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Asymptomatic post-bariatric participants for Cognition

N/A
Waitlist Available
Led By Mary Elizabeth Patti, MD
Research Sponsored by Joslin Diabetes Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up march 2025
Awards & highlights

Summary

The purpose of this study is to determine if there is a relationship between recurrent hypoglycemia (low blood sugar) and cognition (thinking) in individuals who have a history of hypoglycemia, but do not have pre-diabetes or diabetes. This study will analyze whether recurrent hypoglycemia is associated with differences in cognition (thinking), and if individuals with a history of hypoglycemia perform less well on cognitive assessments compared to individuals without known hypoglycemia.

Eligible Conditions
  • Cognition
  • Low Blood Sugar

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~march 2025
This trial's timeline: 3 weeks for screening, Varies for treatment, and march 2025 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Assessment of delayed memory
Assessment of verbal memory
Assessment of working memory
Secondary outcome measures
Word Association Tests
Assessment of cognitive flexibility using trail making tasks
Assessment of inhibition
+3 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Hypoglycemia no upper GI surgery & no diabetes (DM) or pre-DMExperimental Treatment2 Interventions
Participants with hypoglycemia and no history of upper gastrointestinal surgery, and NO current diagnosis of diabetes or pre-diabetes, recruited from the Joslin Hypoglycemia Clinic, or from other hypoglycemia studies at Joslin.
Group II: Hypoglycemia after upper gastrointestinal (GI) surgeryExperimental Treatment2 Interventions
Participants with hypoglycemia after upper GI surgery, recruited from the Joslin Hypoglycemia Clinic and from other hypoglycemia studies at Joslin.
Group III: Controls, no hypoglycemia or history of upper GI surgeryExperimental Treatment2 Interventions
Participants without hypoglycemia or upper gastrointestinal surgery (controls), recruited by local advertisement. Some participants may be recruited from other hypoglycemia studies at Joslin.
Group IV: Asymptomatic post-bariatric participantsExperimental Treatment2 Interventions
Participants with a history of bariatric surgery, but without a diagnosis of hypoglycemia, or symptoms of hypoglycemia. They will be recruited by advertisement flyers at postoperative surgical clinics at local hospitals (e.g. Brigham and Women's and Beth Israel Deaconess Hospitals) and from other hypoglycemia studies at Joslin.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ECG
2016
Completed Phase 4
~33950

Find a Location

Who is running the clinical trial?

Joslin Diabetes CenterLead Sponsor
97 Previous Clinical Trials
26,542 Total Patients Enrolled
Mary Elizabeth Patti, MDPrincipal InvestigatorJoslin Diabetes Center
4 Previous Clinical Trials
204 Total Patients Enrolled
~16 spots leftby Sep 2025
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