AzTrials
AzTrials

NIDDMPhase 2NCT00234273

APAD2: Effects of Rehabilitation Programme in Adapted Physical Activity (APA) Among Type 2 Diabetics

A Phase 2 study testing Rehabilitation programme in Adapted Physical Activity (APA) and Therapeutic education primarily focused on dietary in people with NIDDM, run by University Hospital, Grenoble at 4 sites in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

The principal objective is to assess and analyze the effects of a six month programme in Adapted Physical Activity (APA) on physical activity, compliance, and insulin resistance among type 2 diabetics. Read more about this study

Who is it for?
Ages 40 years and olderHealthy volunteers can take part
Conditions the study is for
NIDDM
What is being tested?
Rehabilitation programme in Adapted Physical Activity (APA) and Therapeutic education primarily focused on dietary
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
4 sitesFrance
Study dates
Nov 2004to Jun 2008
Phase
Phase 2
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 40 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Type 2 diabetics
  • Age > 40
  • First education in the Education Diabetics Department of the University Hospital Grenoble
  • Sedentary patients
  • Hemoglobin A1c (HbA1c) > 7%
  • Body mass index (BMI) > 25
  • To be affiliated with disease assurance
  • To give written and informed consent

Who cannot join

  • Foot sore < six months
  • Renal disease - proteinuria stage
  • Contraindication for exercise
  • VO2 max > 120% Wassermann standard
  • Coronary pathology non-stabilization
  • Arteriopathy stage 2 non-compensation
  • Osteo-articular crippling problem
  • Geographically distant

Trial locations and contacts

4 sites in 1 country.

France4 sites

  • Department of Endocrinology, Diabetology and Nutrition

    Grenoble, Auvergne-Rhône-Alpes, 38000

  • Endocrinology, Diabetology and Nutrition - University Hospital of Grenoble

    Grenoble, Auvergne-Rhône-Alpes, 38000

  • Endocrinology, Diabetology and Nutrition Department - University Hospital of Grenoble

    Grenoble, 38000

  • HALIMI Serge

    Grenoble, 38000

Other trials in France

About this study

Official title: Effects Rehabilitation Programme in Adapted Physical Activity (APA) Among Type 2 Diabetics Persons

The principal objective is to assess and analyze the effects of a six month programme in Adapted Physical Activity (APA) on physical activity, compliance, and insulin resistance among type 2 diabetics.

Read the detailed description

Clinical trial with direct individual profit. Study phase 2. Study center: University Hospital Grenoble Principal investigator: Pr. Serge HALIMI Sponsor: University Hospital Grenoble

The principal objective is to assess and analyze the effects of a six month programme in Adapted Physical Activity (APA) on physical activity, compliance, and insulin resistance among type 2 diabetics.

Secondary objectives are to assess and analyze the effects of a six month programme in APA of:

  • arterial tension
  • weight, body composition and abdominal perimeter
  • quality of life
  • treatment dosage
  • number of hospitalisation thick a diabetes complication acute for one year and for each patient Compare two exercise's intensity: first lactate threshold (SL1) and crossover (PCGL).

Inclusion criteria:

  • type 2 diabetics
  • age > 40 years
  • first education in Education Diabetics Department of University Hospital Grenoble
  • sedentary patients
  • HbA1c > 7%-
  • BMI > 25
  • to be affiliate disease assurance
  • to give consent written and inform

Judgment criteria for physical activity compliance:

  • leisure time physical activity: Modifiable Activity Questionnaire
  • training note-book

Judgment criteria for resistance insulin:

  • Crossover (PCGL)
  • HOMA and FIRI index
  • HbA1c

Programme test: Rehabilitation programme in Adapted Physical Activity (APA)

Programme test period: 6 months

Study total period: 28 months

Study period for each patient: 18 months

Safety criteria: clinical compendium undesirable events

Conditions
NIDDM
Being tested
Rehabilitation programme in Adapted Physical Activity (APA), Therapeutic education primarily focused on dietary
Keywords
Adapted Physical Activity, Quality of life, cardiovascular risk, teaching, Directly Observed Therapy, Physical activity
Medical subject headings
Diabetes Mellitus, Type 2, Directly Observed Therapy, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rehabilitation programme in Adapted Physical Activity (APA)Procedure or surgery

  • Therapeutic education primarily focused on dietaryBehavioural

Study groups in NCT00234273
Study groupRoleWhat they receive
Therapeutic education combining dietary and rehabilitationExperimentalTherapeutic education combining dietary and rehabilitation (APA)
Receives: Procedure: Rehabilitation programme in Adapted Physical Activity (APA); Behavioral: Therapeutic education primarily focused on dietary
Therapeutic education primarily focused on dietaryActive comparatorTherapeutic education primarily focused on dietary
Receives: Behavioral: Therapeutic education primarily focused on dietary

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Increase physical activity compliance long-term

    Modifiable Activity Questionnaire (MAQ

    Measured: 6 months after the beginning of the program

  2. Lessen insulin resistance

    HOMA (Homeo-stasis model assessment), HbA1c, PCGL

    Measured: 6 months after the beginning of the program

Secondary outcomes (3)

  1. Improve the quality of life

    Short Form-36 Health Survey Questionnary (SF-36)

    Measured: 6 months after the beginning of the program

  2. Improve the arterial tension

    arterial tension

    Measured: 6 months after the beginning of the program

  3. Lessen the weight

    weight

    Measured: 6 months after the beginning of the program

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Oct 2005 (estimated)
  2. Study startNov 2004
  3. Primary completionJun 2008
  4. Study completionJun 2008

Why it stopped: recrutment

Resources

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 2
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00234273
Sponsor's protocol ID
DCIC 03 09
Status last verified
Jun 2013
First submitted
5 Oct 2005
Last updated
19 Jun 2013
Results posted
No
Data monitoring committee
No

Publications

  • Bouvard S, Faure P, Roucard C, Favier A, Halimi S. Characterization of free radical defense system in high glucose cultured HeLa-tat cells: consequences for glucose-induced cytotoxicity. Free Radic Res. 2002 Sep;36(9):1017-22. doi: 10.1080/107156021000006671.

    PubMed 12448827

  • Halimi S, Wion-Barbot N, Lambert S, Benhamou P. [Self-monitoring of blood glucose in type 2 diabetic patients. What could we propose according to their treatment?]. Diabetes Metab. 2003 Apr;29(2 Pt 2):S26-30. French.

    PubMed 12746623

  • Halimi S. [Therapeutic strategies for type 2 diabetes]. Rev Prat. 2003 May 15;53(10):1079-85. French.

    PubMed 12846028

  • Halimi S. [Is a new therapeutic class justified in the treatment of type 2 diabetes?]. Ann Endocrinol (Paris). 2002 Apr;63(2 Pt 2):1S7-11. French.

    PubMed 12037511

  • Halimi S, Charpentier G, Grimaldi A, Grenier JL, Baut F, Germain B, Magnette J. Effect on compliance, acceptability of blood glucose self-monitoring and HbA(1c) of a self-monitoring system developed according to patient's wishes. The ACCORD study. Diabetes Metab. 2001 Dec;27(6):681-7.

    PubMed 11852377

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Rehabilitation programme in Adapted Physical Activity (APA) and Therapeutic education primarily focused on dietary in people with NIDDM, run by University Hospital, Grenoble at 4 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: stopped early, as of the sponsor's last update on 19 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: recrutment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Increase physical activity compliance long-term (time frame: 6 months after the beginning of the program). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00234273, which also lists 5 linked publications.

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 19 Jun 2013.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in