Type 2 Diabetes Secondary Prevention (RP2)

January 27, 2012 updated by: Institut National de la Santé Et de la Recherche Médicale, France

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

398

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • La Réunion
      • Saint Pierre, La Réunion, France, 97448
        • GHSR

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

type 2 diabetic patients

Description

Inclusion Criteria:

  • type 2 diabetes patient aged >=18 years

Exclusion Criteria:

  • incapacity to a moderate physical activity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

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 Names:
  • Rédia-prev2
standard follow up
stantdard follow up at one year
Behavioral: standard follow up

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
%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
at inclusion and at one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
anthropometry
Time Frame: at inclusion and at one year
BMI, waist, %fat mass and comparison between intervention and control groups
at inclusion and at one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Collaborators

Groupe Hospitalier Sud Réunion

Investigators

  • Study Director: Jean-Claude Schwager, MD, GHSR

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2002

Primary Completion (Actual)

December 1, 2004

Study Completion (Actual)

December 1, 2004

Study Registration Dates

First Submitted

September 14, 2010

First Submitted That Met QC Criteria

September 21, 2010

First Posted (Estimate)

September 22, 2010

Study Record Updates

Last Update Posted (Estimate)

January 31, 2012

Last Update Submitted That Met QC Criteria

January 27, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RBM01-23

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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