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Hypoglycemia, no upper gastrointestinal (GI) surgery 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 march 2020 through march 2025
Awards & highlights

Summary

This trial will help researchers understand what causes low blood sugar in people without diabetes, and whether there are any genetic or microbiome differences that contribute to this condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~march 2020 through march 2025
This trial's timeline: 3 weeks for screening, Varies for treatment, and march 2020 through 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
Analysis of glucose patterns during masked continuous glucose monitoring (CGM), including time in range, time in hypoglycemia, time in hyperglycemia, comparing the study groups.
Analysis of hormonal responses during mixed meal testing.
Analysis of metabolic responses during mixed meal testing.
+7 more
Secondary outcome measures
Relationship between hormonal responses and magnitude of hypoglycemia as determined by CGM.
Relationship between hormonal responses and microbiome.
Relationship between metabolic responses and magnitude of hypoglycemia as determined by CGM.
+1 more
Other outcome measures
Safety outcome- hyperglycemia and hypoglycemia during the study

Trial Design

3Treatment groups
Experimental Treatment
Group I: Hypoglycemia, with history of upper GI surgeryExperimental Treatment6 Interventions
Males or females with hypoglycemia with neuroglycopenia, with history of upper GI surgery
Group II: Hypoglycemia, no upper gastrointestinal (GI) surgeryExperimental Treatment6 Interventions
Males or females with hypoglycemia with neuroglycopenia, but no history of upper GI surgery, diabetes or prediabetes
Group III: Controls, without hypoglycemia or upper GI surgeryExperimental Treatment6 Interventions
Males or females with no history of upper gastrointestinal surgery, hypoglycemia, or diabetes.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
activity monitor
2021
N/A
~20
Continuous glucose monitoring
2019
N/A
~610

Find a Location

Who is running the clinical trial?

Joslin Diabetes CenterLead Sponsor
97 Previous Clinical Trials
26,589 Total Patients Enrolled
Mary Elizabeth Patti, MDPrincipal InvestigatorJoslin Diabetes Center
4 Previous Clinical Trials
251 Total Patients Enrolled
~6 spots leftby Sep 2025
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