NIDDM
Conditions
Keywords
Adapted Physical Activity, Quality of life, cardiovascular risk, teaching, Directly Observed Therapy, Physical activity
Brief 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.
Detailed 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
Interventions
PROCEDURERehabilitation programme in Adapted Physical Activity (APA)
BEHAVIORALTherapeutic education primarily focused on dietary
Sponsors
University Hospital, Grenoble
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Increase physical activity compliance long-term | 6 months after the beginning of the program | Modifiable Activity Questionnaire (MAQ |
| Lessen insulin resistance | 6 months after the beginning of the program | HOMA (Homeo-stasis model assessment), HbA1c, PCGL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improve the quality of life | 6 months after the beginning of the program | Short Form-36 Health Survey Questionnary (SF-36) |
| Improve the arterial tension | 6 months after the beginning of the program | arterial tension |
| Lessen the weight | 6 months after the beginning of the program | weight |
Countries
France
Outcome results
None listed