Effect of Physical Activity and Diet on the Treatment of Metabolic Syndrome

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00917917
• Date of registration: 09/06/2009
• Prospective Registration: No
• Primary sponsor: University Hospital, Clermont-Ferrand
• Public title: Effect of Physical Activity and Diet on the Treatment of Metabolic Syndrome
• Scientific title: Role of Combined Intervention of Physical Activity and Nutrition in Metabolic Syndrome Treatment on Cardio-vascular Risk and Muscular- Skeletal Functions in Human Subject. Analysis of Patient's Compliance in Patient's Follow-up.
• Date of first enrolment: May 2009
• Target sample size: 150
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00917917
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
• Phase: N/A

Countries of recruitment

France

Contacts

• Name: Bruno Lesourd, MD
• Affiliation: University Hospital, Clermont-Ferrand

Key inclusion & exclusion criteria

Inclusion Criteria:

- 50-70 years old from both sexes

- with metabolic syndrome

- affiliated to a social security system

- able to practice maximal physical exercises based on VO2 max

- able to sign inform consent

Exclusion Criteria:

- recent (6 month) major health conditions and patients with recurrent health problems
(1 per year)

- patients who are not capable to perform VO2 max without abnormalities

- dyserection treated patients

- patients with insufficient comprehensive ability to feel questionnaire and/or to
change habits



Age minimum: 50 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Metabolic Syndrome

Intervention(s)

Behavioral: Type of physical activity (resistance, endurance)

Behavioral: Restrictive diet

Primary Outcome(s)

Decreased abdominal fat mass, measured after one year. Such measured will be done repetitively at Day 0, 21 and at 3, 6 and 12 months using abdominal circumference and DXA Decreased cardio-vascular risks [Time Frame: at Day 0, 21 and at 3, 6 and 12 months using abdominal circumference and DXA]

Secondary Outcome(s)

All the following measures will be done at day 0, 21 and at month 3, 6 and 12. Level of physical activities of each types Physical performances, Food intake and equilibrium Other Metabolic Syndrome inc [Time Frame: at day 0, 21 and at month 3, 6 and 12.]

Secondary ID(s)

CHU-0053

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Fondation Coeur et Artères