Effects of 3 Months of Supervised Exercise Training

Type 2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01349166
• Other study ID #: CHU-0088
• Status: Active, not recruiting
• Phase: N/A
• First received: February 3, 2011
• Last updated: May 5, 2011
• Start date: February 2008
• Est. completion date: February 2012

Study information

• Verified date: May 2011
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 45
• Est. completion date: February 2012
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years to 65 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Glucose Intolerance
• Overweight/Obesity
• Sedentarity
• Type 2 Diabetes

Intervention

Behavioral:
• Behavior: Supervised physical training
protocol designed to evaluate effects of physical activity on cardiometabolic and inflammatory biomarkers according to glucose tolerance

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	Centre de Recherche en Nutrition Humaine d'Auvergne

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	supervised physical training on cardiometabolic and inflammatory biomarkers		after 3 months	Yes
Secondary	relationships between cortisol secretion and the postprandial inflammatory responses depending on the level of glucose tolerance		after 3 months	Yes