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Acetylcarnitine and Insulin Sensitivity

This study has been completed.
Sponsor:
Information provided by:
Mario Negri Institute for Pharmacological Research
ClinicalTrials.gov Identifier:
NCT00393770
First received: October 27, 2006
Last updated: June 9, 2011
Last verified: June 2011
History of Changes
  Purpose

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 Intervention Phase
Type 2 Diabetes Mellitus
 Drug: L-acetylcarnitine
 Phase 2

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mario Negri Institute for Pharmacological Research:

Primary Outcome Measures:
  • Insulin sensitivity [ Time Frame: At 0,3, 6 and 8 months. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Lipid profile. [ Time Frame: At 0,3, 6 and 8 months. ] [ Designated as safety issue: Yes ]

Enrollment: 43
Study Start Date: February 2004
Study Completion Date: September 2007
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: L-acetylcarnitine Drug: L-acetylcarnitine
250-500 mg/kg/die.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Mario Negri Institute for Pharmacological Research

Additional 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
Study First Received: October 27, 2006
Last Updated: June 9, 2011
Health Authority: Italy: Ministry of Health

Keywords provided by Mario Negri Institute for Pharmacological Research:
Risk of type 2 diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism
Acetylcarnitine
Nootropic Agents
 Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 21, 2013