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Italian Diabetes and Exercise Study 2 (IDES-2)

This study has been completed.
University of Roma La Sapienza
Information provided by (Responsible Party):
Giuseppe Pugliese, Metabolic Fitness Association, Italy Identifier:
First received: May 16, 2012
Last updated: March 22, 2017
Last verified: March 2017
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 Intervention
Type 2 Diabetes Behavioral: Theoretical & practical exercise counseling

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Giuseppe Pugliese, Metabolic Fitness Association, Italy:

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

  • Modifiable cardiovascular risk factors [ Time Frame: 3 years ]
    Modifiable cardiovascular risk factors (HbA1c, lipids, blood pressure, C-reactive protein, CHD 10-year risk scores)

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

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

Enrollment: 300
Study Start Date: October 2012
Study Completion Date: February 28, 2017
Primary Completion Date: February 28, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.


Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
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
  Contacts and Locations
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Please refer to this study by its identifier: 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
  More Information

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
Study First Received: May 16, 2012
Last Updated: March 22, 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 processed this record on September 20, 2017