APAD2: Effects of Rehabilitation Programme in Adapted Physical Activity (APA) Among Type 2 Diabetics

NIDDM Clinical Trial

Official title: Effects Rehabilitation Programme in Adapted Physical Activity (APA) Among Type 2 Diabetics Persons

Status Terminated

Clinical Trial Summary

The principal objective is to assess and analyze the effects of a six month programme in Adapted Physical Activity (APA) on physical activity, compliance, and insulin resistance among type 2 diabetics.

Clinical Trial Description

Clinical trial with direct individual profit. Study phase 2. Study center: University Hospital Grenoble Principal investigator: Pr. Serge HALIMI Sponsor: University Hospital Grenoble

The principal objective is to assess and analyze the effects of a six month programme in Adapted Physical Activity (APA) on physical activity, compliance, and insulin resistance among type 2 diabetics.

Secondary objectives are to assess and analyze the effects of a six month programme in APA of:

• arterial tension

• weight, body composition and abdominal perimeter

• quality of life

• treatment dosage

• number of hospitalisation thick a diabetes complication acute for one year and for each patient Compare two exercise's intensity: first lactate threshold (SL1) and crossover (PCGL).

Inclusion criteria:

• type 2 diabetics

• age > 40 years

• first education in Education Diabetics Department of University Hospital Grenoble

• sedentary patients

• HbA1c > 7%-

• BMI > 25

• to be affiliate disease assurance

• to give consent written and inform

Judgment criteria for physical activity compliance:

• leisure time physical activity: Modifiable Activity Questionnaire

• training note-book

Judgment criteria for resistance insulin:

• Crossover (PCGL)

• HOMA and FIRI index

• HbA1c

Programme test: Rehabilitation programme in Adapted Physical Activity (APA)

Programme test period: 6 months

Study total period: 28 months

Study period for each patient: 18 months

Safety criteria: clinical compendium undesirable events ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• NIDDM

• NCT number: NCT00234273
• Study type: Interventional
• Source: University Hospital, Grenoble
• Status: Terminated
• Phase: Phase 2
• Start date: November 2004
• Completion date: June 2008