NCT01883258

Brief Summary

The study objectives are:

  1. 1.To compare cardiovascular function in type 2 diabetes patients vs. healthy controls.
  2. 2.To compare the effect of 8 weeks of aerobic interval training versus continuous moderate exercise on cardiovascular function in adults with type 2 diabetes.
  3. 3.To examine the mechanisms underlying the exercise-related changes in cardiovascular function.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
116

participants targeted

Target at P50-P75 for not_applicable type-2-diabetes

Timeline
Completed

Started May 2013

Longer than P75 for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

May 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 13, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 21, 2013

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 16, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 16, 2018

Completed
Last Updated

December 6, 2019

Status Verified

December 1, 2019

Enrollment Period

5.2 years

First QC Date

June 13, 2013

Last Update Submit

December 5, 2019

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Change in vascular endothelial function

    Brachial flow mediated dilation using ultrasonography

    At baseline and after 8 weeks of exercise training

Secondary Outcomes (4)

  • Change in factors related with endothelial function

    At baseline and after 8 weeks of exercise training

  • Change in arterial stiffness

    At baseline and after 8 weeks of exercise training

  • Change in cardiac function

    At baseline and after 8 weeks of exercise training

  • Change in maximal oxygen consumption

    At baseline and after 8 weeks of exercise training

Study Arms (4)

High intensity aerobic interval training

EXPERIMENTAL

Type 2 diabetes subjects will complete 8 weeks of high intensity aerobic interval exercise training.

Other: High intensity aerobic interval training

Continuous moderate intensity exercise

EXPERIMENTAL

Type 2 diabetes subjects will complete 8 weeks of continuous moderate intensity exercise training.

Other: Continuous moderate intensity exercise

Non-exercise control group

NO INTERVENTION

Type 2 diabetes subjects assigned to the non-exercise control group will maintain their normal lifestyle for 8 weeks.

Healthy control group

NO INTERVENTION

Healthy subjects will be assigned to the healthy control group and will undergo baseline measures only.

Interventions

High intensity aerobic interval trainingOTHER

Supervised aerobic interval training will be performed on bicycles 4 times per week for 8 weeks. Each training session will last 40 minutes and will consist of 10-minute warm up at 70% of maximal heart rate (HRmax), four 4-minute intervals at 90% of HRmax with 3-min active recovery at 70% of HRmax and 5-minute cool down at 70% of HRmax.

High intensity aerobic interval training
Continuous moderate intensity exerciseOTHER

Supervised exercise training will be performed on bicycles 4 times per week for 8 weeks. Each training session will last 47 minutes and will consist of continuous moderate intensity cycling at 70% of HRmax.

Continuous moderate intensity exercise

Eligibility Criteria

Age30 Years - 79 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of type 2 diabetes
  • Sedentary or minimally physically active for at least the prior 1 year
  • Able to give consent
  • Sedentary or minimally physically active for at least the prior 1 year
  • Able to give consent

You may not qualify if:

  • History of diabetic proliferative retinopathy, autonomic or peripheral neuropathy
  • History of any relevant cardiovascular diseases (myocardial infarction, angina pectoris, history of coronary artery bypass surgery or angioplasty, congestive heart failure, or arrhythmia)
  • Hypertension (≥160 mmHg systolic or ≥100 mmHg diastolic)
  • History of renal impairment
  • History of gout or hyperuricemia
  • History of hepatic disease or infection with hepatitis B, C
  • History of seizures, or other relevant on-going or recurrent illness
  • Recent (within 3 months) or recurrent hospitalizations
  • Use of tobacco products
  • \>5 % weight change in the prior 6 months.
  • Current intake of medications that may affect study results
  • Premenopausal women taking oral contraceptives and postmenopausal women taking hormone replacement therapy.
  • Pregnancy (positive urine pregnancy test) or lactation
  • For the healthy control group, history of diabetes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida

Gainesville, Florida, 32611, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Demetra D Christou, Ph.D

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2013

First Posted

June 21, 2013

Study Start

May 1, 2013

Primary Completion

July 16, 2018

Study Completion

July 16, 2018

Last Updated

December 6, 2019

Record last verified: 2019-12

Locations

US(1)