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.
OBJECTIVE
The IDES is a prospective Italian multicentre randomized controlled trial to evaluate the efficacy of an intensive lifestyle intervention on modifiable cardiovascular disease (CVD) risk factors in a large cohort of people with type 2 diabetes and the metabolic syndrome.


RESULTS
We recruited 606 subjects with type 2 diabetes and waist circumference >94 cm (M) and >80 cm (F), plus >1 other metabolic syndrome trait (IDF criteria) for both sexes, aged 40-75 years, BMI 27-40 kg/m(2), diabetes duration >1 year with a sedentary lifestyle of >6 months. Patients were randomized into two groups: a control group, receiving conventional care including exercise counselling and an intervention group, treated with a mixed (aerobic and resistance) exercise programme (150 min/week) prescribed and supervised for 12 months. Primary outcome is HbA1c reduction. Secondary outcomes include other traditional and non-traditional risk factors and their relationship to exercise volume/intensity and fitness; dosage of glucose, lipid and blood pressure-lowering drugs; global CVD 10-year risk; patient well-being; and costs.


CONCLUSIONS
This trial verifies whether a prescribed and supervised exercise programme, including both aerobic and resistance training, is more effective than conventional exercise counselling in reducing modifiable CVD risk factors in type 2 diabetic subjects with the metabolic syndrome.
Balducci
Stefano
S
Metabolic Fitness Association, Monterotondo, Rome, Italy. sbalducci@esinet.it
Zanuso
Silvano
S
Massarini
Massimo
M
Corigliano
Gerardo
G
Nicolucci
Antonio
A
Missori
Serena
S
Cavallo
Stefano
S
Cardelli
Patrizia
P
Alessi
Elena
E
Pugliese
Giuseppe
G
Fallucca
Francesco
F
D000328:Adult; D000368:Aged; D002318:Cardiovascular Diseases / Q000401:mortality / Q000517:prevention & control*; D003924:Diabetes Mellitus, Type 2 / Q000628:therapy*; D015444:Exercise; D005260:Female; D006801:Humans; D008019:Life Style; D008297:Male; D024821:Metabolic Syndrome / Q000628:therapy*; D008875:Middle Aged; D011446:Prospective Studies; D012107:Research Design; D012307:Risk Factors