Clinical trial NCT00234273: APAD2: Effects of Rehabilitation Programme in Adapted Physical Activity (APA) Among Type 2 Diabetics
Official title: Effects Rehabilitation Programme in Adapted Physical Activity (APA) Among Type 2 Diabetics Persons
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: NIDDM
Keywords: Adapted Physical Activity
Quality of life
cardiovascular risk
teaching
Directly Observed Therapy
Physical activity
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2005-10-06
Enrollment: 10
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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

Eligibility criteria: 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

Primary outcomes:
measure: Increase physical activity compliance long-term
timeFrame: 6 months after the beginning of the program
measure: Lessen insulin resistance
timeFrame: 6 months after the beginning of the program
Secondary outcomes:
measure: Improve the quality of life
timeFrame: 6 months after the beginning of the program
measure: Improve the arterial tension
timeFrame: 6 months after the beginning of the program
measure: Lessen the weight
timeFrame: 6 months after the beginning of the program
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Endocrinology, Diabetology and Nutrition - University Hospital of Grenoble
state: Rhone-alpes
city: Grenoble
country: France
facility: Department of Endocrinology, Diabetology and Nutrition
state: Rhône-Alpes
city: Grenoble
country: France
facility: Endocrinology, Diabetology and Nutrition Department - University Hospital of Grenoble
city: Grenoble
country: France
facility: HALIMI Serge
Study officials:
affiliation: Institut National de la Santé Et de la Recherche Médicale, France
name: HALIMI Serge
role: PRINCIPAL_INVESTIGATOR
affiliation: Institut National de la Santé Et de la Recherche Médicale, France
name: Halimi S. Therapeutic strategies for type 2 diabetes. Rev Prat HALIMI
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: Halimi S. [Therapeutic strategies for type 2 diabetes]. Rev Prat. 2003 May 15;53(10):1079-85. French.
citation: 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.
citation: 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.