Exercise Consultation for Type 2 Diabetes Patients in Real Life (APDT 2)

The recruitment status of this study is unknown because the information has not been verified recently.

Verified December 2010 by Centre Hospitalier Universitaire de Fort-de-France.
Recruitment status was Not yet recruiting

Sponsor:

Collaborator:

Clinique Antilles-Guyane

Information provided by:

Centre Hospitalier Universitaire de Fort-de-France

ClinicalTrials.gov Identifier:

NCT01264809

First received: December 20, 2010

Last updated: December 21, 2010

Last verified: December 2010

History of Changes

Purpose

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.

Condition	Intervention
Diabetes Mellitus, Type 2	Behavioral: Specific consultation for physical activity counseling Behavioral: Consultation for physical activity counseling


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Health Services Research
Official Title:	Does Exercise Consultation Have a Realistic Chance of Increasing the Physical Activity Level of Type 2 Diabetes Patients in Real Life?

Resource links provided by NLM:

MedlinePlus related topics: Exercise and Physical Fitness Health Checkup

U.S. FDA Resources

Further study details as provided by Centre Hospitalier Universitaire de Fort-de-France:

Primary Outcome Measures:

Change in daily physical activity measured by SenseWear Pro3 Armband®. Participants were instructed to wear the monitor for seven days during all waking hours except bathing. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Benefits obtained after the physical activity counseling [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
The secondary outcome of this study is to compare the benefits obtained 3 and 6 mounths after the physical activity counseling on :
- Quality of life scores
- Anthropometric measurement and Body Mass Index (BMI)
- Body composition measurement
- Hand grip strength
- Blood pressure
- Glycaemic control and cholesterol
- Medication


Estimated Enrollment:	80
Study Start Date:	March 2011
Estimated Study Completion Date:	March 2013
Estimated Primary Completion Date:	March 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 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.	Behavioral: Specific consultation for physical activity counseling Specific consultation
Active Comparator: 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.	Behavioral: Consultation for physical activity counseling Specific consultation

Eligibility


Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01264809

Contacts


Contact: Jocelyne CRASPAG	(0)596592698 ext +596	jocelyne.craspag@chu-fortdefrance.fr
Contact: Mickaëlle ROSE	(0) 596592698 ext +596	mickaelle.rose@chu-fortdefrance.fr

Locations


France
CHU de Fort-de-France- Hôpital Pierre Zobda Quitman	Not yet recruiting
Fort-de-France, Martinique, France, 97261
Contact: Cédric FAGOUR, MD (0)596552241 ext +596 cedric.fagour@chu-fortdefrance.fr
Contact: Miguelle ROSETTE-NARECE, MD (0)596552241 ext +596 miguelle.rosette-narece@chu-fortdefrance.fr
Principal Investigator: Cedric FAGOUR, MD
Sub-Investigator: Miguelle ROSETTE-NARECE, MD
CHU de Bordeaux - Hôpital Haut Lévêque	Not yet recruiting
Pessac, France, 33604
Contact: Vincent RIGALLEAU, MD-PhD (0)556795679 ext +33 vincent.rigalleau@chu-bordeaux.fr
Contact: Henri GIN, MD-PhD (0)556795679 ext +33 henri.gin@chu-bordeaux.fr
Principal Investigator: Vincent RIGALLEAU, MD-PhD
Sub-Investigator: Henri GIN, MD-PhD

Sponsors and Collaborators

Centre Hospitalier Universitaire de Fort-de-France

Clinique Antilles-Guyane

Investigators


Principal Investigator:	Cédric FAGOUR, MD	CHU de Fort-de-France

More Information

No publications provided


Responsible Party:	FAGOUR Cédric, CHU de Fort-de-France
ClinicalTrials.gov Identifier:	NCT01264809 History of Changes
Other Study ID Numbers:	09/B/07, 2010-A00450-39
Study First Received:	December 20, 2010
Last Updated:	December 21, 2010
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Hospitalier Universitaire de Fort-de-France:


diabetes

Additional relevant MeSH terms:


Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases

ClinicalTrials.gov processed this record on March 03, 2015

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