Status:
COMPLETED
Exercise Program Combined or Not With Nutritional intErvention in Adults With tyPe 2 Diabetes
Lead Sponsor:
Institut de Recherches Cliniques de Montreal
Conditions:
Overweight
Obesity
Eligibility:
All Genders
30-75 years
Phase:
NA
Brief Summary
Inactivity and excess energy consumption are leading causes of obesity and type 2 diabetes which are associated with increased cardio-metabolic risk. In order to reduce the cardiovascular risk associa...
Detailed Description
Type 2 diabetes is mainly caused by excess body weight due to lack of physical activity and high amount of calories consumption. Individuals with type 2 diabetes demonstrated increased risk of cardiov...
Eligibility Criteria
Inclusion
- Body mass index (BMI) 27-40 kg/m2
- Type 2 diabetes diagnosed since at least 3 months
- High risk of cardiovascular disease : Framingham global cardiovascular risk score for 10 years \> 15% or 2 or more of the following risk factors: age \> 50years, dyslipidemia or treatment, high blood pressure or treatment, pathologic microalbuminuria or established proteinuria, currently smoking, family history of early cardiovascular disease (\< 60 years), inactivity or high waist circumference according to IDF criteria
- HbA1c : 6.0-10.0%
- Stable weight for last 3 months (±3kg) reported or documented
- Stable treatment for diabetes. 4 weeks: blood pressure and dyslipidemia medications. 3 months: glitazones and weight loss drugs the treatment that will be maintained at the same dose during the study; insulin will have been introduced since 4 months at least and previous month dose should be stable defined as a 10% variation or less of total daily units.
Exclusion
- Pregnancy, breastfeeding
- Type 1 diabetes
- Secondary diabetes (e.g cystic fibrosis, steroid induced, etc.)
- Recurrent, hypoglycemia without precursor signs or severe hypoglycemia occurred ≥ 2 times for last 12 months
- Renal failure , creatinine clearance \< 40 ml/min (MDRD)
- Severe retinopathy or neuropathy that can contra-indicate exercise or expose patient to high risk of complications (e.g wound)
- NYHA classification class III or IV of cardiac insufficiency
- Established coronaropathy
- Non stable ventricular or supra-ventricular arrythmia
- Severe limb atherosclerosis or previous amputation
- Recent (\< 12 months) diagnosis of cancer excepted thyroid and skin
- Major mental disease
- Drugs with established effects on weigh such as megace®
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2016
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT01186952
Start Date
September 1 2010
End Date
April 1 2016
Last Update
April 19 2016
Active Locations (1)
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1
Institut de recherches cliniques de Montréal (IRCM)
Montreal, Quebec, Canada, H2W 1R7