NCT01349166

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2008

Longer than P75 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

February 3, 2011

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 6, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

May 6, 2011

Status Verified

May 1, 2011

Enrollment Period

3.5 years

First QC Date

February 3, 2011

Last Update Submit

May 5, 2011

Conditions

Overweight/ObesityGlucose IntoleranceType 2 DiabetesSedentarity

Keywords

ObesityType 2 diabetesglucose intolerancePhysical ActivityInflammationHPA axisCytokines

Outcome Measures

Primary Outcomes (1)

  • supervised physical training on cardiometabolic and inflammatory biomarkers

    after 3 months

Secondary Outcomes (1)

  • relationships between cortisol secretion and the postprandial inflammatory responses depending on the level of glucose tolerance

    after 3 months

Interventions

Behavior: Supervised physical trainingBEHAVIORAL

protocol designed to evaluate effects of physical activity on cardiometabolic and inflammatory biomarkers according to glucose tolerance

Eligibility Criteria

Age30 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \- 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

OverweightObesityGlucose IntoleranceDiabetes Mellitus, Type 2Motor ActivityInflammation

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesDiabetes MellitusEndocrine System DiseasesBehaviorPathologic Processes

Study Officials

  • Martine DUCLOS

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 3, 2011

First Posted

May 6, 2011

Study Start

February 1, 2008

Primary Completion

August 1, 2011

Study Completion

February 1, 2012

Last Updated

May 6, 2011

Record last verified: 2011-05