Cardiac Autonomic Neuropathy in Patients With Metabolic Syndrome (CAN)

This study has been completed.
Sponsor:
Collaborator:
American Diabetes Association
Information provided by (Responsible Party):
Rodica Pop-Busui, University of Michigan
ClinicalTrials.gov Identifier:
NCT00907127
First received: May 20, 2009
Last updated: December 13, 2013
Last verified: December 2013
  Purpose

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


Condition Intervention Phase
Metabolic Syndrome
Behavioral: Exercise and Diet (Metabolic Fitness Program)
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Cardiac Autonomic Neuropathy in Patients With Metabolic Syndrome

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Cardiac autonomic testing (CAN) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PET Scan [ Time Frame: 6 month ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: January 2007
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00907127

Locations
United States, Michigan
The University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
American Diabetes Association
Investigators
Principal Investigator: Rodica Pop-Busui, MD, PhD University of Michigan
  More Information

No publications provided

Responsible Party: Rodica Pop-Busui, Associate Professor of Internal Medicine/MEND, University of Michigan
ClinicalTrials.gov Identifier: NCT00907127     History of Changes
Other Study ID Numbers: UM-5428, ADA
Study First Received: May 20, 2009
Last Updated: December 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
Metabolic
Syndrome
CAN

Additional relevant MeSH terms:
Nervous System Diseases
Metabolic Syndrome X
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on September 11, 2014