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Exercise Consultation for Type 2 Diabetes Patients in Real Life

NCT ID: NCT01264809

Last Updated: 2010-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2013-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Keywords

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diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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A : immediate physical activity counseling

Participants randomized in the experimental group (group A) will receive physical activity counseling during a one-to-one consultation at both baseline and 3 months.

Group Type EXPERIMENTAL

Specific consultation for physical activity counseling

Intervention Type BEHAVIORAL

Specific consultation

B : later physical activity counseling

Exercise consultation will be realised only at 3 months in the control group(group B). Furthermore, patients of group B will not received any physical activity counseling at baseline.

Group Type ACTIVE_COMPARATOR

Consultation for physical activity counseling

Intervention Type BEHAVIORAL

Specific consultation

Interventions

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Specific consultation for physical activity counseling

Specific consultation

Intervention Type BEHAVIORAL

Consultation for physical activity counseling

Specific consultation

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Clinique Antilles-Guyane

OTHER

Sponsor Role collaborator

University Hospital Center of Martinique

OTHER

Sponsor Role lead

Responsible Party

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CHU de Fort-de-France

Principal Investigators

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Cédric FAGOUR, MD

Role: PRINCIPAL_INVESTIGATOR

CHU de Fort-de-France

Locations

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CHU de Fort-de-France- Hôpital Pierre Zobda Quitman

Fort-de-France, Martinique, France

Site Status

CHU de Bordeaux - Hôpital Haut Lévêque

Pessac, , France

Site Status

Countries

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France

Central Contacts

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Jocelyne CRASPAG

Role: CONTACT

Phone: (0)596592698

Email: [email protected]

Mickaëlle ROSE

Role: CONTACT

Phone: (0) 596592698

Email: [email protected]

Facility Contacts

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Cédric FAGOUR, MD

Role: primary

Miguelle ROSETTE-NARECE, MD

Role: backup

Vincent RIGALLEAU, MD-PhD

Role: primary

Henri GIN, MD-PhD

Role: backup

Other Identifiers

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2010-A00450-39

Identifier Type: OTHER

Identifier Source: secondary_id

09/B/07

Identifier Type: -

Identifier Source: org_study_id