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

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ClinicalTrials.gov Identifier: NCT01264809
Recruitment Status : Unknown
Verified December 2010 by University Hospital Center of Martinique.
Recruitment status was:  Not yet recruiting
First Posted : December 22, 2010
Last Update Posted : December 22, 2010
Sponsor:
Collaborator:
Clinique Antilles-Guyane
Information provided by:
University Hospital Center of Martinique

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Behavioral: Specific consultation for physical activity counseling Behavioral: Consultation for physical activity counseling Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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?
Study Start Date : March 2011
Estimated Primary Completion Date : March 2013
Estimated Study Completion Date : March 2013

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U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Benefits obtained after the physical activity counseling [ Time Frame: 6 months ]

    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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
University Hospital Center of Martinique
Clinique Antilles-Guyane
Investigators
Principal Investigator: Cédric FAGOUR, MD CHU de Fort-de-France
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ( Other Identifier: Afssaps- French Health Products Safety Agency )
First Posted: December 22, 2010    Key Record Dates
Last Update Posted: December 22, 2010
Last Verified: December 2010

Keywords provided by University Hospital Center of Martinique:
diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases