NCT00212303

Brief Summary

The coexistence of diabetes and hypertension is damaging to cardiac and peripheral vascular structure and function. Although several health organizations endorse exercise training as a treatment for type 2 diabetes, most studies of exercise and diabetes have focused on controlling blood sugar but not on cardiovascular health. The aim of this study is to determine if exercise training reduces blood pressure and improves cardiovascular health in persons who have both type 2 diabetes and hypertension. An equal number of men and women will be enrolled, and another aim of the study is to examine gender differences in response to exercise training.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
115

participants targeted

Target at P50-P75 for phase_4 type-2-diabetes

Timeline
Completed

Started May 2004

Longer than P75 for phase_4 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, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

January 23, 2013

Status Verified

January 1, 2013

Enrollment Period

6.6 years

First QC Date

September 13, 2005

Last Update Submit

January 18, 2013

Conditions

Type 2 DiabetesHypertension

Keywords

type 2 diabeteshypertensionexercise trainingcardiac, peripheralbody compositionphysical fitnessinflammation

Outcome Measures

Primary Outcomes (1)

  • Blood pressure at 6 months

    6 months

Secondary Outcomes (4)

  • Cardiac and peripheral structure and function at 6 months

    6 months

  • Fitness and body composition at 6 months

    6 months

  • Cardiac and diabetes risk factors at 6 months

    6 months

  • Systemic inflammation at 6 months

    6 months

Study Arms (2)

Exercise training

EXPERIMENTAL

Exercise training, 3 times per week, for 6 months.

Behavioral: Exercise training for 6 months

Control

NO INTERVENTION

Usual care no active exercise intervention

Interventions

Exercise training for 6 monthsBEHAVIORAL

Exercise 3 times/week for 6 months. Exercise consists of aerobic and resistance exercise

Exercise training

Eligibility Criteria

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

You may qualify if:

  • ages 40-65 years type 2 diabetes BP between SBP 120-159 or DBP 80-99 mm Hg sedentary

You may not qualify if:

  • cardiovascular disease abnormal exercise stress test smoking insulin use major illnesses that would preclude exercise training pregnancy in women engaged in regular exercise or weight loss diet program substance abuse morbid obesity BMI \> 42

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

Related Publications (6)

  • Dobrosielski DA, Barone Gibbs B, Chaudhari S, Ouyang P, Silber HA, Stewart KJ. Effect of exercise on abdominal fat loss in men and women with and without type 2 diabetes. BMJ Open. 2013 Nov 25;3(11):e003897. doi: 10.1136/bmjopen-2013-003897.

    PMID: 24282247DERIVED

  • Barone Gibbs B, Dobrosielski DA, Althouse AD, Stewart KJ. The effect of exercise training on ankle-brachial index in type 2 diabetes. Atherosclerosis. 2013 Sep;230(1):125-30. doi: 10.1016/j.atherosclerosis.2013.07.002. Epub 2013 Jul 14.

    PMID: 23958264DERIVED

  • Nam S, Dobrosielski DA, Stewart KJ. Predictors of exercise intervention dropout in sedentary individuals with type 2 diabetes. J Cardiopulm Rehabil Prev. 2012 Nov-Dec;32(6):370-8. doi: 10.1097/HCR.0b013e31826be485.

    PMID: 23011489DERIVED

  • Gibbs BB, Dobrosielski DA, Lima M, Bonekamp S, Stewart KJ, Clark JM. The association of arterial shear and flow-mediated dilation in diabetes. Vasc Med. 2011 Aug;16(4):267-74. doi: 10.1177/1358863X11411361. Epub 2011 Jun 27.

    PMID: 21708874DERIVED

  • Moseley KF, Dobrosielski DA, Stewart KJ, Sellmeyer DE, Jan De Beur SM. Lean mass predicts hip geometry in men and women with non-insulin-requiring type 2 diabetes mellitus. J Clin Densitom. 2011 Jul-Sep;14(3):332-9. doi: 10.1016/j.jocd.2011.04.007. Epub 2011 Jun 11.

    PMID: 21652249DERIVED

  • Bennett WL, Ouyang P, Wu AW, Barone BB, Stewart KJ. Fatness and fitness: how do they influence health-related quality of life in type 2 diabetes mellitus? Health Qual Life Outcomes. 2008 Dec 4;6:110. doi: 10.1186/1477-7525-6-110.

    PMID: 19055828DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2HypertensionInflammation

Interventions

Exercise

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Kerry J Stewart, EdD

    Johns Hopkins School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

May 1, 2004

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

January 23, 2013

Record last verified: 2013-01

Locations

US(1)