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Acetylcarnitine and Insulin Sensitivity

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ClinicalTrials.gov Identifier: NCT00393770
Recruitment Status : Completed
First Posted : October 30, 2006
Last Update Posted : June 10, 2011
Sponsor:
Information provided by:

Study Description
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 Design

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
Primary Completion Date : October 2006
Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

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. ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00393770


Locations
Italy
Clinical Research Center for Rare Diseases
Ranica, Bergamo, Italy, 24020
Sponsors and Collaborators
Mario Negri Institute for Pharmacological Research
Investigators
Principal Investigator: Norberto Perico, MD Mario Negri Institute
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Norberto Perico, Mario Negri Institute
ClinicalTrials.gov Identifier: NCT00393770     History of Changes
Other Study ID Numbers: LAC01
First Posted: October 30, 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:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Acetylcarnitine
Hypoglycemic Agents
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Nootropic Agents