Cognition in Patients With Hypoglycemia, Without Diabetes
Pilot Study - Cognition in Patients With Hypoglycemia, Without Diabetes
Sponsor study identifier
observational
22
1 country
1
Study Start
August 4, 2020
Actual (reported)Primary Completion
August 4, 2021
Actual (reported)Study Completion
August 4, 2021
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 4, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 10, 2020
Actual (reported)June 12, 2020
Actual (reported)August 4, 2020
Actual (reported)August 4, 2021
Actual (reported)August 4, 2021
Actual (reported)November 4, 2024
Actual (reported)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.
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.
Participants with PBH, recruited from the Joslin Hypoglycemia Clinic and from other hypoglycemia studies at Joslin.
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 testing will assess premorbid intelligence, working memory and attention, verbal memory and delayed memory, executive function, and psychomotor speed.
ECG will take place during screening visit.
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.
Joslin Diabetes Center
Boston, Massachusetts, 02215, United States
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.
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.
Mary Elizabeth Patti, MD
Joslin Diabetes Center
22 participants (actual enrollment reported by the registry).
First Submitted
June 10, 2020
First Posted
June 12, 2020
Study Start
August 4, 2020
Actual (reported)Blood/Interstitial Glucose Measurements and Cognitive Function During Hypoglycemia and Recovery
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
August 4, 2021
Actual (reported)Study Completion
August 4, 2021
Actual (reported)Last Updated
November 4, 2024
Results First Posted
November 4, 2024
Record last verified: 2024-10
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Source: ClinicalTrials.gov.
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