Back to resultsEffects of 3 Months of Supervised Exercise Training
Primary Purpose
Overweight/Obesity, Glucose Intolerance, Type 2 Diabetes
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Behavior: Supervised physical training
Sponsored by
About this trial
This is an interventional basic science trial for Overweight/Obesity focused on measuring Obesity, Type 2 diabetes, glucose intolerance, Physical Activity, Inflammation, HPA axis, Cytokines
Eligibility Criteria
Inclusion Criteria:
- Male Caucasian Adults between 30 and 65 years old Sedentary criteria based on the determination of fasting glucose (WHO 1999):
- normal if fasting plasma glucose (FPG) <1.10 g / l
- diabetes if fasting glucose> 1.26 g / l (7 mmol / l) twice
- nondiabetic fasting hyperglycemia: 1.10 g / l ≤ FPG ≤ 1.26 g / l
- glucose intolerance : if plasma glucose at 120 minutes during the OGTT (75g) is between 1.40 g / l and 2 g/ l.
Body mass index 25 BMI 35kg/m2 Affiliated to National Health Insurance Subject giving his written informed consent Subject considered as normal after clinical examination and medical questionnaire
Exclusion Criteria:
- - drugs that interfere with the parameters determined
- diabetic treated with insulin, glitazones or glinides
- eating disorders like bulimia and vomiting
- special diet, vegan or vegetarian
- autoimmune disease or inflammatory progressive desease requiring prolonged treatment
- regular physical activity (> 1 hour of physical activity per week for at least 6 months)
- smoking (> 5 cigarettes / day)
- weight change greater than 5% of the total weight in the 3 months preceding the study
- contra-indication to physical activity
- chronic pathologies: cancer, inflammatory, cardiac, pulmonary, renal, gastrointestinal or liver diseases
- Being in exclusion on the National Volunteers Data file
- No one under guardianship or not subject to social security.
- Being under someone's supervision
- Subjects deprived of their liberty by judicial or administrative.
- Refusal to sign the information sheet and written consent for particip
Sites / Locations
Outcomes
Primary Outcome Measures
supervised physical training on cardiometabolic and inflammatory biomarkers
Secondary Outcome Measures
relationships between cortisol secretion and the postprandial inflammatory responses depending on the level of glucose tolerance
Full Information
NCT ID
NCT01349166
First Posted
February 3, 2011
Last Updated
May 5, 2011
Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Centre de Recherche en Nutrition Humaine d'Auvergne
1. Study Identification
Unique Protocol Identification Number
NCT01349166
Brief Title
Effects of 3 Months of Supervised Exercise Training
Official Title
Effects of 3 Months of Supervised Exercise Training on Cardiometabolic and Inflammatory Biomarkers According to Glucose Tolerance (Normal, Intolerance and Type 2 Diabetes): Measures in Unstimulated and Stimulated Conditions
Study Type
Interventional
2. Study Status
Record Verification Date
May 2011
Overall Recruitment Status
Unknown status
Study Start Date
February 2008 (undefined)
Primary Completion Date
August 2011 (Anticipated)
Study Completion Date
February 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Centre de Recherche en Nutrition Humaine d'Auvergne
4. Oversight
5. Study Description
Brief Summary
The incidence of type 2 diabetes is increasing worldwide. Because of cardiovascular morbidity and mortality associated with type 2 diabetes, it is imperative to propose methods of prevention and this in early stage of abnormal glucose metabolism.
This study will assess the beneficial effects of physical activity (acute and chronic effects) (the subjects being their own controls) on cardiometabolic and inflammatory biomarkers in 3 conditions : unstimulated (fasting and resting conditions) and stimulated conditions: postprandial response to a standardized meal preceded or not by an exercise bout.
The investigators hypothesized that an acute bout of exercise will decrease the postprandial inflammatory response to a standardized meal and that this effect of exercise will be increased after 3 months of exercise training.
Detailed Description
This is a prospective study over 4 months, open, nonrandomized. 45 overweight or obese male subjects will complete 3 experimental sessions (0700-1400h) before and after 3 months of supervised physical training. During a first session, subjects will remain inactive and fasted (basal conditions). During the second session a standardized meal will be offered (postprandial response to a standardized meal). The third session will consist in the realization of an exercise bout (60min at 60%VO2 max) followed by a standardized meal (same meal that the previous day).
Several blood (catheter), salivary and urinary samples will be collected during the 3 sessions, throughout the experimental day.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight/Obesity, Glucose Intolerance, Type 2 Diabetes, Sedentarity
Keywords
Obesity, Type 2 diabetes, glucose intolerance, Physical Activity, Inflammation, HPA axis, Cytokines
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Behavior: Supervised physical training
Intervention Description
protocol designed to evaluate effects of physical activity on cardiometabolic and inflammatory biomarkers according to glucose tolerance
Primary Outcome Measure Information:
Title
supervised physical training on cardiometabolic and inflammatory biomarkers
Time Frame
after 3 months
Secondary Outcome Measure Information:
Title
relationships between cortisol secretion and the postprandial inflammatory responses depending on the level of glucose tolerance
Time Frame
after 3 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male Caucasian Adults between 30 and 65 years old Sedentary criteria based on the determination of fasting glucose (WHO 1999):
normal if fasting plasma glucose (FPG) <1.10 g / l
diabetes if fasting glucose> 1.26 g / l (7 mmol / l) twice
nondiabetic fasting hyperglycemia: 1.10 g / l ≤ FPG ≤ 1.26 g / l
glucose intolerance : if plasma glucose at 120 minutes during the OGTT (75g) is between 1.40 g / l and 2 g/ l.
Body mass index 25 BMI 35kg/m2 Affiliated to National Health Insurance Subject giving his written informed consent Subject considered as normal after clinical examination and medical questionnaire
Exclusion Criteria:
- drugs that interfere with the parameters determined
diabetic treated with insulin, glitazones or glinides
eating disorders like bulimia and vomiting
special diet, vegan or vegetarian
autoimmune disease or inflammatory progressive desease requiring prolonged treatment
regular physical activity (> 1 hour of physical activity per week for at least 6 months)
smoking (> 5 cigarettes / day)
weight change greater than 5% of the total weight in the 3 months preceding the study
contra-indication to physical activity
chronic pathologies: cancer, inflammatory, cardiac, pulmonary, renal, gastrointestinal or liver diseases
Being in exclusion on the National Volunteers Data file
No one under guardianship or not subject to social security.
Being under someone's supervision
Subjects deprived of their liberty by judicial or administrative.
Refusal to sign the information sheet and written consent for particip
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martine DUCLOS
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Effects of 3 Months of Supervised Exercise Training
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