Effect of Physical Activity and Diet on the Treatment of Metabolic Syndrome
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      Metabolic syndrome has been defined as a group of associated risk factors for cardio-vascular
      diseases and diabetes. It is usually treated with an association of restrictive diet,
      physical exercise and drugs. Nevertheless the type of exercise associated to reduction in
      cardio-vascular risks is not yet fully defined. Long term effects of such hygienic-diet
      programs are of great importance since it is well-known that compliance to such treatment are
      of short duration, namely when subjects return in routine life. Metabolic syndrome volunteer
      subjects (n=90), aged 50 to 70 yrs will be randomly assigned to 3 groups of investigation.One
      group will perform mostly resistance activity, a second mainly endurance activity and the
      third one will be composed of subjects not exercising a lot. All subjects will have the same
      restrictive diet (500-700 kcal/d) After the initial training (3 weeks), they will return home
      with diet and physical program advises (personal compliance). They will be followed for one
      year (at 3, 6 and 12 months) Such a design may allow to find out the type of activity and
      power that are the best to reduce metabolic syndrome parameters and cardio-vascular risk
      factors.

      The primary outcome variable is the reduction in abdominal circumference, which is the main
      criteria of MS.
    

Detailed description: 
      The protocol is designed to determine which type of physical activity is the best to reduce
      metabolic syndrome parameters especially abdominal circumference.

      90 Metabolic syndrome (MS) Patients will be recruited by advertising and checked for MS
      criteria. They will have a VO2max test in order to be sure they can perform physical
      activities safely. After being checked, patients will have an eight day period to think about
      participation and to ask questions before signing consent. They have to feel 3
      questionnaires, one about regular physical activities, one about food intakes and a
      psychology one to measure reluctance to the program. After written informed consent obtained,
      patients will be randomly assigned to one of 3 groups of physical activity Group 1 will
      perform mostly resistance activities, group 2 mostly endurance activities, and group 3
      performing both activities at low level, serves as a control group for physical activities
      and also to determine the importance of food reduction and food equilibrium in the treatment.

      All subjects will have the same restrictive diet (500- 700 kcal/d). They will be followed for
      one year (at 3, 6 and 12 month), continuing at home the same program (diet and exercise
      training).

      30 healthy subjects will be recruited for cross-sectional comparison (They will not follow
      any intervention, but will have the same investigation, only once).

      Measured parameters Before and after the 3-week program and at 3, 6 and 12 months, the
      following measurements will be made Level of physical activities quantifying heart rate in
      each activity during the training 3 weeks and estimated thereafter on the same parameter.

      Physical capacities With the 6 minute walking test, Food intake and equilibrium measured by
      full week records before training, during training and monthly thereafter. They will be
      quantified by a trained dietician using the reference French Cidal tables.

      Metabolic syndrome factors Body composition including weight, height, abdominal
      circumference, total and torcular lean and total and abdominal fat mass measured by DXA
      Cardiac diastolic and systolic functions by means of standard, Tissue Doppler imaging and
      2D-strain echocardiogram Vascular structure function in conduit and resistance arteries and
      microvascular reactivity Biological parameters with glycemic control : insulinemia and glaced
      haemoglobin Inflammatory syndrome and related cytokines: CRP, 1GPA, IL-6, TNF-, Il-12 and
      IL-10 blood protein: Albumine and transthyretin Appetite hormone: Leptine, adiponectin,
      Gremlin and CCK osteocalcin, BASP and CTx

      Statical analysis Subject numbers were calculated from the results of a pilot. A statistical
      significance (p=0,05) may be reached with 22 subjects in group 1 and 2 for a difference of
      0,6 kg of abdominal fat mass.

      For cross-sectional comparison, healthy and MS subjects will be compared by unpaired Student
      test. The 3 groups of patients will be compared using a repeated measure ANOVA. If positive,
      a post-hoc test for mean comparison will be performed.

      A correlation matrix will analyse relationships between studied parameters. A principal
      component analysis will allow to determine the reciprocal weight of positive explicating
      factors.

      The study is done applying French and international regulations
    

Intervention name(s): Type of physical activity (resistance, endurance); Restrictive diet
Intervention type(s): Behavioral; Behavioral
Intervention description(s): To determine which type of physical activity is the best to reduce metabolic syndrome parameters especially abdominal circumference.
Group 1 will perform mostly resistance activities, group 2 mostly endurance activities, and Group 3 performing both activities at low level, serves as a control group for physical activities.; All subjects will have the same restrictive diet (500- 700 kcal/d).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Metabolic syndrome; exercise training; abdominal fat mass; endothelial function; diastolic function