Diabetes Mellitus, Type 2APDT 2NCT01264809
Exercise Consultation for Type 2 Diabetes Patients in Real Life
A study testing Specific consultation for physical activity counseling and Consultation for physical activity counseling in people with Diabetes Mellitus, Type 2, run by University Hospital Center of Martinique at 2 sites in France.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Specific consultation for physical activity counseling and Consultation for physical activity counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesFrance
- Study dates
- Mar 2011to Mar 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU de Fort-de-France- Hôpital Pierre Zobda Quitman
Fort-de-France, Martinique, 97261
Cédric FAGOUR, MD, (0)596552241 ext. +596, cedric.fagour@chu-fortdefrance.fr
Miguelle ROSETTE-NARECE, MD, (0)596552241 ext. +596, miguelle.rosette-narece@chu-fortdefrance.fr
CHU de Bordeaux - Hôpital Haut Lévêque
Pessac, 33604
Vincent RIGALLEAU, MD-PhD, (0)556795679 ext. +33, vincent.rigalleau@chu-bordeaux.fr
Henri GIN, MD-PhD, (0)556795679 ext. +33, henri.gin@chu-bordeaux.fr
About this study
Official title: Does Exercise Consultation Have a Realistic Chance of Increasing the Physical Activity Level of Type 2 Diabetes Patients in Real Life?
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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Specific consultation for physical activity counseling, Consultation for physical activity counseling
- Keywords
- diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specific consultation for physical activity counselingBehavioural
Specific consultation
Consultation for physical activity counselingBehavioural
Specific consultation
| Study group | Role | What they receive |
|---|---|---|
| A : immediate physical activity counseling | Experimental | 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. Receives: Behavioral: Specific consultation for physical activity counseling |
| B : later physical activity counseling | Active comparator | 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. Receives: Behavioral: Consultation for physical activity counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (1)
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2010 (estimated)
- Study startMar 2011
- Primary completionMar 2013 (estimated)
- Study completionMar 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Center of Martinique
- Sponsor type
- University, hospital or other
- Collaborators
- Clinique Antilles-Guyane
- Investigators
- Cédric FAGOUR, MD, Principal investigator, CHU de Fort-de-France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01264809
- Sponsor's protocol ID
- 09/B/07
- Other IDs
- 2010-A00450-39
- Acronym
- APDT 2
- Status last verified
- Dec 2010
- First submitted
- 20 Dec 2010
- Last updated
- 22 Dec 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Exercise Consultation Have a Realistic Chance of Increasing the Physical Activity Level of Type 2 Diabetes Patients in Real Life?
- ClinicalTrials.gov ID
- NCT01264809
- Acronym / sponsor ID
- APDT 2 / 09/B/07
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital Center of MartiniqueUniversity, hospital or other
- Collaborators
- Clinique Antilles-Guyane
- Study start
- Mar 2011
- Primary completion
- Mar 2013 (estimated)
- Study completion
- Mar 2013 (estimated)
- First posted
- 22 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A : immediate physical activity counseling | Experimental | Behavioral: Specific consultation for physical activity counselingParticipants randomized in the experimental group (group A) will receive physical activity counseling during a one-to-one consultation at both baseline and 3 months. |
| B : later physical activity counseling | Active comparator | Behavioral: Consultation for physical activity counselingExercise 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Type 2 DM diagnosed within 10 years prior the inclusion
- 18-70 years old
- Signed written informed consent
- Diabetes treatment regimens :
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Specific consultation for physical activity counselingSpecific consultation | Behavioural | A : immediate physical activity counseling |
| Consultation for physical activity counselingSpecific consultation | Behavioural | B : later physical activity counseling |
Primary outcome
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
1 secondary outcome
Benefits obtained after the physical activity counseling
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cédric FAGOUR, MD principal investigator
CHU de Fort-de-France
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Specific consultation for physical activity counseling and Consultation for physical activity counseling in people with Diabetes Mellitus, Type 2, run by University Hospital Center of Martinique at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jocelyne CRASPAG ((0)596592698 ext. +596, jocelyne.craspag@chu-fortdefrance.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2010.