Status:
COMPLETED
Acetylcarnitine and Insulin Sensitivity
Lead Sponsor:
Mario Negri Institute for Pharmacological Research
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
40-65 years
Phase:
PHASE2
Brief Summary
Decreased insulin sensitivity (e.g. insulin resistance) is a hallmark and a major pathogenic factor of type 2 diabetes. It is the key factor of the metabolic syndrome - a cluster of arterial hypertens...
Detailed Description
Decreased insulin sensitivity (e.g. insulin resistance) is a hallmark and a major pathogenic factor of type 2 diabetes. Diabetes often is related to a cluster of arterial hypertension, obesity, impair...
Eligibility Criteria
Inclusion
- at least three of these
- Relatives with type 2 diabetes
- Age between 40 and 65 years
- Systolic and diastolic pressure ≥ 140 or ≥90 mmHg respectively
- Body mass index ≥25 for men and ≥24 for women
- Triglycerides ≥200 mg/dl
- Serum creatinine ≤1.5 mg/dl, proteinuria ≤ 0.5g/24h
- Capacity to understand the scope and the risks of the study
- written informed consent
Exclusion
- Concomitant treatment with steroids, anti-inflammatory and immunosuppressive drug, and any other drug acting on insulin sensitivity and/or insulin secretion, particularly glitazones and other oral hypoglycemic drug
- Treatment with L-acetylcarnitine in the six months before the study
- Previous or concomitant treatment with metformin
- legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible consequences of the trial.
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT00393770
Start Date
February 1 2004
End Date
September 1 2007
Last Update
June 10 2011
Active Locations (1)
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1
Clinical Research Center for Rare Diseases
Ranica, Bergamo, Italy, 24020