessement administration.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Hypoglycemia After Gastric Bypass Surgery - Post-bariatric Hypoglycemia (PBH) | Lexical Processing Assessed by Letter Fluency, First Interval. | 10 Scores on a scale (range 1 to 19) | Standard Deviation 3.5 |
| Post-gastric Bypass Participants Without a History of Hypoglycemia | Lexical Processing Assessed by Letter Fluency, First Interval. | 13 Scores on a scale (range 1 to 19) | Standard Deviation 3 |
p-value: 0.03Wilcoxon (Mann-Whitney)
Secondary
Lexical Processing Assessed by Letter Fluency, Fourth Interval
DKEFS Letter Fluency, fourth interval scores will be used to measure sustainment of cognitive control of lexical processing, specifically measuring an individuals ability to continue to retrieve phonemic information after multiple trials, a component of executive function. There are four intervals of this task the second through fourth trial assess ability to maintain retrieval. Participants are asked to name as many words a they are able starting with a specific letter, without repetition. Wilcoxon rank-sum test was used to examine differences between groups. Normative scores for this assessment range 1-19 (mean of 10, and standard deviation of 3), and a higher score indicates superior sustainment of cognitive control of lexical processing.
Time frame: During one day of cognitive assessment administration.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Hypoglycemia After Gastric Bypass Surgery - Post-bariatric Hypoglycemia (PBH) | Lexical Processing Assessed by Letter Fluency, Fourth Interval | 8 Scores on a scale (range 1 to 19) | Standard Deviation 6 |
| Post-gastric Bypass Participants Without a History of Hypoglycemia | Lexical Processing Assessed by Letter Fluency, Fourth Interval | 11 Scores on a scale (range 1 to 19) | Standard Deviation 1.5 |
p-value: 0.37Wilcoxon (Mann-Whitney)
Secondary
Lexical Processing Assessed by Letter Fluency, Third Interval
DKEFS Letter Fluency, third interval scores will be used to measure sustainment of cognitive control of lexical processing, specifically measuring an individuals ability to continue to retrieve phonemic information after multiple trials, a component of executive function. There are four intervals of this task the second through fourth trial assess ability to maintain retrieval. Participants are asked to name as many words a they are able starting with a specific letter, without repetition. Wilcoxon rank-sum test was used to examine differences between groups. Normative scores for this assessment range 1-19 (mean of 10, and standard deviation of 3), and a higher score indicates superior sustainment of cognitive control of lexical processing.
Time frame: During one day of cognitive assessment administration.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Hypoglycemia After Gastric Bypass Surgery - Post-bariatric Hypoglycemia (PBH) | Lexical Processing Assessed by Letter Fluency, Third Interval | 10 Scores on a scale (range 1 to 19) | Standard Deviation 1.5 |
| Post-gastric Bypass Participants Without a History of Hypoglycemia | Lexical Processing Assessed by Letter Fluency, Third Interval | 12 Scores on a scale (range 1 to 19) | Standard Deviation 2 |
p-value: 0.045Wilcoxon (Mann-Whitney)
Secondary
Verbal Ability Cognitive Control Assessed by Category Fluency
DKEFS Category Fluency scores were used to measure cognitive control of verbal ability, specifically measuring an individuals ability to access and retrieve semantic information (memory) as a component of executive function. Category fluency is scored by number of correct words plus errors in a 60 second trial in each of 3 categories. Wilcoxon rank-sum test was used to examine differences between groups. Normative scores for this assessment range 1-19 (mean of 10, and standard deviation of 3), and a higher score indicates superior cognitive control of verbal ability.
Time frame: During the one day of cognitive assessment administration.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Hypoglycemia After Gastric Bypass Surgery - Post-bariatric Hypoglycemia (PBH) | Verbal Ability Cognitive Control Assessed by Category Fluency | 10 Scores on a scale (range 1 to 19) | Standard Deviation 3 |
| Post-gastric Bypass Participants Without a History of Hypoglycemia | Verbal Ability Cognitive Control Assessed by Category Fluency | 14 Scores on a scale (range 1 to 19) | Standard Deviation 1 |
p-value: 0.01Wilcoxon (Mann-Whitney)
Secondary
Verbal Ability Cognitive Control Assessed by Letter Fluency
DKEFS Letter Fluency Task will be used to assess the verbal functioning cognitive control ability component of executive function. Scores are derived from the number of unique, correct words. Wilcoxon rank-sum test was used to examine differences between groups. Normative scores for this assessment range 1-19 (mean of 10, and standard deviation of 3), and a higher score indicates superior verbal functioning cognitive control ability.
Time frame: During the one day of cognitive assessment administration.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Hypoglycemia After Gastric Bypass Surgery - Post-bariatric Hypoglycemia (PBH) | Verbal Ability Cognitive Control Assessed by Letter Fluency | 8 Scores on a scale (range 1 to 19) | Standard Deviation 3.5 |
| Post-gastric Bypass Participants Without a History of Hypoglycemia | Verbal Ability Cognitive Control Assessed by Letter Fluency | 12 Scores on a scale (range 1 to 19) | Standard Deviation 2 |
p-value: 0.48Wilcoxon (Mann-Whitney)
Secondary
Verbal Ability Cognitive Control of Inhibition, Assessed by Category Switching Accuracy Scaled Score
DKEFS Category Switching Accuracy scores will be used to measure cognitive control of verbal ability, specifically measuring an individuals ability to inhibit incorrect or repetitive semantic information (memory), while switching back and forth between 2 different semantic categories, a component of executive function. Wilcoxon rank-sum test was used to examine differences between groups. Normative scores for this assessment range 1-19 (mean of 10, and standard deviation of 3), and a higher score indicates superior cognitive control of verbal ability.
Time frame: During the one day of cognitive assessment administration.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Hypoglycemia After Gastric Bypass Surgery - Post-bariatric Hypoglycemia (PBH) | Verbal Ability Cognitive Control of Inhibition, Assessed by Category Switching Accuracy Scaled Score | 10 Scores on a scale (range 1 to 19) | Standard Deviation 2 |
| Post-gastric Bypass Participants Without a History of Hypoglycemia | Verbal Ability Cognitive Control of Inhibition, Assessed by Category Switching Accuracy Scaled Score | 14 Scores on a scale (range 1 to 19) | Standard Deviation 3 |
p-value: 0.03Wilcoxon (Mann-Whitney)
Secondary
Verbal Ability Cognitive Flexibility, Assessed by Category Switching Scaled Score
DKEFS Category Switching scores will be used to measure cognitive control of verbal ability, specifically measuring an individuals ability to access and retrieve semantic information (memory), switching back and forth between 2 different semantic categories, a component of executive function. Category switching is scored by number of correct words plus errors. Wilcoxon rank-sum test was used to examine differences between groups. Normative scores for this assessment range 1-19 (mean of 10, and standard deviation of 3), and a higher score indicates superior cognitive control of verbal ability.
Time frame: During the one day of cognitive assessment administration.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Hypoglycemia After Gastric Bypass Surgery - Post-bariatric Hypoglycemia (PBH) | Verbal Ability Cognitive Flexibility, Assessed by Category Switching Scaled Score | 10 Scores on a scale (range 1 to 19) | Standard Deviation 2 |
| Post-gastric Bypass Participants Without a History of Hypoglycemia | Verbal Ability Cognitive Flexibility, Assessed by Category Switching Scaled Score | 15 Scores on a scale (range 1 to 19) | Standard Deviation 4.5 |
p-value: 0.01Wilcoxon (Mann-Whitney)