Italian Diabetes and Exercise Study 2

Type 2 Diabetes Clinical Trial

— IDES-2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01600937
• Other study ID #: MFA-12-01
• Status: Completed
• Phase: N/A
• First received: May 16, 2012
• Last updated: March 22, 2017
• Start date: October 2012
• Est. completion date: February 28, 2017

Study information

• Verified date: March 2017
• Source: Metabolic Fitness Association, Italy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: February 28, 2017
• Est. primary completion date: February 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Type 2 Diabetes

Intervention

Behavioral:
• Theoretical & practical exercise counseling
2 sessions/ per wk for 1 month

Locations

Country	Name	City	State
Italy	University of Rome La Sapienza, Department of Clinical and Molecular Medicine, Sant'Andrea Hospital, Diabetes Unit	Rome	RM

Sponsors (2)

Lead Sponsor	Collaborator
Metabolic Fitness Association, Italy	University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

References & Publications (13)

Balducci S, Alessi E, Cardelli P, Cavallo S, Fallucca F, Pugliese G. Effects of different modes of exercise training on glucose control and risk factors for complications in type 2 diabetic patients: a meta-analysis: response to Snowling and Hopkins. Diabetes Care. 2007 Apr;30(4):e25; author reply e26. — View Citation

Balducci S, Zanuso S, Cardelli P, Salerno G, Fallucca S, Nicolucci A, Pugliese G; Italian Diabetes Exercise Study (IDES) Investigators.. Supervised exercise training counterbalances the adverse effects of insulin therapy in overweight/obese subjects with type 2 diabetes. Diabetes Care. 2012 Jan;35(1):39-41. doi: 10.2337/dc11-1450. — View Citation

Balducci S, Zanuso S, Cardelli P, Salvi L, Mazzitelli G, Bazuro A, Iacobini C, Nicolucci A, Pugliese G; Italian Diabetes Exercise Study (IDES) Investigators.. Changes in physical fitness predict improvements in modifiable cardiovascular risk factors independently of body weight loss in subjects with type 2 diabetes participating in the Italian Diabetes and Exercise Study (IDES). Diabetes Care. 2012 Jun;35(6):1347-54. doi: 10.2337/dc11-1859. — View Citation

Balducci S, Zanuso S, Fernando F, Fallucca S, Fallucca F, Pugliese G; Italian Diabetes Exercise Study (IDES) Group.. Physical activity/exercise training in type 2 diabetes. The role of the Italian Diabetes and Exercise Study. Diabetes Metab Res Rev. 2009 Sep;25 Suppl 1:S29-33. doi: 10.1002/dmrr.985. Review. — View Citation

Balducci S, Zanuso S, Massarini M, Corigliano G, Nicolucci A, Missori S, Cavallo S, Cardelli P, Alessi E, Pugliese G, Fallucca F; Italian Diabetes Exercise Study (IDES) Group.. The Italian Diabetes and Exercise Study (IDES): design and methods for a prospective Italian multicentre trial of intensive lifestyle intervention in people with type 2 diabetes and the metabolic syndrome. Nutr Metab Cardiovasc Dis. 2008 Nov;18(9):585-95. — View Citation

Balducci S, Zanuso S, Nicolucci A, De Feo P, Cavallo S, Cardelli P, Fallucca S, Alessi E, Fallucca F, Pugliese G; Italian Diabetes Exercise Study (IDES) Investigators.. Effect of an intensive exercise intervention strategy on modifiable cardiovascular risk factors in subjects with type 2 diabetes mellitus: a randomized controlled trial: the Italian Diabetes and Exercise Study (IDES). Arch Intern Med. 2010 Nov 8;170(20):1794-803. doi: 10.1001/archinternmed.2010.380. — View Citation

Balducci S, Zanuso S, Nicolucci A, Fernando F, Cavallo S, Cardelli P, Fallucca S, Alessi E, Letizia C, Jimenez A, Fallucca F, Pugliese G. Anti-inflammatory effect of exercise training in subjects with type 2 diabetes and the metabolic syndrome is dependent on exercise modalities and independent of weight loss. Nutr Metab Cardiovasc Dis. 2010 Oct;20(8):608-17. doi: 10.1016/j.numecd.2009.04.015. — View Citation

Balducci S, Zanuso S, Pugliese G, Church T, Sigal RJ. Diet or diet plus physical activity in patients with early type 2 diabetes. Lancet. 2011 Dec 17;378(9809):2066; author reply 2067-8. doi: 10.1016/S0140-6736(11)61891-6. — View Citation

Nicolucci A, Balducci S, Cardelli P, Cavallo S, Fallucca S, Bazuro A, Simonelli P, Iacobini C, Zanuso S, Pugliese G; Italian Diabetes Exercise Study Investigators.. Relationship of exercise volume to improvements of quality of life with supervised exercise training in patients with type 2 diabetes in a randomised controlled trial: the Italian Diabetes and Exercise Study (IDES). Diabetologia. 2012 Mar;55(3):579-88. doi: 10.1007/s00125-011-2425-9. — View Citation

Nicolucci A, Balducci S, Cardelli P, Zanuso S, Pugliese G; Italian Diabetes Exercise Study (IDES) Investigators.. Improvement of quality of life with supervised exercise training in subjects with type 2 diabetes mellitus. Arch Intern Med. 2011 Nov 28;171(21):1951-3. doi: 10.1001/archinternmed.2011.561. — View Citation

Pugliese G, Zanuso S, Alessi E, Simonelli P, Fallucca S, Fallucca F, Balducci S. Self glucose monitoring and physical exercise in diabetes. Diabetes Metab Res Rev. 2009 Sep;25 Suppl 1:S11-7. doi: 10.1002/dmrr.982. Review. — View Citation

Zanuso S, Balducci S, Gutierrez AJ, Bergamin M, Pugliese G. Similar energy expenditure from resistance training at moderate and vigorous intensity in subjects with type 2 diabetes. Diabetes Res Clin Pract. 2009 Sep;85(3):e40-1. doi: 10.1016/j.diabres.2009.05.003. — View Citation

Zanuso S, Jimenez A, Pugliese G, Corigliano G, Balducci S. Exercise for the management of type 2 diabetes: a review of the evidence. Acta Diabetol. 2010 Mar;47(1):15-22. doi: 10.1007/s00592-009-0126-3. Review. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical Activity Behavior	Volume of physical activity in METs-hr/wk; sedentary time; time spent in moderate-to-vigorous physical activity	3 years
Secondary	Physical fitness	Physical fitness (Cardiorespiratory, fitness, muscle strength, hip and trunk flexibility)	3 years
Secondary	Modifiable cardiovascular risk factors	Modifiable cardiovascular risk factors (HbA1c, lipids, blood pressure, C-reactive protein, CHD 10-year risk scores)	3 years
Secondary	Health related quality of life	Quality of life (Physical and mental SF-36 scores)	3 years
Secondary	Musculo-skeletal disturbances	Musculo-skeletal symproms and scores	3 years

External Links

•   Study protocol