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Participants with post-bariatric hypoglycemia for Low Blood Sugar

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 july 2023
Awards & highlights

Summary

This trial is investigating mechanisms behind post-bariatric hypoglycemia, a condition where people experience low blood sugar levels after surgery to lose weight. Participation will include wearing a glucose monitor and providing stool and blood samples.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~july 2023
This trial's timeline: 3 weeks for screening, Varies for treatment, and july 2023 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Analysis of microbiome differences in patients with PBH
Assessment of glucagon responsiveness during glucagon stimulation testing
Assessment of hormonal responses during glucagon stimulation testing
+2 more
Secondary outcome measures
Correlation between counterregulatory hormone response to experimental hypoglycemia and magnitude of hypoglycemia as determined by continuous glucose monitoring (CGM)
Correlation between hypoglycemia frequency (as determined by CGM) and counterregulatory hormones.
Correlation between hypoglycemia frequency (as determined by CGM) and microbiome
Other outcome measures
Safety Outcome - Hyper - and hypoglycemia during the study.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Participants with post-bariatric hypoglycemiaExperimental Treatment6 Interventions
Individuals with history of Roux-en-Y gastric bypass surgery, who have a history of hypoglycemia will be recruited from the Joslin Hypoglycemia Clinic.
Group II: Control groupExperimental Treatment6 Interventions
Individuals without a history of bariatric surgery will be recruited by local advertisement.
Group III: Asymptomatic participants with Roux-en-Y gastric bypass (RYGB)Experimental Treatment6 Interventions
Individuals with history of RYGB, without a history of or symptoms of hypoglycemia will be recruited from local postoperative surgical clinics and from the community.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Continuous Glucose Monitoring
2023
Completed Phase 2
~1000
activity monitor
2021
N/A
~20

Find a Location

Who is running the clinical trial?

Joslin Diabetes CenterLead Sponsor
97 Previous Clinical Trials
26,517 Total Patients Enrolled
University of MichiganOTHER
1,833 Previous Clinical Trials
6,423,023 Total Patients Enrolled
Mary Elizabeth Patti, MDPrincipal InvestigatorJoslin Diabetes Center
4 Previous Clinical Trials
179 Total Patients Enrolled
~19 spots leftby Sep 2025
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