Effects of 3 Months of Supervised Exercise Training

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by University Hospital, Clermont-Ferrand.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Centre de Recherche en Nutrition Humaine d'Auvergne
Information provided by:
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT01349166
First received: February 3, 2011
Last updated: May 5, 2011
Last verified: May 2011
  Purpose

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.


Condition Intervention
Overweight/Obesity
Glucose Intolerance
Type 2 Diabetes
Sedentarity
Behavioral: Behavior: Supervised physical training

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
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

Resource links provided by NLM:


Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • supervised physical training on cardiometabolic and inflammatory biomarkers [ Time Frame: after 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • relationships between cortisol secretion and the postprandial inflammatory responses depending on the level of glucose tolerance [ Time Frame: after 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 45
Study Start Date: February 2008
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Behavior: Supervised physical training
    protocol designed to evaluate effects of physical activity on cardiometabolic and inflammatory biomarkers according to glucose tolerance
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.

  Eligibility

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01349166

Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Centre de Recherche en Nutrition Humaine d'Auvergne
Investigators
Principal Investigator: Martine DUCLOS University Hospital, Clermont-Ferrand
  More Information

No publications provided

Responsible Party: Patrick LACARIN, CHU Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01349166     History of Changes
Other Study ID Numbers: CHU-0088
Study First Received: February 3, 2011
Last Updated: May 5, 2011
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Clermont-Ferrand:
Obesity
Type 2 diabetes
glucose intolerance
Physical Activity
Inflammation
HPA axis
Cytokines

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Obesity
Glucose Intolerance
Overweight
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms
Hyperglycemia

ClinicalTrials.gov processed this record on July 22, 2014