Type 2 Diabetes Secondary Prevention

NCT ID: NCT01207349

Last Updated: 2012-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

398 participants

Study Classification

OBSERVATIONAL

Study Start Date

2002-08-31

Study Completion Date

2004-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Type 2 Diabetes

Keywords

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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)

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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close follow-up by nurse

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

Secondary prevention intervention trial

Intervention Type BEHAVIORAL

Close follow-up by nurses, exercise physiologist and dieteticians

standard follow up

stantdard follow up at one year

standard follow up

Intervention Type BEHAVIORAL

Interventions

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Secondary prevention intervention trial

Close follow-up by nurses, exercise physiologist and dieteticians

Intervention Type BEHAVIORAL

standard follow up

Intervention Type BEHAVIORAL

Other Intervention Names

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Rédia-prev2

Eligibility Criteria

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Inclusion Criteria

* type 2 diabetes patient aged \>=18 years

Exclusion Criteria

* incapacity to a moderate physical activity
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Groupe Hospitalier Sud Réunion

UNKNOWN

Sponsor Role collaborator

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

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Claude Schwager, MD

Role: STUDY_DIRECTOR

GHSR

Locations

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GHSR

Saint-Pierre, La Réunion, France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 22030240 (View on PubMed)

Other Identifiers

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RBM01-23

Identifier Type: -

Identifier Source: org_study_id