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
  Purpose

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 Intervention
Type 2 Diabetes
Behavioral: Secondary prevention intervention trial
Behavioral: standard follow up

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Type 2 Diabetes Secondary Prevention Trial at the Reunion Island

Resource links provided by NLM:


Further study details as provided by Institut National de la Santé Et de la Recherche Médicale, France:

Primary Outcome Measures:
  • %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


Secondary Outcome Measures:
  • 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


Enrollment: 398
Study Start Date: August 2002
Study Completion Date: December 2004
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by Institut National de la Santé Et de la Recherche Médicale, France

Additional 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
Study First Received: September 14, 2010
Last Updated: January 27, 2012
Health Authority: France: Direction Générale de la Santé

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

ClinicalTrials.gov processed this record on July 31, 2014