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Cardiac Autonomic Neuropathy in Patients With Metabolic Syndrome (CAN)

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

Tracking Information
First Submitted Date  ICMJE May 20, 2009
First Posted Date  ICMJE May 22, 2009
Last Update Posted Date December 17, 2013
Study Start Date  ICMJE January 2007
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 20, 2009)
Cardiac autonomic testing (CAN) [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00907127 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 20, 2009)
PET Scan [ Time Frame: 6 month ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cardiac Autonomic Neuropathy in Patients With Metabolic Syndrome
Official Title  ICMJE Cardiac Autonomic Neuropathy in Patients With Metabolic Syndrome
Brief Summary The study will test whether damage of the heart nerves appears in patients before they develop diabetes.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Metabolic Syndrome
Intervention  ICMJE Behavioral: Exercise and Diet (Metabolic Fitness Program)
6 month program of diet and exercise training and support.
Other Name: Metabolic Fitness Program
Study Arms  ICMJE Active Comparator: Mediterranean Diet and Exercise
Mediterranean Diet and Exercise
Intervention: Behavioral: Exercise and Diet (Metabolic Fitness Program)
Publications * Mathew AV, Li L, Byun J, Guo Y, Michailidis G, Jaiswal M, Chen YE, Pop-Busui R, Pennathur S. Therapeutic Lifestyle Changes Improve HDL Function by Inhibiting Myeloperoxidase-Mediated Oxidation in Patients With Metabolic Syndrome. Diabetes Care. 2018 Nov;41(11):2431-2437. doi: 10.2337/dc18-0049. Epub 2018 Sep 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 13, 2013)
50
Original Estimated Enrollment  ICMJE
 (submitted: May 20, 2009)
55
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00907127
Other Study ID Numbers  ICMJE UM-5428
ADA
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rodica Pop-Busui, University of Michigan
Study Sponsor  ICMJE University of Michigan
Collaborators  ICMJE American Diabetes Association
Investigators  ICMJE
Principal Investigator: Rodica Pop-Busui, MD, PhD University of Michigan
PRS Account University of Michigan
Verification Date December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP