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Acetylcarnitine and Insulin Sensitivity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00393770
Recruitment Status : Completed
First Posted : October 29, 2006
Last Update Posted : June 10, 2011
Information provided by:
Mario Negri Institute for Pharmacological Research

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 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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: L-acetylcarnitine Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : February 2004
Actual Primary Completion Date : October 2006
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: L-acetylcarnitine Drug: L-acetylcarnitine
250-500 mg/kg/die.

Primary Outcome Measures :
  1. Insulin sensitivity [ Time Frame: At 0,3, 6 and 8 months. ]

Secondary Outcome Measures :
  1. Lipid profile. [ Time Frame: At 0,3, 6 and 8 months. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00393770

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Clinical Research Center for Rare Diseases
Ranica, Bergamo, Italy, 24020
Sponsors and Collaborators
Mario Negri Institute for Pharmacological Research
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Principal Investigator: Norberto Perico, MD Mario Negri Institute
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Norberto Perico, Mario Negri Institute Identifier: NCT00393770    
Other Study ID Numbers: LAC01
First Posted: October 29, 2006    Key Record Dates
Last Update Posted: June 10, 2011
Last Verified: June 2011
Keywords provided by Mario Negri Institute for Pharmacological Research:
Risk of type 2 diabetes
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vitamin B Complex
Physiological Effects of Drugs
Nootropic Agents