APAD2: Effects of Rehabilitation Programme in Adapted Physical Activity (APA) Among Type 2 Diabetics
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About
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.
Full 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
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Type 2 diabetics
- Age > 40
- First education in the Education Diabetics Department of the University Hospital Grenoble
- Sedentary patients
- Hemoglobin A1c (HbA1c) > 7%
- Body mass index (BMI) > 25
- To be affiliated with disease assurance
- To give written and informed consent
Exclusion criteria
- Foot sore < six months
- Renal disease - proteinuria stage
- Contraindication for exercise
- VO2 max > 120% Wassermann standard
- Coronary pathology non-stabilization
- Arteriopathy stage 2 non-compensation
- Osteo-articular crippling problem
- Geographically distant
Trial design
10 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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