Status:
COMPLETED
Prevention of Type 2 Diabetes Mellitus by L-Arginine in Patients With Metabolic Syndrome
Lead Sponsor:
IRCCS San Raffaele
Conditions:
Metabolic Syndrome
Impaired Glucose Tolerance
Eligibility:
All Genders
35+ years
Phase:
PHASE3
Brief Summary
Aim The principal objective of this project is: • To evaluate the efficacy of long term (18 months) L-Arginine therapy in preventing or delaying clinical onset of type 2 diabetes mellitus in subject...
Detailed Description
This is a double blind, parallel, one centre study to determine if long term oral L-arginine administration is able to delay or prevent type 2 diabetes mellitus in patients with IGT and Metabolic Synd...
Eligibility Criteria
Inclusion
- Written informed consent must be obtained before any procedure of the study is done.
- Male or Female aged more than 35 years.
- Diagnosis of IGT after a standard Glucose Tolerance Test (OGTT, 75 g)
- Moreover, in order to be considered affected by Metabolic Syndrome, they must have two or more of the following criteria:
- Abdominal obesity (waist\>120 cm for man, \>88 cm for women)
- Hypertriglyceridemia (\>150 mg/dl)
- Low HDL cholesterol (\<40mg/dl in man, \<50 mg/dl in woman)
- Hypertension (\>130 / \>85 mmHg)
Exclusion
- Presence of type 1 or type 2 diabetes mellitus
- Fasting glucose levels \>126 mg/dl
- Sitting Systolic Arterial Pressure \>140mmHg, and Sitting Diastolic Arterial Pressure \>90mmHg
- Pregnancy
- Known renal insufficiency or creatinine levels more than 1.8 mg/dl,
- Presence of chronic hepatopathy or levels of ALT and AST more than two standard deviations from normality levels
- Presence of malignancy
- Abuse of alcohol or abuse substances
- Psychiatric disorders
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
142 Patients enrolled
Trial Details
Trial ID
NCT00917449
Start Date
December 1 2005
End Date
June 1 2009
Last Update
June 10 2009
Active Locations (1)
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1
Scientific Institute San Raffaele
Milan, Milan, Italy, 20132