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

July 4, 2014 updated by: University Hospital, Clermont-Ferrand

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63003
        • Chu Clermont-Ferrand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
at Day 0, 21 and at 3, 6 and 12 months using abdominal circumference and DXA

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
at day 0, 21 and at month 3, 6 and 12.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Collaborators

Fondation Coeur et Artères

Investigators

  • Principal Investigator: Bruno Lesourd, MD, University Hospital, Clermont-Ferrand

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

June 9, 2009

First Submitted That Met QC Criteria

June 10, 2009

First Posted (Estimate)

June 11, 2009

Study Record Updates

Last Update Posted (Estimate)

July 8, 2014

Last Update Submitted That Met QC Criteria

July 4, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHU-0053

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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