Status:
COMPLETED
Oral Hypoglycemic Therapy for Monogenic Variant Carriers of the Joslin Medalist Study
Lead Sponsor:
Joslin Diabetes Center
Conditions:
Type 1 Diabetes
Monogenic Diabetes
Eligibility:
All Genders
Up to 85 years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to evaluate the efficacy of adding oral hypoglycemic agents (OHA) to existing insulin treatment in monogenic variant carriers of the Joslin 50-Year Medalist Study ("Medali...
Eligibility Criteria
Inclusion
- Existing participants in the Joslin 50-Year Medalist Study
- Residing in the United States
- Capable of giving informed consent
- Known detectable C-peptide \>0.05 ng/mL
Exclusion
- Known diagnosis of cancer or active inflammatory disease such as rheumatoid arthritis, lupus, and inflammatory bowel disease
- Recent history of myocardial infarction, angioplasty, bypass surgery, heart failure, angina, stroke, or uncontrolled hypertension\>160/100 during the past 3 months
- Known diagnosis of cognitive dysfunction, dementia or Alzheimer's disease
- Pre-existing liver disease or liver function tests (AST or ALT)\>3x the upper limit of normal
- Pre-existing kidney disease (Chronic Kidney Disease Stage IV and below, or estimated glomerular filtration rate\<45 mL/min/1.73 m2)
- Active use of immunosuppressants
- Recipients of prior islet cell or pancreas transplantation
- Inability to travel due to frailty or health reasons
- Donated blood within the previous two (2) months
Key Trial Info
Start Date :
August 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT04409795
Start Date
August 26 2021
End Date
December 31 2024
Last Update
February 24 2025
Active Locations (1)
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1
Joslin Diabetes Center
Boston, Massachusetts, United States, 02215