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Type 2 Diabetes Secondary Prevention (RP2)

This study has been completed.
Sponsor:
Collaborator:
Groupe Hospitalier Sud Réunion
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier:
NCT01207349
First received: September 14, 2010
Last updated: January 27, 2012
Last verified: January 2012
History of Changes

September 14, 2010
January 27, 2012
August 2002
December 2004   (final data collection date for primary outcome measure)
%HbA1c [ Time Frame: at inclusion and at one year ] [ Designated as safety issue: Yes ]
measure of % HbA1c at inclusion and at one year and comparison between intervention and control groups
Same as current
Complete list of historical versions of study NCT01207349 on ClinicalTrials.gov Archive Site
anthropometry [ Time Frame: at inclusion and at one year ] [ Designated as safety issue: Yes ]
BMI, waist, %fat mass and comparison between intervention and control groups
Same as current
Not Provided
Not Provided
 
Type 2 Diabetes Secondary Prevention
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.
Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

type 2 diabetic patients
Type 2 Diabetes
  • Behavioral: Secondary prevention intervention trial
    Close follow-up by nurses, exercise physiologist and dieteticians
    Other Name: Rédia-prev2
  • Behavioral: standard follow up
  • close follow-up by nurse
    close follow-up by nurse : patients were visited each tree months
    Intervention: Behavioral: Secondary prevention intervention trial
  • standard follow up
    stantdard follow up at one year
    Intervention: Behavioral: standard follow up
Debussche X, Rollot O, Le Pommelet C, Fianu A, Le Moullec N, Régnier 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. Epub 2011 Oct 24.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
398
December 2004
December 2004   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • type 2 diabetes patient aged >=18 years

Exclusion Criteria:

  • incapacity to a moderate physical activity
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01207349
RBM01-23
Yes
Institut National de la Santé Et de la Recherche Médicale, France
Institut National de la Santé Et de la Recherche Médicale, France
Groupe Hospitalier Sud Réunion
Study Director: Jean-Claude Schwager, MD GHSR
Institut National de la Santé Et de la Recherche Médicale, France
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP