Type 2 DiabetesRP2NCT01207349
Type 2 Diabetes Secondary Prevention
An observational study of Type 2 Diabetes, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial summary
Three hundred and ninety height diabetic patients were educated during a week of hospitalisation (nutritional and physical-activity advices). After that, they were randomized in two groups : frequent follow-up (each three month) by educational nurses and dieteticians, versus no follow-up (control group). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Secondary prevention intervention trial and standard follow up
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 398 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2002to Dec 2004
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: type 2 diabetic patients
Who may be able to join
- type 2 diabetes patient aged >=18 years
Who cannot join
- incapacity to a moderate physical activity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Type 2 Diabetes Secondary Prevention Trial at the Reunion Island
Three hundred and ninety height diabetic patients were educated during a week of hospitalisation (nutritional and physical-activity advices). After that, they were randomized in two groups : frequent follow-up (each three month) by educational nurses and dieteticians, versus no follow-up (control group). All patients were evaluated one year after their inclusion,by HbA1c (primary outcome), anthropometry, other cardiovascular risk factors, nutritionnal and physical-activity behaviours.
- Conditions
- Type 2 Diabetes
- Being tested
- Secondary prevention intervention trial, standard follow up
- Keywords
- Type 2 diabetes, Secondary prevention, Physical activity, Nutritional education, HbA1c, Reunion island, diabetic patients, both female and male, age >=18 years, able to practise a physical activity, in Saint Pierre (GHSR) and Saint Denis (CHD)
- Medical subject headings
- Diabetes Mellitus, Type 2, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Secondary prevention intervention trialBehavioural
Also called Rédia-prev2
Close follow-up by nurses, exercise physiologist and dieteticians
standard follow upBehavioural
| Study group | Role | What they receive |
|---|---|---|
| close follow-up by nurse | close follow-up by nurse : patients were visited each tree months Receives: Behavioral: Secondary prevention intervention trial | |
| standard follow up | stantdard follow up at one year Receives: Behavioral: standard follow up |
What is being measured
The primary outcome is the main question the study is designed to answer.
%HbA1c
measure of % HbA1c at inclusion and at one year and comparison between intervention and control groups
Measured: at inclusion and at one year
Secondary outcomes (1)
anthropometry
BMI, waist, %fat mass and comparison between intervention and control groups
Measured: at inclusion and at one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2010 (estimated)
- Study startAug 2002
- Primary completionDec 2004
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 398 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Collaborators
- Groupe Hospitalier Sud Reunion
- Responsible party
- Sponsor
- Investigators
- Jean-Claude Schwager, MD, Study director, GHSR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01207349
- Sponsor's protocol ID
- RBM01-23
- Acronym
- RP2
- Status last verified
- Jan 2012
- First submitted
- 14 Sep 2010
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Debussche X, Rollot O, Le Pommelet C, Fianu A, Le Moullec N, Regnier C, Boyer MC, Cogne M, Bakiri F, Schwager JC, Favier F. Quarterly individual outpatients lifestyle counseling after initial inpatients education on type 2 diabetes: the REDIA Prev-2 randomized controlled trial in Reunion Island. Diabetes Metab. 2012 Feb;38(1):46-53. doi: 10.1016/j.diabet.2011.07.002. Epub 2011 Oct 24.
PubMed 22030240
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Type 2 Diabetes Secondary Prevention Trial at the Reunion Island
- ClinicalTrials.gov ID
- NCT01207349
- Acronym / sponsor ID
- RP2 / RBM01-23
- Conditions
- Type 2 Diabetes
- Keywords
- Type 2 diabetes, Secondary prevention, Physical activity, Nutritional education, HbA1c, Reunion island, diabetic patients, both female and male, age >=18 years, able to practise a physical activity, in Saint Pierre (GHSR) and Saint Denis (CHD)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 398 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Collaborators
- Groupe Hospitalier Sud Reunion
- Study start
- Aug 2002
- Primary completion
- Dec 2004 (actual)
- Study completion
- Dec 2004 (actual)
- First posted
- 22 Sep 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.
Three hundred and ninety height diabetic patients were educated during a week of hospitalisation (nutritional and physical-activity advices). After that, they were randomized in two groups : frequent follow-up (each three month) by educational nurses and dieteticians, versus no follow-up (control group). All patients were evaluated one year after their inclusion,by HbA1c (primary outcome), anthropometry, other cardiovascular risk factors, nutritionnal and physical-activity behaviours.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| close follow-up by nurse | – | Behavioral: Secondary prevention intervention trialclose follow-up by nurse : patients were visited each tree months |
| standard follow up | – | Behavioral: standard follow upstantdard follow up at one year |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- type 2 diabetic patients
Key inclusion criteria (1 listed)
- type 2 diabetes patient aged >=18 years
Key exclusion criteria (1 listed)
- incapacity to a moderate physical activity
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 |
|---|---|---|
| Secondary prevention intervention trialAlso: Rédia-prev2Close follow-up by nurses, exercise physiologist and dieteticians | Behavioural | close follow-up by nurse |
| standard follow up | Behavioural | standard follow up |
Primary outcome
%HbA1c
Time frame: at inclusion and at one year
measure of % HbA1c at inclusion and at one year and comparison between intervention and control groups
1 secondary outcome
anthropometry
Time frame: at inclusion and at one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Results publication: PubMed 22030240Debussche X, Rollot O, Le Pommelet C, Fianu A, Le Moullec N, Regnier C, Boyer MC, Cogne M, Bakiri F, Schwager JC, Favier F. Quarterly individual outpatients lifestyle counseling after initial inpatients education on type 2 diabetes: the REDIA Prev-2 randomized controlled trial in Reunion Island. Diabetes Metab. 2012 Feb;38(1):46-53. doi: 10.1016/j.diabet.2011.07.002. Epub 2011 Oct 24.
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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.
Jean-Claude Schwager, MD study director
GHSR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
%HbA1c (time frame: at inclusion and at one year). 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 NCT01207349, which also lists 1 linked publication.
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 4 Dec 2025.