Italian Diabetes and Exercise Study 2 (IDES-2)

March 22, 2017 updated by: Giuseppe Pugliese, Metabolic Fitness Association, Italy

Italian Diabetes and Exercise Study 2 - A Long-term Behavioural Intervention for Adoption and Maintenance of a Physically Active Lifestyle

Current guidelines recommend supervised mixed (aerobic+resistance) physical activity to ensure optimal benefits to control blood glucose, lipids, blood pressure, and other cardiovascular risk and to minimize injuries. However, these guidelines are difficult to put into action for a number of barriers and poor long-term patient compliance. This project will assess the effect of a behavioral intervention strategy on the promotion and maintenance of physical activity in type 2 diabetes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

An increasing prevalence of type 2 diabetes is associated with an aging population, a significant rise in the prevalence of obesity, and a sedentary lifestyle. In Italy, prevalence of diabetes is approximately 6%, with 90-95% of diabetic subjects having type 2. Strong evidence supports the importance of physical activity in the management of type 2 diabetes. However, current guidelines are difficult to put into action in this target population because of barriers and poor patient long-term compliance so it is difficult even identify the best strategies for physical activity behavior change. Existing studies employ small groups and clinically-based approaches with limited theoretical grounding for recommended health behavior change. Most fail to offer practical, sustainable, economically viable solutions, with documented long-term intervention efficacy. This study proposes to monitor any objective measurable changes in LTPA over a 3-year period after behavioral interventions (Physician recommendations for daily PA with and without supervised exercise training including individual theoretic & practical counseling). Hopefully, such behavioral intervention would offer a feasible procedure for long-term maintenance of physical activity and thus meet the call for a change of paradigm to move beyond the limited clinical focus by including theoretically population-based and "real-life" approaches for the management Type 2 Diabetes.

After the selection for eligibility and a run-in period, patients will be randomized in two groups: 1) exercise (EXE) group receiving theoretical & practical exercise counseling including 2 sessions/ per wk for 1 month of supervised exercise training; and 2) control (CON) group receiving standard care including general physician recommendations for daily PA. Changes in physical activity behavior will be quantified using an accelerometer, in addition to a daily diary.

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • RM
      • Rome, RM, Italy, 00189
        • University of Rome La Sapienza, Department of Clinical and Molecular Medicine, Sant'Andrea Hospital, Diabetes Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

36 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Type 2 diabetes
  2. Age 40 to 80 years at screening
  3. BMI >27<40 kg/m2
  4. Sedentary for at least 6 months
  5. Treated with prescribed diet and/or OHA and insulin
  6. Able to walk for 1.6 Km unaided.
  7. Eligible after positive outcome of cardiac evaluation

Exclusion Criteria:

  1. All patients with a history of central nervous dysfunction such as hemiparesis, myelopathies, cerebral ataxia, significant musculoskeletal deformities such as an amputation, dysmetria or scoliosis, patients with movement abnormalities or arthritis limited by pain when exercising
  2. A history of clinical evidence of severe cardiovascular disease which may limit or be a contraindication for exercise
  3. Clinical evidence of vestibular dysfunction
  4. Angina and related symptoms
  5. Postural hypotension defined as a fall in arterial blood pressure when changing position of >20 mmHg (systole) or >10 mmHg (diastole
  6. History of plantar sores

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Standard care including physician recommendations for daily PA
Experimental: Exercise
Theoretical & practical exercise counseling including 2 sessions/ per wk for 1 month of supervised exercise training
Behavioral: Theoretical & practical exercise counseling
2 sessions/ per wk for 1 month

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical Activity Behavior
Time Frame: 3 years
Volume of physical activity in METs-hr/wk; sedentary time; time spent in moderate-to-vigorous physical activity
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical fitness
Time Frame: 3 years
Physical fitness (Cardiorespiratory, fitness, muscle strength, hip and trunk flexibility)
3 years
Modifiable cardiovascular risk factors
Time Frame: 3 years
Modifiable cardiovascular risk factors (HbA1c, lipids, blood pressure, C-reactive protein, CHD 10-year risk scores)
3 years
Health related quality of life
Time Frame: 3 years
Quality of life (Physical and mental SF-36 scores)
3 years
Musculo-skeletal disturbances
Time Frame: 3 years
Musculo-skeletal symproms and scores
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Metabolic Fitness Association, Italy

Collaborators

University of Roma La Sapienza

Investigators

  • Study Director: Stefano Balducci, MD, Sant'Andrea Hospital, Diabetes Unit

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

February 28, 2017

Study Completion (Actual)

February 28, 2017

Study Registration Dates

First Submitted

May 16, 2012

First Submitted That Met QC Criteria

May 16, 2012

First Posted (Estimate)

May 17, 2012

Study Record Updates

Last Update Posted (Actual)

March 24, 2017

Last Update Submitted That Met QC Criteria

March 22, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MFA-12-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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