Status:

WITHDRAWN

Heart Rate Variability-Guided Exercise Training in Type 2 Diabetes

Lead Sponsor:

University of Illinois at Chicago

Collaborating Sponsors:

American Diabetes Association

Conditions:

Type 2 Diabetes

Diabetes Mellitus, Type 2

Eligibility:

All Genders

40-70 years

Phase:

NA

Brief Summary

The primary aim of this randomized clinical trial is to determine the effectiveness of a 16 wk individualized aerobic exercise program, using heart rate variability to guide the exercise prescription,...

Detailed Description

This study will examine participant's fitness levels before and after a 16 week intervention period. There are two study visits prior to starting the intervention period. During Baseline Study Visit #...

Eligibility Criteria

Inclusion

  • Body mass index range = 30.0 to 40.0 kg/m2
  • Being sedentary (\<1 h regular physical activity/wk)
  • Medication stable for 3 mo.
  • Current use of physician confirmed diabetes medication, fasting glucose values ≥ 126 mg/dL and 2 hr oral glucose tolerance test (OGTT) values ≥ 200 mg/dL will be used as the criteria for type 2 diabetes

Exclusion

  • Type 1 diabetes, \[insulin use\]
  • Major depressive disorder
  • Severe neuropathy
  • Current tobacco use (must have quit for 1 yr or more if a previous user)
  • Renal, liver, peripheral artery, or carotid artery disease
  • Current cancer (must be at least 6 mo cancer-free)
  • Beta-blockers
  • Perimenopausal women, post-menopausal women experiencing hot flushes and not on hormone therapy
  • Alcohol consumption greater than 7 drinks/wk
  • Acute coronary syndrome within the last 6 mo, heart failure, pacemaker, and any additional contraindications to participation in exercise testing or an exercise training program.

Key Trial Info

Start Date :

June 1 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 3 2022

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT04910997

Start Date

June 1 2021

End Date

May 3 2022

Last Update

April 18 2023

Active Locations (1)

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1

University of Illinois at Chicago

Chicago, Illinois, United States, 60608