Acetylcarnitine and Insulin Sensitivity

• Status: Completed
• Trial end date: 2007-09-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mario Negri Institute for Pharmacological Research
• Treatments: Acetylcarnitine; Insulin

Criteria

Inclusion Criteria:

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 Criteria:

• 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.