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CompletedNCT01207349RP2Updated Dec 4, 2025

Type 2 Diabetes Secondary Prevention

An observational study in Type 2 Diabetes, sponsored by Institut National de la Santé Et de la Recherche Médicale, France. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-04.

Sponsored by Institut National de la Santé Et de la Recherche Médicale, France · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
398
Ages
18 Years and older
Sex
All
01

Study 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). All patients were evaluated one year after their inclusion,by HbA1c (primary outcome), anthropometry, other cardiovascular risk factors, nutritionnal and physical-activity behaviours.

02

Conditions studied

  • 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)
03

In context

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's enrollment of 398 is above the median of 300 across 1,588 observational studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Institut National de la Santé Et de la Recherche Médicale, France is the lead sponsor of 375 studies on the registry; 82 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

type 2 diabetic patients

Inclusion criteria

  • type 2 diabetes patient aged >=18 years

Exclusion criteria

Exclusion Criteria:

  • incapacity to a moderate physical activity
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
398 participants (actual)

Groups and cohorts

  • close follow-up by nurse

    close follow-up by nurse : patients were visited each tree months

    Behavioral: Secondary prevention intervention trial

  • standard follow up

    stantdard follow up at one year

    Behavioral: standard follow up

Interventions

  • BehavioralSecondary prevention intervention trial

    Close follow-up by nurses, exercise physiologist and dieteticians

    Also known as: Rédia-prev2

  • Behavioralstandard follow up
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What researchers measure

Primary outcomes

  1. %HbA1c

    measure of % HbA1c at inclusion and at one year and comparison between intervention and control groups

    Time frame: at inclusion and at one year

Secondary outcomes

  1. anthropometry

    BMI, waist, %fat mass and comparison between intervention and control groups

    Time frame: at inclusion and at one year

07

Study locations

1 site
  • GHSR
    Saint-Pierre, La Réunion 97448, France
08

References and documents

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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01207349
Lead sponsor
Institut National de la Santé Et de la Recherche Médicale, France
Collaborators
Groupe Hospitalier Sud Reunion
Responsible party
Sponsor
First posted
Sep 22, 2010
Start date
Aug 2002
Primary completion
Dec 2004
Completion
Dec 2004
Last update
Dec 4, 2025

Study contacts

Jean-Claude Schwager, MD
study director · GHSR

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.

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