Not provided
Not provided
Not provided
Not provided
Not provided
recrutment
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 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:
Inclusion criteria:
Judgment criteria for physical activity compliance:
Judgment criteria for resistance insulin:
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
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Therapeutic education combining dietary and rehabilitation | Experimental | Therapeutic education combining dietary and rehabilitation (APA) |
|
| Therapeutic education primarily focused on dietary | Active Comparator | Therapeutic education primarily focused on dietary |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rehabilitation programme in Adapted Physical Activity (APA) | Procedure |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| Increase physical activity compliance long-term | Modifiable Activity Questionnaire (MAQ | 6 months after the beginning of the program |
| Lessen insulin resistance | HOMA (Homeo-stasis model assessment), HbA1c, PCGL | 6 months after the beginning of the program |
| Measure | Description | Time Frame |
|---|---|---|
| Improve the quality of life | Short Form-36 Health Survey Questionnary (SF-36) | 6 months after the beginning of the program |
| Improve the arterial tension | arterial tension |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| HALIMI Serge | Institut National de la Santé Et de la Recherche Médicale, France | Principal Investigator |
| Halimi S. Therapeutic strategies for type 2 diabetes. Rev Prat HALIMI | Institut National de la Santé Et de la Recherche Médicale, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Endocrinology, Diabetology and Nutrition | Grenoble | Auvergne-Rhône-Alpes | 38000 | France | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12448827 | Result | Bouvard S, Faure P, Roucard C, Favier A, Halimi S. Characterization of free radical defense system in high glucose cultured HeLa-tat cells: consequences for glucose-induced cytotoxicity. Free Radic Res. 2002 Sep;36(9):1017-22. doi: 10.1080/107156021000006671. | |
| 12746623 | Result | Halimi S, Wion-Barbot N, Lambert S, Benhamou P. [Self-monitoring of blood glucose in type 2 diabetic patients. What could we propose according to their treatment?]. Diabetes Metab. 2003 Apr;29(2 Pt 2):S26-30. French. |
| Label | URL |
|---|---|
| PubMed | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Therapeutic education primarily focused on dietary |
| Behavioral |
|
| 6 months after the beginning of the program |
| Lessen the weight | weight | 6 months after the beginning of the program |
| Endocrinology, Diabetology and Nutrition - University Hospital of Grenoble |
| Grenoble |
| Auvergne-Rhône-Alpes |
| 38000 |
| France |
| Endocrinology, Diabetology and Nutrition Department - University Hospital of Grenoble | Grenoble | 38000 | France |
| HALIMI Serge | Grenoble | 38000 | France |
| 12846028 | Result | Halimi S. [Therapeutic strategies for type 2 diabetes]. Rev Prat. 2003 May 15;53(10):1079-85. French. |
| 12037511 | Result | Halimi S. [Is a new therapeutic class justified in the treatment of type 2 diabetes?]. Ann Endocrinol (Paris). 2002 Apr;63(2 Pt 2):1S7-11. French. |
| 11852377 | Result | Halimi S, Charpentier G, Grimaldi A, Grenier JL, Baut F, Germain B, Magnette J. Effect on compliance, acceptability of blood glucose self-monitoring and HbA(1c) of a self-monitoring system developed according to patient's wishes. The ACCORD study. Diabetes Metab. 2001 Dec;27(6):681-7. |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D023801 | Directly Observed Therapy |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D055118 | Medication Adherence |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
Not provided
Not provided