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☆
Introduction
Prevalence of diabetes mellitus, particularly type 2, is rapidly increasing worldwide and, although the rise is more pronounced in developing countries, Europe and North America are not spared [1]. As a consequence, the burden of the disabling long-term complications of diabetes is expected to rise, with an inevitable increase in the social and economic costs associated with the disease.
People with diabetes are at higher risk for macro- and microvascular disease than the general population [2]. The increased morbidity and mortality for cardiovascular disease (CVD) has been attributed to chronic hyperglycaemia per se and co-morbid conditions occurring in diabetic patients more frequently than in non-diabetic subjects. These conditions include central obesity, dyslipidaemia and arterial hypertension, which have been shown to cluster and associate with insulin resistance and disturbances of glucose metabolism, thus suggesting the existence of a unique pathophysiological condition, called the metabolic syndrome [3].
Sedentary habits have been associated with an increased prevalence of diabetes and the metabolic syndrome. Moreover, a low cardiorespiratory fitness was shown to be a powerful and independent predictor of all-cause- and CVD-mortality in type 2 diabetic subjects [4], [5], [6], [7]. Conversely, lifestyle-modification programmes, including physical activity, were shown to prevent the development of type 2 diabetes in high risk subjects; this was associated with significant improvements in body weight, central adiposity, HbA1c and lipid levels, insulin sensitivity and prevalence of hypertension [8], [9], [10], [11], [12], [13]. Moreover, in type 2 diabetic patients, a moderate or high level of physical activity (occupational, commuting and leisure time) reduced total and CVD mortality by improving glycaemic control and other CVD risk factors [14], [15].
The Italian Diabetes and Exercise Study (IDES) was designed to evaluate the efficacy of an intensive mixed (aerobic and resistance) exercise training programme, prescribed and supervised, on modifiable CVD risk factors, as compared with standard care including exercise counselling in type 2 diabetic subjects with the metabolic syndrome. This paper describes the study design and methods.
Section snippets
Study design
The study complies with the Declaration of Helsinki. The research protocol was approved by the locally appointed ethics committees.
Primary outcome
The primary research goal was the evaluation of the efficacy of a mixed exercise training programme, prescribed and supervised, as compared with standard care, in terms of HbA1c reduction.
Secondary outcomes
Secondary research goals included an exploration of:
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Percentage of patients in each group that after 12 months achieved one or more of the following targets: a >15% reduction of HbA1c levels; a >15% reduction of serum triglyceride levels; a >15% reduction of serum LDL-cholesterol levels; a >5% of serum
Discussion
Modifiable CVD risk factors represent the main endpoints of this study because it has been clearly demonstrated that physical exercise has a beneficial effect on CVD mortality and morbidity in type 2 diabetic patients by improving glycemic control as well as other CVD risk factors, including those clustering in the metabolic syndrome [23], [24], [25], [26], [27]. Recent evidence suggests that physical exercise also reduces inflammation, oxidative stress and endothelial dysfunction associated
Acknowledgement
This project, proposed by the Metabolic Fitness Organization of Italy, a non-profit foundation, has received the support of grants from LifeScan Italia, Johnson & Johnson Medical Spa, Novo Nordisk Ltd, Bristol Myers Squibb, Technogym SPA and Cosmed SrL. The IDES Study Group is registered as ISRCTN04252749.
References (52)
- et al.
IDF Epidemiology Task Force Consensus Group. The metabolic syndrome – a new worldwide definition
Lancet
(2005) - et al.
The Italian SF-36 health survey: transation, validation and norming
J Clin Epidemiol
(1998) - et al.
SFIDA Study Group – Italian Association of Diabetologists (AMD), Cardiovascular risk factors and metabolic control in type 2 diabetic subjects attending outpatient clinics in Italy: the SFIDA (survey of risk factors in Italian diabetic subjects by AMD) study
Nutr Metab Cardiovasc Dis
(2005) - et al.
Lipoprotein subfractions of runners and sedentary men
Metabolism
(1986) - et al.
Exercise and the endothelial cell
Int J Cardiol
(2005) - et al.
Effects of moderate-intensity exercise training on plasma biomarkers of inflammation and endothelial dysfunction in older patients with type 2 diabetes
Nutr Metab Cardiovasc Dis
(2006) - et al.
The effectiveness of interventions to increase physical activity
Am J Prev Med
(2002) - et al.
Promoting and maintaining physical activity in people with type 2 diabetes
Am J Prev Med
(2004) - et al.
Effect of a short-term circuit weight training program on glycemic control in NIDDM
Diabetes Res Clin Pract
(1998) - et al.
Combined aerobic and resistance exercise improves glycemic control and fitness in type 2 diabetes
Diabetes Res Clin Pract
(2002)
Physical activity for the treatment and prevention of metabolic syndrome
Nutr Metab Cardiovasc Dis
The rising global burden of diabetes and its complications: estimates and projections to the year 2010
Diabet Med
Diabetes, other risk factors, and 12-yr cardiovascular mortality for men screened in the Multiple Risk Factor Intervention Trial
Diabetes Care
Definition, diagnosis and classification of diabetes mellitus and its complications. Part 1: diagnosis and classification of diabetes mellitus provisional report of a WHO consultation
Diabet Med
Cardiorespiratory fitness, glycemic status, and mortality risk in men
Diabetes Care
Low cardiorespiratory fitness and physical inactivity as predictors of mortality in men with Type 2 diabetes
Ann Intern Med
Exercise capacity and mortality among men referred for exercise testing
N Engl J Med
Exercise capacity and body composition as predictors of mortality among men with diabetes
Diabetes Care
for the Finnish Diabetes Prevention Study Group. The Finnish Diabetes Prevention Study (DPS). Lifestyle intervention and 3-year results on diet and physical activity
Diabetes Care
for the Finnish Diabetes Prevention Study Group, Long-term improvement in insulin sensitivity by changing lifestyles of people with impaired glucose tolerance. 4-year results from the Finnish Diabetes Prevention Study
Diabetes
A reduced-fat diet and aerobic exercise in Japanese Americans with impaired glucose tolerance decreases intra-abdominal fat and improves insulin sensitivity but not β-cell function
Diabetes
Intensity and amount of physical activity in relation to insulin sensitivity: the Insulin Resistance Atherosclerosis Study
JAMA
Relationship of physical activity and body mass index to the risk of hypertension: a prospective study in Finland
Hypertension
Diabetes Prevention Program Research Group, Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin
N Engl J Med
Occupational, commuting, and leisure-time physical activity in relation to total and cardiovascular mortality among Finnish subjects with type 2 diabetes
Circulation
Physical activity, cardiovascular risk factors, and mortality among Finnish adults with diabetes
Diabetes Care
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Volume-dependent effect of supervised exercise training on fatty liver and visceral adiposity index in subjects with type 2 diabetes The Italian Diabetes Exercise Study (IDES)
2015, Diabetes Research and Clinical PracticeCitation Excerpt :Energy expenditure from aerobic exercise during supervised sessions was calculated automatically by the machines from workload (i.e. the combination of speed and slope for treadmill, steps per minute for step and power for ergometer), whereas, for resistance exercise, an estimate of 3 METs-hr was established [18,19]. Parameters of physical fitness were evaluated at baseline, end-of-study, and, in the EXE group, also during the study period, in order to adjust training loads [18,19,24]. Assessment of cardio-respiratory fitness consisted of a sub-maximal VO2max test, i.e. at 80% of the predicted maximal heart rate, performed at the treadmill with direct measurement of oxygen consumption using a gas exchange analyzer (FitMate, Cosmed, Rome, Italy).
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This paper is dedicated to the memory of Umberto Di Mario (1948–2004). His warmth and intellectual curiosity were inspirational to all of us.
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A complete list of the members of the IDES Research Group and their professional affiliations can be found in Appendix A.