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

Primary Purpose

Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Type of physical activity (resistance, endurance)
Restrictive diet
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Metabolic Syndrome focused on measuring Metabolic syndrome, exercise training, abdominal fat mass, endothelial function, diastolic function

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • CHU Clermont-Ferrand

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 9, 2009
Last Updated
July 4, 2014
Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Fondation Coeur et Artères
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1. Study Identification

Unique Protocol Identification Number
NCT00917917
Brief Title
Effect of Physical Activity and Diet on the Treatment of Metabolic Syndrome
Official 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.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Fondation Coeur et Artères

4. Oversight

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
Keywords
Metabolic syndrome, exercise training, abdominal fat mass, endothelial function, diastolic function

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Type of physical activity (resistance, endurance)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Restrictive diet
Intervention Description
All subjects will have the same restrictive diet (500- 700 kcal/d).
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruno Lesourd, MD
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
29866368
Citation
Vinet A, Obert P, Courteix D, Chapier R, Lesourd B, Verney J, Dutheil F, Walther G. Different modalities of exercise improve macrovascular function but not microvascular function in metabolic syndrome: The RESOLVE randomized trial. Int J Cardiol. 2018 Sep 15;267:165-170. doi: 10.1016/j.ijcard.2018.05.073. Epub 2018 May 23.
Results Reference
derived
PubMed Identifier
28416496
Citation
Lanhers C, Walther G, Chapier R, Lesourd B, Naughton G, Pereira B, Duclos M, Vinet A, Obert P, Courteix D, Dutheil F. Long-term cost reduction of routine medications following a residential programme combining physical activity and nutrition in the treatment of type 2 diabetes: a prospective cohort study. BMJ Open. 2017 Apr 16;7(4):e013763. doi: 10.1136/bmjopen-2016-013763.
Results Reference
derived
PubMed Identifier
27856807
Citation
Boudet G, Walther G, Courteix D, Obert P, Lesourd B, Pereira B, Chapier R, Vinet A, Chamoux A, Naughton G, Poirier P, Dutheil F. Paradoxical dissociation between heart rate and heart rate variability following different modalities of exercise in individuals with metabolic syndrome: The RESOLVE study. Eur J Prev Cardiol. 2017 Feb;24(3):281-296. doi: 10.1177/2047487316679523. Epub 2016 Nov 19.
Results Reference
derived
PubMed Identifier
26376093
Citation
Courteix D, Valente-dos-Santos J, Ferry B, Lac G, Lesourd B, Chapier R, Naughton G, Marceau G, Joao Coelho-e-Silva M, Vinet A, Walther G, Obert P, Dutheil F. Multilevel Approach of a 1-Year Program of Dietary and Exercise Interventions on Bone Mineral Content and Density in Metabolic Syndrome--the RESOLVE Randomized Controlled Trial. PLoS One. 2015 Sep 16;10(9):e0136491. doi: 10.1371/journal.pone.0136491. eCollection 2015. Erratum In: PLoS One. 2015;10(10):e0140307.
Results Reference
derived
PubMed Identifier
25657309
Citation
Walther G, Obert P, Dutheil F, Chapier R, Lesourd B, Naughton G, Courteix D, Vinet A. Metabolic syndrome individuals with and without type 2 diabetes mellitus present generalized vascular dysfunction: cross-sectional study. Arterioscler Thromb Vasc Biol. 2015 Apr;35(4):1022-9. doi: 10.1161/ATVBAHA.114.304591. Epub 2015 Feb 5.
Results Reference
derived
PubMed Identifier
25407698
Citation
Serrano-Ferrer J, Walther G, Crendal E, Vinet A, Dutheil F, Naughton G, Lesourd B, Chapier R, Courteix D, Obert P. Right ventricle free wall mechanics in metabolic syndrome without type-2 diabetes: effects of a 3-month lifestyle intervention program. Cardiovasc Diabetol. 2014 Aug 3;13:116. doi: 10.1186/s12933-014-0116-9.
Results Reference
derived
PubMed Identifier
25353072
Citation
Vinet A, Obert P, Dutheil F, Diagne L, Chapier R, Lesourd B, Courteix D, Walther G. Impact of a lifestyle program on vascular insulin resistance in metabolic syndrome subjects: the RESOLVE study. J Clin Endocrinol Metab. 2015 Feb;100(2):442-50. doi: 10.1210/jc.2014-2704. Epub 2014 Oct 29.
Results Reference
derived
PubMed Identifier
25015177
Citation
Dutheil F, Walther G, Chapier R, Mnatzaganian G, Lesourd B, Naughton G, Verney J, Fogli A, Sapin V, Duclos M, Vinet A, Obert P, Courteix D, Lac G. Atherogenic subfractions of lipoproteins in the treatment of metabolic syndrome by physical activity and diet - the RESOLVE trial. Lipids Health Dis. 2014 Jul 11;13:112. doi: 10.1186/1476-511X-13-112.
Results Reference
derived
PubMed Identifier
23714599
Citation
Dutheil F, Lac G, Lesourd B, Chapier R, Walther G, Vinet A, Sapin V, Verney J, Ouchchane L, Duclos M, Obert P, Courteix D. Different modalities of exercise to reduce visceral fat mass and cardiovascular risk in metabolic syndrome: the RESOLVE randomized trial. Int J Cardiol. 2013 Oct 9;168(4):3634-42. doi: 10.1016/j.ijcard.2013.05.012. Epub 2013 May 25.
Results Reference
derived

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

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