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ClinicalTrials.gov ID

NCT01264809

Lead Sponsor

University Hospital Center of MartiniqueOTHER

Overall Status

Unknown status

Study Type

Interventional

Phase

Not Applicable

Enrollment

80Estimated

Last Update Posted

Dec 22, 2010Estimated

Start Date

Mar 2011

Primary Completion Date

Mar 2013Estimated

Completion Date

Mar 2013Estimated

Official Title

Does Exercise Consultation Have a Realistic Chance of Increasing the Physical Activity Level of Type 2 Diabetes Patients in Real Life?

Brief Summary

The prevalence of type 2 diabetes is high and expected to increase dramatically in worldwide, in France and especially in the French West Indies.This chronic disease is associated with premature mortality and various debilitating complications which can be prevented by optimal control of glycaemia, blood pressure and lipids. Diabetes management includes lifestyle modification and medication. Despite numerous studies supporting the benefits of frequent physical activity for people with Type 2 diabetes, an estimated 60±80% of this population remain sedentary. Promotion of physical activity in current diabetes care seems to be inadequate.

The aim of this randomized controlled trial is to evaluate the medium-term effectiveness (after 3 and 6months) of exercise consultation in promoting physical activity in outpatients with Type 2 diabetes.

• Diabetes Mellitus, Type 2

• Specific consultation for physical activity counseling
• Consultation for physical activity counseling

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• Type 2 DM diagnosed within 10 years prior the inclusion

• 18-70 years old

• Signed written informed consent

• Diabetes treatment regimens :

  • diet only
  • oral antidiabetic drug
  • oral antidiabetic drugs with long acting insulin analog
  • oral antidiabetic drugs with GLP 1 analog

Exclusion Criteria:

• Minors
• Patients with concurrent medical conditions preventing exercise
• Pregnancy or intention to become pregnant during the study
• Inability to read and write French
• History of participating in our education program during the past two years
• Usual sporty activities
• Change in diabetes treatment during the three months prior to study enrollment
• No written informed consent

Primary Purpose

Health Services Research

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

University Hospital Center of MartiniqueOTHER

Collaborators

Clinique Antilles-GuyaneOTHER

vincent.rigalleau@chu-bordeaux.fr(0)556795679 ext. +33