Exercise Consultation for Type 2 Diabetes Patients in Real Life

Diabetes Mellitus, Type 2 Clinical Trial

— APDT 2  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01264809
• Other study ID #: 09/B/07
• Secondary ID: 2010-A00450-39
• Status: Not yet recruiting
• Phase: N/A
• First received: December 20, 2010
• Last updated: December 21, 2010
• Start date: March 2011
• Est. completion date: March 2013

Study information

• Verified date: December 2010
• Source: Centre Hospitalier Universitaire de Fort-de-France
• Contact: Jocelyne CRASPAG
• Phone: (0)596592698
• Email: jocelyne.craspag[@]chu-fortdefrance.fr
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

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

Locations

Country	Name	City	State
France	CHU de Fort-de-France- Hôpital Pierre Zobda Quitman	Fort-de-France	Martinique
France	CHU de Bordeaux - Hôpital Haut Lévêque	Pessac

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Fort-de-France	Clinique Antilles-Guyane

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		3 months	Yes
Secondary	Benefits obtained after the physical activity counseling	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	6 months	Yes