NCT04910997

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, for increasing aerobic capacity of individuals with type 2 diabetes, compared to a traditional exercise training paradigm and usual care. To accomplish this aim the investigators plan to test for greater improvements in: 1) fitness (primary outcome); as well as secondary variables of 2) cardiovascular autonomic function via baroreflex function; 3) glucose control (HbA1c); and 4) psychosocial factors.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2021

Shorter than P25 for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2021

Completed
14 days until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 2, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2022

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 3, 2022

Completed
Last Updated

April 18, 2023

Status Verified

April 1, 2023

Enrollment Period

11 months

First QC Date

May 18, 2021

Last Update Submit

April 13, 2023

Conditions

Type 2 DiabetesDiabetes Mellitus, Type 2Type 2 Diabetes Mellitus in Obese

Keywords

ExerciseAerobic exerciseExercise trainingGlucose controlAutonomic function

Outcome Measures

Primary Outcomes (1)

  • Peak aerobic capacity (fitness)

    Aerobic capacity (e.g. fitness) will be measured during a treadmill test that assess how much oxygen the muscles need during exercise. Aerobic capacity (VO2peak) will be reported as mL/min/kg.

    4 months

Secondary Outcomes (5)

  • Glucose control

    4 months

  • Baroreflex sensitivity

    4 months

  • Quality of life questionnaire

    4 months

  • Fatigue severity scale

    4 months

  • Depression questionnaire

    4 months

Study Arms (3)

HRV Group

EXPERIMENTAL

Heart rate variability training group

Other: Aerobic exercise training

Traditional Exercise Group

ACTIVE COMPARATOR

Traditional (e.g. standard) exercise training

Other: Aerobic exercise training

Control Group

NO INTERVENTION

Usual care

Interventions

Aerobic exercise trainingOTHER

Combination of supervised and home-based aerobic exercise training

HRV GroupTraditional Exercise Group

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60608, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Motor Activity

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavior

Study Officials

  • Baynard

    University of Illinois at Chicago

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 18, 2021

First Posted

June 2, 2021

Study Start

June 1, 2021

Primary Completion

May 2, 2022

Study Completion

May 3, 2022

Last Updated

April 18, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)