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Cardiac Autonomic Neuropathy in Patients With Metabolic Syndrome (CAN)

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: NCT00907127
Recruitment Status : Completed
First Posted : May 22, 2009
Last Update Posted : December 17, 2013
American Diabetes Association
Information provided by (Responsible Party):
Rodica Pop-Busui, University of Michigan

Brief Summary:
The study will test whether damage of the heart nerves appears in patients before they develop diabetes.

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Behavioral: Exercise and Diet (Metabolic Fitness Program) Phase 1

Detailed Description:
Patients who have mild abnormalities of blood sugar, high blood pressure, abnormal lipids and/or obesity can have a condition called metabolic syndrome. These patients are at high risk for diabetes and Cardiac Autonomic Neuropathy (CAN). Subjects with diagnosed metabolic syndrome will be expected to participate in the Metabolic Fitness Program which is a University of Michigan diet exercise program located in the Cardiology department at Domino Farms in Ann Arbor. Time required for this program and the study is 6 months. Clinic visits will involve Cardiac autonomic testing (CAN) procedures, PET scans and labs which will measure pre and post program intervention.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Cardiac Autonomic Neuropathy in Patients With Metabolic Syndrome
Study Start Date : January 2007
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Mediterranean Diet and Exercise
Mediterranean Diet and Exercise
Behavioral: Exercise and Diet (Metabolic Fitness Program)
6 month program of diet and exercise training and support.
Other Name: Metabolic Fitness Program

Primary Outcome Measures :
  1. Cardiac autonomic testing (CAN) [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. PET Scan [ Time Frame: 6 month ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Subjects must have IGT or IFG and two other criteria of metabolic syndrome as defined by ATP III (IFG=fasting glucose ≥ 100 mg/dl (5.5 mmol/l))
  2. Definition of IGT/IFG: IGT/IFG will be defined based on the ADA diagnostic guidelines following an oral glucose tolerance test (OGTT) [2].
  3. Other Required Criteria (2 of the following):

    • Waist circumference ≥ 102 cm (40 inches) in men and ≥ 88 cm (35 inches) in women, {for Asian-Americans: men ≥ 88 cm (35 inches), women ≥ 78 cm (31 inches)}
    • Triglycerides ≥ 150 mg/dl (1.7 mmol/l) - patients on drug treatment with fibrates or nicotinic acid will be presumed to have triglycerides ≥ 150mg/dl and low HDL
    • HDL cholesterol < 40 mg/dl (1.0 mmol/l) in men and < 50 mg/dl (1.3 mmol/l) in women,
    • Blood pressure ≥ 130/≥ 85 mmHg
  4. Age 18-65
  5. Women of childbearing potential must be using contraception to prevent pregnancy

Exclusion Criteria:

  1. Patients either pregnant or planning to become pregnant will be excluded

    • Women of childbearing potential will have a urine pregnancy test as part of the screening visit
    • Subjects who become pregnant during the study will undergo an exit visit and management of their IGT and Metabolic Syndrome will be returned to their primary care provider
  2. Subjects with pre-existing cardiovascular disease including:

    • myocardial infarction
    • congestive heart failure
    • known arrhythmias
    • ventricular structural abnormalities and valvular disease
    • peripheral vascular disease
  3. Subjects with hypoxemic lung or heart disease
  4. Subjects with established diabetes
  5. Laboratory evidence for a disease known to cause neuropathy within 3 months of screening will be an exclusion (those without known abnormality or those with a remote abnormality (> 3 months) will undergo the serologic screening)
  6. Significant neurological disease (e.g., Parkinson's disease, epilepsy, recent stroke)
  7. Subjects taking drugs which interfere with the uptake or metabolism of catecholamines
  8. Subjects with known history of chronic kidney disease or who have significant hepatic disease (AST, ALT > 3 times upper limit for normal) or a history of previous kidney, pancreas or cardiac transplantation.
  9. Subjects having taken systemic investigational drugs within the last 6 months
  10. Inability or unwillingness of subject or legal guardian/representative to give written informed consent

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): NCT00907127

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United States, Michigan
The University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
American Diabetes Association
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Principal Investigator: Rodica Pop-Busui, MD, PhD University of Michigan
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Rodica Pop-Busui, Associate Professor of Internal Medicine/MEND, University of Michigan Identifier: NCT00907127    
Other Study ID Numbers: UM-5428
First Posted: May 22, 2009    Key Record Dates
Last Update Posted: December 17, 2013
Last Verified: December 2013
Keywords provided by Rodica Pop-Busui, University of Michigan:
Additional relevant MeSH terms:
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Metabolic Syndrome
Pathologic Processes
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases