Trial Outcomes & Findings for Cognition in Patients With Hypoglycemia, Without Diabetes (NCT NCT04430582)
NCT ID: NCT04430582
Last Updated: 2024-11-04
Results Overview
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.
COMPLETED
22 participants
During the one day of cognitive assessment administration.
2024-11-04
Participant Flow
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.
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).
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
|
Overall Study
COMPLETED
|
7
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Found to meet exclusionary criteria
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Cognition in Patients With Hypoglycemia, Without Diabetes
Baseline characteristics by cohort
| Measure |
Hypoglycemia After Gastric Bypass Surgery - Post-bariatric Hypoglycemia (PBH)
n=7 Participants
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.
|
Post-gastric Bypass Participants Without a History of Hypoglycemia
n=7 Participants
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.
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56 years
STANDARD_DEVIATION 8 • n=5 Participants
|
52 years
STANDARD_DEVIATION 9 • n=7 Participants
|
54.5 years
STANDARD_DEVIATION 9.75 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
7 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Current body mass index (kg/m^2)
|
31.4 kg/m^2
STANDARD_DEVIATION 5.4 • n=5 Participants
|
32.9 kg/m^2
STANDARD_DEVIATION 11.3 • n=7 Participants
|
31.5 kg/m^2
STANDARD_DEVIATION 9.575 • n=5 Participants
|
|
Body composition fat percentage (%)
|
41.5 percent
STANDARD_DEVIATION 11.9 • n=5 Participants
|
41.5 percent
STANDARD_DEVIATION 12.7 • n=7 Participants
|
41.5 percent
STANDARD_DEVIATION 10.5 • n=5 Participants
|
|
Patient Health Questionnaire-2 (PHQ-2) score
|
1 Scores on a scale (range 0 to 6)
STANDARD_DEVIATION 2.5 • n=5 Participants
|
0 Scores on a scale (range 0 to 6)
STANDARD_DEVIATION 0 • n=7 Participants
|
0.5 Scores on a scale (range 0 to 6)
STANDARD_DEVIATION 1.75 • n=5 Participants
|
|
Beck Depression Inventory score
|
8 Scores on a scale (range is 0 to 63)
STANDARD_DEVIATION 9.5 • n=5 Participants
|
7 Scores on a scale (range is 0 to 63)
STANDARD_DEVIATION 7 • n=7 Participants
|
7.5 Scores on a scale (range is 0 to 63)
STANDARD_DEVIATION 8.2 • n=5 Participants
|
|
Alcohol Use Disorders Identification Test (AUDIT-C) score
|
0 Scores on a scale (range 0 to 10)
STANDARD_DEVIATION 1.5 • n=5 Participants
|
1 Scores on a scale (range 0 to 10)
STANDARD_DEVIATION 1.5 • n=7 Participants
|
0.5 Scores on a scale (range 0 to 10)
STANDARD_DEVIATION 1.5 • n=5 Participants
|
|
Alcohol use (drinks per week)
|
0 number of alcoholic drinks per week
STANDARD_DEVIATION 0.25 • n=5 Participants
|
0.25 number of alcoholic drinks per week
STANDARD_DEVIATION 0.31 • n=7 Participants
|
0.115 number of alcoholic drinks per week
STANDARD_DEVIATION 0.4625 • n=5 Participants
|
|
Number of participants with a smoking history
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Number of participants using recreational marijuana
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Years of education
|
14 years
STANDARD_DEVIATION 2 • n=5 Participants
|
16 years
STANDARD_DEVIATION 4 • n=7 Participants
|
16 years
STANDARD_DEVIATION 2 • n=5 Participants
|
|
Duration of hypoglycemia (years)
|
3 years
STANDARD_DEVIATION 3.775 • n=5 Participants
|
0 years
STANDARD_DEVIATION 0 • n=7 Participants
|
3 years
STANDARD_DEVIATION 3.8 • n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Hypoglycemia After Gastric Bypass Surgery - Post-bariatric Hypoglycemia (PBH)
n=7 Participants
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.
|
Post-gastric Bypass Participants Without a History of Hypoglycemia
n=7 Participants
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.
|
|---|---|---|
|
Assessment of Immediate Verbal Memory
|
50 RAVLT scores on a scale (range 0 to 69)
Standard Deviation 6
|
48 RAVLT scores on a scale (range 0 to 69)
Standard Deviation 14.5
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Hypoglycemia After Gastric Bypass Surgery - Post-bariatric Hypoglycemia (PBH)
n=7 Participants
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.
|
Post-gastric Bypass Participants Without a History of Hypoglycemia
n=7 Participants
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.
|
|---|---|---|
|
Assessment of Delayed Verbal Memory
|
9 RAVLT scores on a scale (range 0 to 15)
Standard Deviation 2
|
10 RAVLT scores on a scale (range 0 to 15)
Standard Deviation 1.5
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Hypoglycemia After Gastric Bypass Surgery - Post-bariatric Hypoglycemia (PBH)
n=7 Participants
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.
|
Post-gastric Bypass Participants Without a History of Hypoglycemia
n=7 Participants
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.
|
|---|---|---|
|
Working Memory Assessed by the Letter Number Sequencing Scaled Score
|
10 Scores on a scale (range 1 to 19)
Standard Deviation 2.5
|
10 Scores on a scale (range 1 to 19)
Standard Deviation 1
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Hypoglycemia After Gastric Bypass Surgery - Post-bariatric Hypoglycemia (PBH)
n=7 Participants
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.
|
Post-gastric Bypass Participants Without a History of Hypoglycemia
n=7 Participants
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.
|
|---|---|---|
|
Assessment of Cognitive Flexibility Using Trails Scaled Score
|
12 Scores on a scale (range 1 to 19)
Standard Deviation 2
|
11 Scores on a scale (range 1 to 19)
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Hypoglycemia After Gastric Bypass Surgery - Post-bariatric Hypoglycemia (PBH)
n=7 Participants
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.
|
Post-gastric Bypass Participants Without a History of Hypoglycemia
n=7 Participants
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.
|
|---|---|---|
|
Assessment of Cognitive Flexibility Using Color-word Inference Test
|
11 Scores on a scale (range 1 to 19)
Standard Deviation 1.5
|
12 Scores on a scale (range 1 to 19)
Standard Deviation 3.5
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Hypoglycemia After Gastric Bypass Surgery - Post-bariatric Hypoglycemia (PBH)
n=7 Participants
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.
|
Post-gastric Bypass Participants Without a History of Hypoglycemia
n=7 Participants
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.
|
|---|---|---|
|
Assessment of Inhibition Using Color-word Inference Test
|
10 Scores on a scale (range 1 to 19)
Standard Deviation 2
|
11 Scores on a scale (range 1 to 19)
Standard Deviation 4
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Hypoglycemia After Gastric Bypass Surgery - Post-bariatric Hypoglycemia (PBH)
n=7 Participants
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.
|
Post-gastric Bypass Participants Without a History of Hypoglycemia
n=7 Participants
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.
|
|---|---|---|
|
Verbal Ability Cognitive Control Assessed by Letter Fluency
|
8 Scores on a scale (range 1 to 19)
Standard Deviation 3.5
|
12 Scores on a scale (range 1 to 19)
Standard Deviation 2
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Hypoglycemia After Gastric Bypass Surgery - Post-bariatric Hypoglycemia (PBH)
n=7 Participants
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.
|
Post-gastric Bypass Participants Without a History of Hypoglycemia
n=7 Participants
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.
|
|---|---|---|
|
Assessment of Psychomotor Speed
|
100 Seconds
Standard Deviation 10.5
|
102 Seconds
Standard Deviation 15
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Hypoglycemia After Gastric Bypass Surgery - Post-bariatric Hypoglycemia (PBH)
n=7 Participants
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.
|
Post-gastric Bypass Participants Without a History of Hypoglycemia
n=7 Participants
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.
|
|---|---|---|
|
Verbal Ability Cognitive Control Assessed by Category Fluency
|
10 Scores on a scale (range 1 to 19)
Standard Deviation 3
|
14 Scores on a scale (range 1 to 19)
Standard Deviation 1
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Hypoglycemia After Gastric Bypass Surgery - Post-bariatric Hypoglycemia (PBH)
n=7 Participants
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.
|
Post-gastric Bypass Participants Without a History of Hypoglycemia
n=7 Participants
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.
|
|---|---|---|
|
Verbal Ability Cognitive Flexibility, Assessed by Category Switching Scaled Score
|
10 Scores on a scale (range 1 to 19)
Standard Deviation 2
|
15 Scores on a scale (range 1 to 19)
Standard Deviation 4.5
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Hypoglycemia After Gastric Bypass Surgery - Post-bariatric Hypoglycemia (PBH)
n=7 Participants
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.
|
Post-gastric Bypass Participants Without a History of Hypoglycemia
n=7 Participants
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.
|
|---|---|---|
|
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
|
14 Scores on a scale (range 1 to 19)
Standard Deviation 3
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Hypoglycemia After Gastric Bypass Surgery - Post-bariatric Hypoglycemia (PBH)
n=7 Participants
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.
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Post-gastric Bypass Participants Without a History of Hypoglycemia
n=7 Participants
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.
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Lexical Processing Assessed by Letter Fluency, First Interval.
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10 Scores on a scale (range 1 to 19)
Standard Deviation 3.5
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13 Scores on a scale (range 1 to 19)
Standard Deviation 3
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SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Hypoglycemia After Gastric Bypass Surgery - Post-bariatric Hypoglycemia (PBH)
n=7 Participants
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.
|
Post-gastric Bypass Participants Without a History of Hypoglycemia
n=7 Participants
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.
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|---|---|---|
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Lexical Processing as Assessed by Letter Fluency, Second Interval
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10 Scores on a scale (range 1 to 19)
Standard Deviation 5
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11 Scores on a scale (range 1 to 19)
Standard Deviation 2
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SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Hypoglycemia After Gastric Bypass Surgery - Post-bariatric Hypoglycemia (PBH)
n=7 Participants
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.
|
Post-gastric Bypass Participants Without a History of Hypoglycemia
n=7 Participants
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.
|
|---|---|---|
|
Lexical Processing Assessed by Letter Fluency, Third Interval
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10 Scores on a scale (range 1 to 19)
Standard Deviation 1.5
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12 Scores on a scale (range 1 to 19)
Standard Deviation 2
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SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Hypoglycemia After Gastric Bypass Surgery - Post-bariatric Hypoglycemia (PBH)
n=7 Participants
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.
|
Post-gastric Bypass Participants Without a History of Hypoglycemia
n=7 Participants
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.
|
|---|---|---|
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Lexical Processing Assessed by Letter Fluency, Fourth Interval
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8 Scores on a scale (range 1 to 19)
Standard Deviation 6
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11 Scores on a scale (range 1 to 19)
Standard Deviation 1.5
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Adverse Events
Hypoglycemia After Gastric Bypass Surgery - Post-bariatric Hypoglycemia (PBH)
Post-gastric Bypass Participants Without a History of Hypoglycemia
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place