| Trial ID: | L7041 |
| Source ID: | NCT01159847
|
| Associated Drug: |
Sitagliptin
|
| Title: |
Protective Effects of Sitagliptin on β Cell Function in Patients With Adult-onset Latent Autoimmune Diabetes (LADA)
|
| Acronym: |
DPP-ⅣLADA
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 1 Diabetes
|
| Interventions: |
DRUG: sitagliptin|DRUG: Insulin
|
| Outcome Measures: |
Primary: The effects of sitagliptin on β cell function and insulin sensitivity of LADA patients, 1. The assessment of the change of β cell function in patients with LADA treated with sitagliptin plus insulin by the standardized mixed meal stimulation test and insulin sensitivity by HOMA-IR. 2. The assessment of the change of insulin sensitivity in LADA patients by sequential insulin infusion with the euglycemic glucose clamp technique., 2 years | Secondary: The possible immunomodulatory effects of sitagliptin on LADA patients, The change of the frequency of pathogenic Teff (CD4+Th1, Th2, Th17 and CD8+) cells and CD4+CD25+Foxp3+Treg cells before and after sitagliptin treatment in LADA patients., 2 years|The possible immunomodulatory effects of sitagliptin on LADA patients, Effect of sitagliptin on cytokine production of Teff and Treg cells before and after sitagliptin treatment in LADA patients., 2 years|The possible immunomodulatory effects of sitagliptin on LADA patients, Effect of sitagliptin on Foxp3 mRNA expression of Treg cells and RORγT mRNA expression of Th17 cells before and after sitagliptin treatment in LADA patients., 2 years|The possible immunomodulatory effects of sitagliptin on LADA patients, The comparison of glutamic acid decarboxylase 65 (GAD65) reactive interferon-γ-Th1, IL-4-Th2, IL-17-Th17 and IL-10-Treg cells detected by enzyme-linked immunospot (ELISPOT) before and after sitagliptin treatment in LADA patients., 2 years|The possible immunomodulatory effects of sitagliptin on LADA patients, The change of the adiponectin, IL-6, IL-17 and CRP etc. before and after the sitagliptin treatment in LADA patients., 2 years
|
| Sponsor/Collaborators: |
Sponsor: European Foundation for the Study of Diabetes | Collaborators: Chinese Medical Association|Eli Lilly and Company
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1|PHASE2
|
| Enrollment: |
30
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2010-01
|
| Completion Date: |
2012-12
|
| Results First Posted: |
|
| Last Update Posted: |
2018-07-31
|
| Locations: |
Diabetes Center, Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University, Changsha, Hunan, 410011, China
|
| URL: |
https://clinicaltrials.gov/show/NCT01159847
|
