Type 2 Diabetes Secondary Prevention

Type 2 Diabetes Clinical Trial

— RP2  

Official title:

Type 2 Diabetes Secondary Prevention Trial at the Reunion Island

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01207349
• Other study ID #: RBM01-23
• Status: Completed
• Phase: N/A
• First received: September 14, 2010
• Last updated: January 27, 2012
• Start date: August 2002
• Est. completion date: December 2004

Study information

• Verified date: January 2012
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Direction Générale de la Santé
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 398
• Est. completion date: December 2004
• Est. primary completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• type 2 diabetes patient aged >=18 years

Exclusion Criteria:

• incapacity to a moderate physical activity

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Behavioral:
• Secondary prevention intervention trial
Close follow-up by nurses, exercise physiologist and dieteticians
• standard follow up

Locations

Country	Name	City	State
France	GHSR	Saint Pierre	La Réunion

Sponsors (2)

Lead Sponsor	Collaborator
Institut National de la Santé Et de la Recherche Médicale, France	Groupe Hospitalier Sud Réunion

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	%HbA1c	measure of % HbA1c at inclusion and at one year and comparison between intervention and control groups	at inclusion and at one year	Yes
Secondary	anthropometry	BMI, waist, %fat mass and comparison between intervention and control groups	at inclusion and at one year	Yes