This trial is active, not recruiting.

Conditions overweight/obesity, glucose intolerance, type 2 diabetes, sedentarity
Treatment behavior: supervised physical training
Sponsor University Hospital, Clermont-Ferrand
Collaborator Centre de Recherche en Nutrition Humaine d'Auvergne
Start date February 2008
End date August 2011
Trial size 45 participants
Trial identifier NCT01349166, CHU-0088


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model parallel assignment
Masking open label
Primary purpose basic science

Primary Outcomes

supervised physical training on cardiometabolic and inflammatory biomarkers
time frame: after 3 months

Secondary Outcomes

relationships between cortisol secretion and the postprandial inflammatory responses depending on the level of glucose tolerance
time frame: after 3 months

Eligibility Criteria

Male participants from 30 years up to 65 years old.

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

Additional Information

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
Principal investigator Martine DUCLOS
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2011.
Information provided to ClinicalTrials.gov by University Hospital, Clermont-Ferrand.