Cardiac Autonomic Neuropathy in Patients With Metabolic Syndrome

NCT00907127 | Completed Phase 1

• 2 other identifiers: UM-5428ADA
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Metabolic Syndrome

Keywords

Metabolic; Syndrome; CAN

Outcome Measures

Primary Outcomes (1)

• Cardiac autonomic testing (CAN)

  6 months

Secondary Outcomes (1)

• PET Scan

  6 month

Study Arms (1)

Mediterranean Diet and Exercise

ACTIVE COMPARATOR

Mediterranean Diet and Exercise

Behavioral: Exercise and Diet (Metabolic Fitness Program)

Interventions

Exercise and Diet (Metabolic Fitness Program) BEHAVIORAL

6 month program of diet and exercise training and support.

Also known as: Metabolic Fitness Program

Mediterranean Diet and Exercise

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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))
• Definition of IGT/IFG: IGT/IFG will be defined based on the ADA diagnostic guidelines following an oral glucose tolerance test (OGTT) \[2\].
• 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
• Age 18-65
• Women of childbearing potential must be using contraception to prevent pregnancy

You may not qualify if:

• 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
• Subjects with pre-existing cardiovascular disease including:
• myocardial infarction
• congestive heart failure
• known arrhythmias
• ventricular structural abnormalities and valvular disease
• peripheral vascular disease
• Subjects with hypoxemic lung or heart disease
• Subjects with established diabetes
• Significant neurological disease (e.g., Parkinson's disease, epilepsy, recent stroke)
• Subjects taking drugs which interfere with the uptake or metabolism of catecholamines
• 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.
• Subjects having taken systemic investigational drugs within the last 6 months

Sponsors & Collaborators

• University of Michigan: lead
• American Diabetes Association: collaborator

Study Sites (1)

The University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

• 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.

  PMID: 30201848 DERIVED

MeSH Terms

Conditions

Metabolic Syndrome; Syndrome

Interventions

Exercise; Diet

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Rodica Pop-Busui, MD, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Internal Medicine/MEND

Study Record Dates

• First Submitted: May 20, 2009
• First Posted: May 22, 2009
• Study Start: January 1, 2007
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: December 17, 2013

Record last verified: 2013-12

Locations

US (1)