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Type 2 Diabetes Secondary Prevention (RP2)

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ClinicalTrials.gov Identifier: NCT01207349
Recruitment Status : Completed
First Posted : September 22, 2010
Last Update Posted : January 31, 2012
Sponsor:
Collaborator:
Groupe Hospitalier Sud Réunion
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France

Brief 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.

Condition or disease Intervention/treatment
Type 2 Diabetes Behavioral: Secondary prevention intervention trial Behavioral: standard follow up

Study Type : Observational
Actual Enrollment : 398 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Type 2 Diabetes Secondary Prevention Trial at the Reunion Island
Study Start Date : August 2002
Actual Primary Completion Date : December 2004
Actual Study Completion Date : December 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
close follow-up by nurse
close follow-up by nurse : patients were visited each tree months
Behavioral: Secondary prevention intervention trial
Close follow-up by nurses, exercise physiologist and dieteticians
Other Name: Rédia-prev2
standard follow up
stantdard follow up at one year
Behavioral: standard follow up



Primary Outcome Measures :
  1. %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


Secondary Outcome Measures :
  1. anthropometry [ Time Frame: at inclusion and at one year ]
    BMI, waist, %fat mass and comparison between intervention and control groups



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
type 2 diabetic patients
Criteria

Inclusion Criteria:

  • type 2 diabetes patient aged >=18 years

Exclusion Criteria:

  • incapacity to a moderate physical activity

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01207349


Locations
France
GHSR
Saint Pierre, La Réunion, France, 97448
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
Groupe Hospitalier Sud Réunion
Investigators
Study Director: Jean-Claude Schwager, MD GHSR

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT01207349     History of Changes
Other Study ID Numbers: RBM01-23
First Posted: September 22, 2010    Key Record Dates
Last Update Posted: January 31, 2012
Last Verified: January 2012

Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:
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)

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases