| Trial ID: | L6134 |
| Source ID: | NCT02218619
|
| Associated Drug: |
Tauroursodeoxycholic Acid (Tudca)
|
| Title: |
Tauroursodeoxycholic Acid (TUDCA) in New-Onset Type 1 Diabetes
|
| Acronym: |
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 1 Diabetes
|
| Interventions: |
DRUG: Tauroursodeoxycholic Acid (TUDCA)|DRUG: Sugar Pill (placebo)
|
| Outcome Measures: |
Primary: C-peptide measurement as reflection of insulin secretion, The primary endpoint will be the area under the stimulated C-peptide curve over the first 2 hours of a 4- hour mixed meal tolerance test conducted at screening, and during the 12 months of drug treatment at 6 and12 months and at 6 months after drug or placebo is stopped., 18 months | Secondary: Endoplasmic reticulum stress, It is believed that the autoimmune assault of new onset type 1 diabetes leads to stress to the part of the beta cell that folds proteins; referred to as endoplasmic reticulum stress. When endoplasmic reticulum stress increases, changes in protein levels in beta cells occur. We will measure markers of endoplasmic reticulum stress in beta cells taken from skin biopsies taken from subjects before treatment with TUDCA or placebo., 1 week|liver function tests, We will measure liver function tests at 6 and 12 months and at 6 months after drug or placebo is stopped to ensure that no abnormalities of liver function occur with the drug., 18 months
|
| Sponsor/Collaborators: |
Sponsor: Robin Goland, MD | Collaborators: Juvenile Diabetes Research Foundation
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
20
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2015-08
|
| Completion Date: |
2019-10-01
|
| Results First Posted: |
|
| Last Update Posted: |
2018-12-04
|
| Locations: |
Naomi Berrie Diabetes Center, Columbia University, 1150 St. Nicholas Ave., New York, New York, 10032, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT02218619
|
