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Endoplasmic Reticulum Stress Relieving Agent
Tauroursodeoxycholic Acid (TUDCA) in New-Onset Type 1 Diabetes
Phase 2
Waitlist Available
Led By Rudolph Leibel, MD
Research Sponsored by Robin Goland, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights
All Individual Drugs Already Approved
Summary
This trial tests TUDCA, a medication that reduces cell stress, on patients with type 1 diabetes. The aim is to help insulin-producing cells survive and function better, potentially slowing down or preventing the disease's progression.
Eligible Conditions
- Type 1 Diabetes
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
C-peptide measurement as reflection of insulin secretion
Secondary study objectives
Endoplasmic reticulum stress
liver function tests
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Taurourodeoxycholic Acid (TUDCA)Experimental Treatment1 Intervention
TUDCA 1750 mg/day x 12 months
Group II: Sugar pill (placebo)Placebo Group1 Intervention
Placebo at same dose, frequency, and duration as experimental treatment
Find a Location
Who is running the clinical trial?
Juvenile Diabetes Research FoundationOTHER
235 Previous Clinical Trials
142,421 Total Patients Enrolled
Robin Goland, MDLead Sponsor
Rudolph Leibel, MDPrincipal InvestigatorColumbia University