Italian Diabetes and Exercise Study 2 (IDES-2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01600937
Recruitment Status : Completed
First Posted : May 17, 2012
Last Update Posted : March 24, 2017
University of Roma La Sapienza
Information provided by (Responsible Party):
Giuseppe Pugliese, Metabolic Fitness Association, Italy

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Behavioral: Theoretical & practical exercise counseling Not Applicable

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  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Italian Diabetes and Exercise Study 2 - A Long-term Behavioural Intervention for Adoption and Maintenance of a Physically Active Lifestyle
Study Start Date : October 2012
Actual Primary Completion Date : February 28, 2017
Actual Study Completion Date : February 28, 2017

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. Physical fitness [ Time Frame: 3 years ]
    Physical fitness (Cardiorespiratory, fitness, muscle strength, hip and trunk flexibility)

  2. 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. Health related quality of life [ Time Frame: 3 years ]
    Quality of life (Physical and mental SF-36 scores)

  4. Musculo-skeletal disturbances [ Time Frame: 3 years ]
    Musculo-skeletal symproms and scores

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01600937

University of Rome La Sapienza, Department of Clinical and Molecular Medicine, Sant'Andrea Hospital, Diabetes Unit
Rome, RM, Italy, 00189
Sponsors and Collaborators
Metabolic Fitness Association, Italy
University of Roma La Sapienza
Study Director: Stefano Balducci, MD Sant'Andrea Hospital, Diabetes Unit

Additional Information:

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Giuseppe Pugliese, MD, PhD, Metabolic Fitness Association, Italy Identifier: NCT01600937     History of Changes
Other Study ID Numbers: MFA-12-01
First Posted: May 17, 2012    Key Record Dates
Last Update Posted: March 24, 2017
Last Verified: March 2017

Keywords provided by Giuseppe Pugliese, Metabolic Fitness Association, Italy:
diabetes mellitus
diabetes education
behavioral therapy
behavior modification
physical activity
supervised exercise
physical fitness
modifiable cardiovascular risk factors
quality of life

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases