| Trial ID: | L3784 |
| Source ID: | NCT00645840
|
| Associated Drug: |
Anakinra
|
| Title: |
Anti-inflammatory Therapy With Anakinra in Newly Diagnosed Type 1 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00645840/results
|
| Conditions: |
Type 1 Diabetes Mellitus
|
| Interventions: |
DRUG: Anakinra
|
| Outcome Measures: |
Primary: Effect of Anakinra Treatment on PBMC Gene Expression for Patients, Expression data at baseline and after treatment were available on 10 patients who had received anakinra. These were compared to similarly-timed samples from 10 patients from control group B. Several attempts have been made to contact the PI to verify information, but were unsuccessful. Unable to verify if 10 or 12 patients were analyzed., 1 month | Secondary: C-peptide Secretory Capacity, Mixed-meal tolerance tests. MMTTs were conducted at the UT Southwestern Clinical Translational Research Center (CTRC). Subjects underwent MMTTs at 3-4 wk after diagnosis and again at 7 months after diagnosis. C-peptide analyses were performed by Dr Philip Raskin (UTSouthwestern MedicalCenter, Dallas, TX,USA). C-peptide AUC was calculated for each MMTT using the trapezoidal method. C-peptide AUC data between groups were rank transformed and then analyzed using a two-way repeated measures analysis of variance (ANOVA)., 7 months
|
| Sponsor/Collaborators: |
Sponsor: University of Texas Southwestern Medical Center | Collaborators: Children's Medical Center Dallas
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT
|
| Phases: |
PHASE1|PHASE2
|
| Enrollment: |
15
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2008-03
|
| Completion Date: |
2009-09
|
| Results First Posted: |
2019-11-14
|
| Last Update Posted: |
2019-11-14
|
| Locations: |
Children's Medical Center, Dallas, Texas, 75235, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00645840
|
