| Trial ID: | L5430 |
| Source ID: | NCT00917449
|
| Associated Drug: |
L-Arginine
|
| Title: |
Prevention of Type 2 Diabetes Mellitus by L-Arginine in Patients With Metabolic Syndrome
|
| Acronym: |
L-arginine
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Metabolic Syndrome|Impaired Glucose Tolerance|Insulin Resistance|Endothelial Dysfunction
|
| Interventions: |
DRUG: L-arginine|DRUG: Placebo
|
| Outcome Measures: |
Primary: To evaluate the efficacy of long term (18 months) L-Arginine therapy in preventing or delaying clinical onset of type 2 diabetes mellitus in subjects with impaired glucose tolerance (IGT) and Metabolic Syndrome., 18 months | Secondary: Define if the treatment with L-arginine can ameliorate insulin sensitivity and endothelial dysfunction and find new risk profiles and candidate genes able to characterize the sub-group of patients at higher risk to develop type 2 diabetes mellitus., 18 months
|
| Sponsor/Collaborators: |
Sponsor: IRCCS San Raffaele
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
142
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: PREVENTION
|
| Start Date: |
2005-12
|
| Completion Date: |
2009-06
|
| Results First Posted: |
|
| Last Update Posted: |
2009-06-10
|
| Locations: |
Scientific Institute San Raffaele, Milan, 20132, Italy
|
| URL: |
https://clinicaltrials.gov/show/NCT00917449
|
