| Trial ID: | L5032 |
| Source ID: | NCT01334684
|
| Associated Drug: |
Metformin
|
| Title: |
Gene Expression Profiles and Metformin Efficacy in Type 2 Diabetes
|
| Acronym: |
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes
|
| Interventions: |
DRUG: Metformin
|
| Outcome Measures: |
Primary: Fasting glucose change after metformin treatment in respect to mRNA and miRNA expression profiles in white blood cells, Changes in fasting glucose levels will be used to evaluate if metformin monotherapy efficacy in type 2 diabetic patients is predicted by mRNA and/or miRNA expression profiles. Please note that metformin major effect is to decrease hepatic glucose output and, therefore, to lower fasting plasma glucose which is, in fact, the clinical outcome used in this study. Finally, because of a very short wash-out period (i.e. 5 days) we will not be able to use HbA1c which will be inevitably conditioned by previous oral hypoglicemic therapy., Baseline and after three months of metfomin therapy | Secondary: Change in fasting insulin levels after metformin treatment in respect to mRNA and miRNA expression profiles in white blood cells, Baseline and after three months of metfomin therapy
|
| Sponsor/Collaborators: |
Sponsor: Casa Sollievo della Sofferenza IRCCS | Collaborators: University Hospital, Catania
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
100
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2011-05
|
| Completion Date: |
2013-09
|
| Results First Posted: |
|
| Last Update Posted: |
2011-04-13
|
| Locations: |
Casa Sollievo Della Sofferenza IRCCS, San Giovanni Rotondo, Foggia, 71013, Italy
|
| URL: |
https://clinicaltrials.gov/show/NCT01334684
|
