Acetylcarnitine and Insulin Sensitivity
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 precede 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-L-carnitine(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 primed constant 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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Study to Evaluate the Short-term Effects of Acetyl-carnitine on Insulin Resistance and the Metabolic Syndrome in Patients at Increased Risk of Type 2 Diabetes: Acetyl-carnitine in Insulin Resistance|
- Insulin sensitivity [ Time Frame: At 0,3, 6 and 8 months. ] [ Designated as safety issue: Yes ]
- Lipid profile. [ Time Frame: At 0,3, 6 and 8 months. ] [ Designated as safety issue: Yes ]
|Study Start Date:||February 2004|
|Study Completion Date:||September 2007|
|Primary Completion Date:||October 2006 (Final data collection date for primary outcome measure)|
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT00393770
|Clinical Research Center for Rare Diseases|
|Ranica, Bergamo, Italy, 24020|
|Principal Investigator:||Norberto Perico, MD||Mario Negri Institute|