HypoglycemiaNCT04430582
Cognition in Patients With Hypoglycemia, Without Diabetes
An observational study of Hypoglycemia and Cognition, run by Joslin Diabetes Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hypoglycemia, Cognition
- What is being tested?
- Cognitive Assessment (not diagnostic) and ECG
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Aug 2020to 4 Aug 2021
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study - Cognition in Patients With Hypoglycemia, Without Diabetes
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.
Read the 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.
- Conditions
- Hypoglycemia, Cognition
- Being tested
- Cognitive Assessment (not diagnostic), ECG
- Keywords
- Executive Function, Memory, Post-Bariatric Hypoglycemia
- Medical subject headings
- Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
ECGDiagnostic test
Also called Electrocardiogram (ECG)
ECG will take place during screening visit.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Cognitive Assessment (not diagnostic); Diagnostic Test: ECG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: During the one day of cognitive assessment administration.
Secondary outcomes (12)
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.
Measured: During the one day of cognitive assessment administration.
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.
Measured: During the one day of cognitive assessment administration.
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.
Measured: During the one day of cognitive assessment administration.
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.
Measured: During the one day of cognitive assessment administration.
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.
Measured: During the one day of cognitive assessment administration.
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.
Measured: During the one day of cognitive assessment administration.
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.
Measured: During the one day of cognitive assessment administration.
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.
Measured: During the one day of cognitive assessment administration.
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.
Measured: During one day of cognitive assessement administration.
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.
Measured: During one day of cognitive assessement administration.
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.
Measured: During one day of cognitive assessment administration.
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.
Measured: During one day of cognitive assessment administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2020
- Study start4 Aug 2020
- Primary completion4 Aug 2021
- Study completion4 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypoglycemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joslin Diabetes Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mary Elizabeth Patti, MD, Principal investigator, Joslin Diabetes Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04430582
- Sponsor's protocol ID
- 00000098
- Status last verified
- Oct 2024
- First submitted
- 10 Jun 2020
- Last updated
- 4 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37667837
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study - Cognition in Patients With Hypoglycemia, Without Diabetes
- ClinicalTrials.gov ID
- NCT04430582
- Acronym / sponsor ID
- 00000098
- Conditions
- Hypoglycemia, Cognition
- Keywords
- Executive Function, Memory, Post-Bariatric Hypoglycemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Joslin Diabetes CenterUniversity, hospital or other
- Study start
- 4 Aug 2020 (actual)
- Primary completion
- 4 Aug 2021 (actual)
- Study completion
- 4 Aug 2021 (actual)
- First posted
- 12 Jun 2020 (actual)
- Results
- Posted 4 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypoglycemia after gastric bypass surgery - post-bariatric hypoglycemia (PBH) | – | Other: Cognitive Assessment (not diagnostic), Diagnostic Test: ECGParticipants with PBH, recruited from the Joslin Hypoglycemia Clinic and from other hypoglycemia studies at Joslin. |
| Post-gastric bypass participants without a history of hypoglycemia | – | Other: Cognitive Assessment (not diagnostic), Diagnostic Test: ECGParticipants 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Assessment (not diagnostic)Cognitive testing will assess premorbid intelligence, working memory and attention, verbal memory and delayed memory, executive function, and psychomotor speed. | Other | Hypoglycemia after gastric bypass surgery - post-bariatric hypoglycemia (PBH), Post-gastric bypass participants without a history of hypoglycemia |
| ECGAlso: Electrocardiogram (ECG)ECG will take place during screening visit. | Diagnostic test | Hypoglycemia after gastric bypass surgery - post-bariatric hypoglycemia (PBH), Post-gastric bypass participants without a history of hypoglycemia |
Primary outcome
Assessment of Immediate Verbal Memory
Time frame: 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
Time frame: 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
Time frame: 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.
12 secondary outcomes
Assessment of Cognitive Flexibility Using Trails Scaled Score
Time frame: During the one day of cognitive assessment administration.
Assessment of Cognitive Flexibility Using Color-word Inference Test
Time frame: During the one day of cognitive assessment administration.
Assessment of Inhibition Using Color-word Inference Test
Time frame: During the one day of cognitive assessment administration.
Verbal Ability Cognitive Control Assessed by Letter Fluency
Time frame: During the one day of cognitive assessment administration.
Assessment of Psychomotor Speed
Time frame: During the one day of cognitive assessment administration.
Verbal Ability Cognitive Control Assessed by Category Fluency
Time frame: During the one day of cognitive assessment administration.
Verbal Ability Cognitive Flexibility, Assessed by Category Switching Scaled Score
Time frame: During the one day of cognitive assessment administration.
Verbal Ability Cognitive Control of Inhibition, Assessed by Category Switching Accuracy Scaled Score
Time frame: During the one day of cognitive assessment administration.
Lexical Processing Assessed by Letter Fluency, First Interval.
Time frame: During one day of cognitive assessement administration.
Lexical Processing as Assessed by Letter Fluency, Second Interval
Time frame: During one day of cognitive assessement administration.
Lexical Processing Assessed by Letter Fluency, Third Interval
Time frame: During one day of cognitive assessment administration.
Lexical Processing Assessed by Letter Fluency, Fourth Interval
Time frame: During one day of cognitive assessment administration.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 37667837Puleio 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary Elizabeth Patti, MD principal investigator
Joslin Diabetes Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoglycemia and Cognition, run by Joslin Diabetes Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Immediate Verbal Memory (time frame: During the one day of cognitive assessment administration.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04430582, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2024.