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Acetylcarnitine and Insulin Sensitivity
This study is currently recruiting participants.
Verified by Mario Negri Institute for Pharmacological Research, October 2006
First Received: October 27, 2006   No Changes Posted
Sponsored by: Mario Negri Institute for Pharmacological Research
Information provided by: Mario Negri Institute for Pharmacological Research
ClinicalTrials.gov Identifier: NCT00393770
  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 preceed 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-Lcarnitine(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 primedconstant 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 II

MedlinePlus related topics: Diabetes
Drug Information available for: Insulin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title: A Pilot Study to Evaluate the Short-Term Effects of Acetil-Carnitine on Insulin Resistance and the Metabolic Syndrome in Patients at Increased Risk of Type 2 Diabetes: Acetyl-Carnitine in Insulin Resistance

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

Primary Outcome Measures:
  • Insulin sensitivity
  • Lipid profile

Estimated Enrollment: 40
Study Start Date: February 2004
Estimated Study Completion Date: February 2007
  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
  • Sistolic and diastolic pressure ≥ 140 or ≥90 mmHg respectively
  • Body mass index ≥25 for men and ≥24 for women
  • Tryglicerides ≥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 metformine
  • 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

Contacts
Contact: Norberto Perico, MD 003903545351 perico@marionegri.it

Locations
Italy, Bergamo
Clinical Research Center for Rare Diseases Recruiting
Ranica, Bergamo, Italy, 24020
Contact: Norberto Perico, MD     003903545351     perico@marionegri.it    
Sponsors and Collaborators
Mario Negri Institute for Pharmacological Research
Investigators
Principal Investigator: Norberto Perico, MD Mario Negri Institute
  More Information

No publications provided

Study ID Numbers: LAC01
Study First Received: October 27, 2006
Last Updated: October 27, 2006
ClinicalTrials.gov Identifier: NCT00393770     History of Changes
Health Authority: Italy: Ministry of Health

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

Study placed in the following topic categories:
Nootropic Agents
Vitamin B Complex
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Trace Elements
Insulin
Hyperinsulinism
Vitamins
Diabetes Mellitus, Type 2
Micronutrients
Insulin Resistance
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder
Carnitine
Acetylcarnitine

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

ClinicalTrials.gov processed this record on May 07, 2009