Type 2 DiabetesIDES-2NCT01600937
Italian Diabetes and Exercise Study 2
A study testing Theoretical & practical exercise counseling in people with Type 2 Diabetes, run by Metabolic Fitness Association, Italy at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Theoretical & practical exercise counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2012to 28 Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site
University of Rome La Sapienza, Department of Clinical and Molecular Medicine, Sant'Andrea Hospital, Diabetes Unit
Rome, RM, 00189
About this study
Official title: 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.
Read the 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.
- Conditions
- Type 2 Diabetes
- Being tested
- Theoretical & practical exercise counseling
- Keywords
- diabetes mellitus, diabetes education, behavioral therapy, behavior modification, physical activity, supervised exercise, physical fitness, HbA1c, modifiable cardiovascular risk factors, quality of life
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Theoretical & practical exercise counselingBehavioural
2 sessions/ per wk for 1 month
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Theoretical & practical exercise counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Activity Behavior
Volume of physical activity in METs-hr/wk; sedentary time; time spent in moderate-to-vigorous physical activity
Measured: 3 years
Secondary outcomes (4)
Physical fitness
Physical fitness (Cardiorespiratory, fitness, muscle strength, hip and trunk flexibility)
Measured: 3 years
Modifiable cardiovascular risk factors
Modifiable cardiovascular risk factors (HbA1c, lipids, blood pressure, C-reactive protein, CHD 10-year risk scores)
Measured: 3 years
Health related quality of life
Quality of life (Physical and mental SF-36 scores)
Measured: 3 years
Musculo-skeletal disturbances
Musculo-skeletal symproms and scores
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2012 (estimated)
- Study startOct 2012
- Primary completion28 Feb 2017
- Study completion28 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Metabolic Fitness Association, Italy
- Sponsor type
- University, hospital or other
- Collaborators
- University of Roma La Sapienza
- Responsible party
- Principal investigator, Giuseppe Pugliese, Metabolic Fitness Association, Italy
- Investigators
- Stefano Balducci, MD, Study director, Sant'Andrea Hospital, Diabetes Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01600937
- Sponsor's protocol ID
- MFA-12-01
- Acronym
- IDES-2
- Status last verified
- Mar 2017
- First submitted
- 16 May 2012
- Last updated
- 24 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22399699Nicolucci 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.
PubMed 22234648Balducci 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.
PubMed 22177504Nicolucci 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.
PubMed 22123809Balducci 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.
PubMed 22011409Balducci 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.
PubMed 21059972Balducci 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.
PubMed 19695853Pugliese 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.
PubMed 19662620Balducci 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.
PubMed 19662617Zanuso 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.
PubMed 19500870Zanuso 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.
PubMed 19495557Balducci 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.
PubMed 18061415Balducci 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.
PubMed 17392536Balducci 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;17(1):1930. doi: 10.1038/s41467-026-68618-7.
PubMed 41571659Balducci 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.
PubMed 37312666
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Italian Diabetes and Exercise Study 2 - A Long-term Behavioural Intervention for Adoption and Maintenance of a Physically Active Lifestyle
- ClinicalTrials.gov ID
- NCT01600937
- Acronym / sponsor ID
- IDES-2 / MFA-12-01
- Conditions
- Type 2 Diabetes
- Keywords
- diabetes mellitus, diabetes education, behavioral therapy, behavior modification, physical activity, supervised exercise, physical fitness, HbA1c
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Metabolic Fitness Association, ItalyUniversity, hospital or other
- Collaborators
- University of Roma La Sapienza
- Study start
- Oct 2012
- Primary completion
- 28 Feb 2017 (actual)
- Study completion
- 28 Feb 2017 (actual)
- First posted
- 17 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Standard care including physician recommendations for daily PA |
| Exercise | Experimental | Behavioral: Theoretical & practical exercise counselingTheoretical \& practical exercise counseling including 2 sessions/ per wk for 1 month of supervised exercise training |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Theoretical & practical exercise counseling2 sessions/ per wk for 1 month | Behavioural | Exercise |
Primary outcome
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
4 secondary outcomes
Physical fitness
Time frame: 3 years
Modifiable cardiovascular risk factors
Time frame: 3 years
Health related quality of life
Time frame: 3 years
Musculo-skeletal disturbances
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2017.
- Background: PubMed 22399699Balducci 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.
- Background: PubMed 22234648Nicolucci 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.
- Background: PubMed 22177504Balducci 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.
- Background: PubMed 22123809Nicolucci 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.
- Background: PubMed 22011409Balducci 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.
- Background: PubMed 21059972Balducci 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.
- Background: PubMed 19695853Balducci 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.
- Background: PubMed 19662620Pugliese 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.
- Background: PubMed 19662617Balducci 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.
- Background: PubMed 19500870Zanuso 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.
- Background: PubMed 19495557Zanuso 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.
- Background: PubMed 18061415Balducci 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.
- Study protocolLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefano Balducci, MD study director
Sant'Andrea Hospital, Diabetes Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Theoretical & practical exercise counseling in people with Type 2 Diabetes, run by Metabolic Fitness Association, Italy at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Activity Behavior (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01600937, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2017.