Italian Diabetes and Exercise Study 2

NCT01600937 | Completed

• 1 other identifier: MFA-12-01
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Keywords

diabetes mellitus; diabetes education; behavioral therapy; behavior modification; physical activity; supervised exercise; physical fitness; HbA1c; modifiable cardiovascular risk factors; quality of life

Outcome Measures

Primary Outcomes (1)

• Physical Activity Behavior

  Volume of physical activity in METs-hr/wk; sedentary time; time spent in moderate-to-vigorous physical activity

  3 years

Secondary Outcomes (4)

• Physical fitness

  3 years

• Modifiable cardiovascular risk factors

  3 years

• Health related quality of life

  3 years

• Musculo-skeletal disturbances

  3 years

Study Arms (2)

Control

NO INTERVENTION

Standard care including physician recommendations for daily PA

Exercise

EXPERIMENTAL

Theoretical \& practical exercise counseling including 2 sessions/ per wk for 1 month of supervised exercise training

Behavioral: Theoretical & practical exercise counseling

Interventions

Theoretical & practical exercise counseling BEHAVIORAL

2 sessions/ per wk for 1 month

Exercise

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• A history of clinical evidence of severe cardiovascular disease which may limit or be a contraindication for exercise
• Clinical evidence of vestibular dysfunction
• Angina and related symptoms
• Postural hypotension defined as a fall in arterial blood pressure when changing position of \>20 mmHg (systole) or \>10 mmHg (diastole
• History of plantar sores

Sponsors & Collaborators

• Metabolic Fitness Association, Italy: lead
• University of Roma La Sapienza: collaborator

Study Sites (1)

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

Rome, RM, 00189, Italy

Location

Related Publications (21)

• 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. Epub 2012 Mar 7.

  PMID: 22399699 BACKGROUND

• 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. Epub 2012 Jan 11.

  PMID: 22234648 BACKGROUND

• 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. No abstract available.

  PMID: 22177504 BACKGROUND

• 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. No abstract available.

  PMID: 22123809 BACKGROUND

• 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. Epub 2011 Oct 19.

  PMID: 22011409 BACKGROUND

• 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.

  PMID: 21059972 BACKGROUND

• 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. Epub 2009 Aug 19.

  PMID: 19695853 BACKGROUND

• 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.

  PMID: 19662620 BACKGROUND

• 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.

  PMID: 19662617 BACKGROUND

• 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. Epub 2009 Jun 4. No abstract available.

  PMID: 19500870 BACKGROUND

• 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. Epub 2009 Jun 3.

  PMID: 19495557 BACKGROUND

• 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. doi: 10.1016/j.numecd.2007.07.006. Epub 2007 Dec 3.

  PMID: 18061415 BACKGROUND

• 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. doi: 10.2337/dc06-2495. No abstract available.

  PMID: 17392536 BACKGROUND

• Balducci S, Haxhi J, Vitale M, Mattia L, Calvi F, Marini M, Ciocca E, Auccello F, Gentile A, Sacchetti M, Orlando G, Zanuso S, Nicolucci A, Pugliese G; Italian Diabetes and Exercise Study 2 (IDES_2) Investigators. Effect of a behavioral counseling for adoption and maintenance of a physically active lifestyle on long-term mortality in people with type 2 diabetes: post hoc analysis of the Italian Diabetes and Exercise Study_2. Nat Commun. 2026 Jan 22. doi: 10.1038/s41467-026-68618-7. Online ahead of print.

  PMID: 41571659 DERIVED

• Balducci S, Haxhi J, Vitale M, Mattia L, Sacchetti M, Orlando G, Cardelli P, Iacobini C, Bollanti L, Conti F, Zanuso S, Nicolucci A, Pugliese G; Italian Diabetes and Exercise Study 2 (IDES_2) Investigators. Sustained increase in physical fitness independently predicts improvements in cardiometabolic risk profile in type 2 diabetes. Diabetes Metab Res Rev. 2023 Sep;39(6):e3671. doi: 10.1002/dmrr.3671. Epub 2023 Jun 14.

  PMID: 37312666 DERIVED

• Balducci S, Haxhi J, Sacchetti M, Orlando G, Cardelli P, Vitale M, Mattia L, Iacobini C, Bollanti L, Conti F, Zanuso S, Nicolucci A, Pugliese G; Italian Diabetes and Exercise Study 2 (IDES_2) Investigators. Relationships of Changes in Physical Activity and Sedentary Behavior With Changes in Physical Fitness and Cardiometabolic Risk Profile in Individuals With Type 2 Diabetes: The Italian Diabetes and Exercise Study 2 (IDES_2). Diabetes Care. 2022 Jan 1;45(1):213-221. doi: 10.2337/dc21-1505.

  PMID: 34728529 DERIVED

• Nicolucci A, Haxhi J, D'Errico V, Sacchetti M, Orlando G, Cardelli P, Vitale M, Bollanti L, Conti F, Zanuso S, Lucisano G, Balducci S, Pugliese G; Italian Diabetes and Exercise Study 2 (IDES_2) Investigators. Effect of a Behavioural Intervention for Adoption and Maintenance of a Physically Active Lifestyle on Psychological Well-Being and Quality of Life in Patients with Type 2 Diabetes: The IDES_2 Randomized Clinical Trial. Sports Med. 2022 Mar;52(3):643-654. doi: 10.1007/s40279-021-01556-0. Epub 2021 Oct 1.

  PMID: 34599476 DERIVED

• Balducci S, D'Errico V, Haxhi J, Sacchetti M, Orlando G, Cardelli P, Vitale M, Bollanti L, Conti F, Zanuso S, Lucisano G, Nicolucci A, Pugliese G; Italian Diabetes and Exercise Study 2 (IDES_2) Investigators. Effect of a Behavioral Intervention Strategy on Sustained Change in Physical Activity and Sedentary Behavior in Patients With Type 2 Diabetes: The IDES_2 Randomized Clinical Trial. JAMA. 2019 Mar 5;321(9):880-890. doi: 10.1001/jama.2019.0922.

  PMID: 30835309 DERIVED

• Balducci S, D'Errico V, Haxhi J, Sacchetti M, Orlando G, Cardelli P, Vitale M, Bollanti L, Conti F, Zanuso S, Nicolucci A, Pugliese G; Italian Diabetes and Exercise Study 2 (IDES-_2) Investigators. Effect of a Behavioral Intervention Strategy for Adoption and Maintenance of a Physically Active Lifestyle: The Italian Diabetes and Exercise Study 2 (IDES_2): A Randomized Controlled Trial. Diabetes Care. 2017 Nov;40(11):1444-1452. doi: 10.2337/dc17-0594. Epub 2017 Aug 18.

  PMID: 28821576 DERIVED

• Balducci S, D'Errico V, Haxhi J, Sacchetti M, Orlando G, Cardelli P, Di Biase N, Bollanti L, Conti F, Zanuso S, Nicolucci A, Pugliese G; Italian Diabetes and Exercise Study 2 (IDES_2) Investigators. Level and correlates of physical activity and sedentary behavior in patients with type 2 diabetes: A cross-sectional analysis of the Italian Diabetes and Exercise Study_2. PLoS One. 2017 Mar 14;12(3):e0173337. doi: 10.1371/journal.pone.0173337. eCollection 2017.

  PMID: 28291838 DERIVED

• Balducci S, Sacchetti M, Haxhi J, Orlando G, Zanuso S, Cardelli P, Cavallo S, D'Errico V, Ribaudo MC, Di Biase N, Salvi L, Vitale M, Bollanti L, Conti FG, Nicolucci A, Pugliese G; Italian Diabetes and Exercise Study 2 (IDES_2) Investigators. The Italian Diabetes and Exercise Study 2 (IDES-2): a long-term behavioral intervention for adoption and maintenance of a physically active lifestyle. Trials. 2015 Dec 11;16:569. doi: 10.1186/s13063-015-1088-0.

  PMID: 26651484 DERIVED

Related Links

• Study protocol

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus; Motor Activity

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Study Officials

• Stefano Balducci, MD

  Sant'Andrea Hospital, Diabetes Unit

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: May 16, 2012
• First Posted: May 17, 2012
• Study Start: October 1, 2012
• Primary Completion: February 28, 2017
• Study Completion: February 28, 2017
• Last Updated: March 24, 2017

Record last verified: 2017-03

Locations

IT (1)