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Sponsored by: |
Mario Negri Institute for Pharmacological Research |
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Information provided by: | Mario Negri Institute for Pharmacological Research |
ClinicalTrials.gov Identifier: | NCT00393770 |
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 hypertension, obesity, impaired glucose tolerance, dyslipidemia, coagulation abnormalities,albuminuria and increased cardiovascular risk – that may preceed or accompany type 2 diabetes. Insulin function and the abnormalities associated with insulin resistance, may have a major role in preventing type 2 diabetes and, in the long-term, diabetes micro- and macrovascular complications. Carnitine is involved in lipids and carbohydrates metabolism and acetyl-Lcarnitine(ALC), an intramitochondrial carrier of acylic group, may modulate cell fuel substrate utilization. Studies found that carnitine may improve insulin sensitivity and glucose disposal in healthy subjects and in patients with type 2 diabetes. A recent study also found that a primedconstant infusion of acetyl-L-carnitine (ALC) may increase glucose utilization in type 2 diabetic patients, possibly restoring the glycogen synthase activity.
Thus, we designed the Acetylcarnitine in insulin resistance study, a pilot, sequential,longitudinal study aimed to assess whether acetyl-carnitine may improve insulin function and lipid profile in patients at increased risk of type 2 diabetes.
Condition | Intervention | Phase |
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Type 2 Diabetes Mellitus |
Drug: L-acetylcarnitine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | A Pilot Study to Evaluate the Short-Term Effects of Acetil-Carnitine on Insulin Resistance and the Metabolic Syndrome in Patients at Increased Risk of Type 2 Diabetes: Acetyl-Carnitine in Insulin Resistance |
Estimated Enrollment: | 40 |
Study Start Date: | February 2004 |
Estimated Study Completion Date: | February 2007 |
Ages Eligible for Study: | 40 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
at least three of these
Exclusion Criteria:
Contact: Norberto Perico, MD | 003903545351 | perico@marionegri.it |
Italy, Bergamo | |
Clinical Research Center for Rare Diseases | Recruiting |
Ranica, Bergamo, Italy, 24020 | |
Contact: Norberto Perico, MD 003903545351 perico@marionegri.it |
Principal Investigator: | Norberto Perico, MD | Mario Negri Institute |
Study ID Numbers: | LAC01 |
Study First Received: | October 27, 2006 |
Last Updated: | October 27, 2006 |
ClinicalTrials.gov Identifier: | NCT00393770 History of Changes |
Health Authority: | Italy: Ministry of Health |
Risk of type 2 diabetes |
Nootropic Agents Vitamin B Complex Metabolic Diseases Diabetes Mellitus Endocrine System Diseases Trace Elements Insulin Hyperinsulinism Vitamins |
Diabetes Mellitus, Type 2 Micronutrients Insulin Resistance Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder Carnitine Acetylcarnitine |
Nootropic Agents Metabolic Diseases Vitamin B Complex Growth Substances Physiological Effects of Drugs Diabetes Mellitus Endocrine System Diseases Pharmacologic Actions Hyperinsulinism |
Vitamins Therapeutic Uses Diabetes Mellitus, Type 2 Micronutrients Insulin Resistance Glucose Metabolism Disorders Central Nervous System Agents Acetylcarnitine |