Italian diabetes exercise study: a 20-center randomised controlled clinical trial designed to evaluate the safety and efficacy of intensive lifestyle intervention on controllable cardiovascular risk factors in type 2 diabetic subjects with metabolic syndrome

Completed

• Conditions: Diabetes and metabolic syndrome.; Nutritional, Metabolic, Endocrine; Diabetes

• Registration Number: ISRCTN04252749
• Lead Sponsor: Metabolic Fitness Association (Italy)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09-19
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

Type 2 diabetes patients with metabolic syndrome, age from 40 to 80 years, duration of diabetes >1 year, body mass index (BMI) =27, =40, sedentary for at least six months, able to walk without assistance and eligible after cardiovascular algorithm evaluation. Of these, only those who give written informed consent.

Exclusion Criteria

Patients having at least one of the following conditions will be excluded from the study:
1. A history or evidence on physical examination of significant central nervous system dysfunction (i.e. hemiparesis, myelopathy, cerebellar ataxia)
2. Significant musculoskeletal deformity (i.e. amputation, scoliosis, abnormality of range of motion [ROM]) that would prevent participation (<90° of humeral abduction, inability to grip, <10° of combined ankle inversion/eversion)
3. Lower extremity arthritis or pain that limits exercise
4. History or clinical evidence of severe cardiovascular diseases that limit or contraindicate the exercise
5. A history or evidence on physical examination of vestibular dysfunction
6. A history of angina or angina equivalent symptoms (i.e. nausea, diaphoresis, shortness of breath with exercise)
7. Symptomatic postural hypotension defined as a fall in blood pressure (i.e. >20 mmHg for systolic or >10 mmHg for diastolic blood pressure) in response to postural change, from supine to standing
8. A history or evidence on physical examination of plantar skin pressure ulcer

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The Primary Endpoint will be to determine the numbers of patients within two groups that after 12 months achieve a % rate reduction of the following parameters: Hba1c = =?15%, Cholesterol - low density lipoprotein (LDL) = =?15%, Triglyceride = =?15%, Cholesterol - high density lipoprotein (HDL) = =+15%, Blood Pressure = =?5 mmHg x diastolic and systolic, BMI = BMI reduction =7% for patients with BMI =27, Waist =-10%

Secondary Outcome Measures

Name	Time	Method
Secondary endpoints are the numbers of patients within two groups that after 12 months, achieve set standards of<br>1. Well-being<br>2. Dose/response between volume and intensity of exercise training and controllable cardiovascular risk factors<br>3. Impact of Exercise training on: coagulation and inflammation markers, endothelial function<br>4. The frequency of medication for three classes of drugs (hypolipemic, hypoglycemic, and antihypertensive therapies)<br>5. 10-year coronary heart disease (CHD) risk (as calculated from Framingham risk tables)<br>6. Cost analysis: Direct medical costs and Direct and Indirect social costs