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APAD2: Effects of Rehabilitation Programme in Adapted Physical Activity (APA) Among Type 2 Diabetics
Effects Rehabilitation Programme in Adapted Physical Activity (APA) Among Type 2 Diabetics Persons
1 other identifier
interventional
10
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Nov 2004
Typical duration for phase_2
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2004
CompletedFirst Submitted
Initial submission to the registry
October 5, 2005
CompletedFirst Posted
Study publicly available on registry
October 6, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedJune 19, 2013
June 1, 2013
3.6 years
October 5, 2005
June 18, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (3)
Improve the quality of life
6 months after the beginning of the program
Improve the arterial tension
6 months after the beginning of the program
Lessen the weight
6 months after the beginning of the program
Study Arms (2)
Therapeutic education combining dietary and rehabilitation
EXPERIMENTALTherapeutic education combining dietary and rehabilitation (APA)
Therapeutic education primarily focused on dietary
ACTIVE COMPARATORTherapeutic education primarily focused on dietary
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Department of Endocrinology, Diabetology and Nutrition
Grenoble, Auvergne-Rhône-Alpes, 38000, France
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
Related Publications (5)
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.
PMID: 12448827RESULTHalimi 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.
PMID: 12746623RESULTHalimi S. [Therapeutic strategies for type 2 diabetes]. Rev Prat. 2003 May 15;53(10):1079-85. French.
PMID: 12846028RESULTHalimi 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.
PMID: 12037511RESULTHalimi 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.
PMID: 11852377RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
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
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 5, 2005
First Posted
October 6, 2005
Study Start
November 1, 2004
Primary Completion
June 1, 2008
Study Completion
June 1, 2008
Last Updated
June 19, 2013
Record last verified: 2013-06