APAD2: Effects of Rehabilitation Programme in Adapted Physical Activity (APA) Among Type 2 Diabetics

NIDDM Clinical Trial

Official title:

Effects Rehabilitation Programme in Adapted Physical Activity (APA) Among Type 2 Diabetics Persons

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00234273
• Other study ID #: DCIC 03 09
• Status: Terminated
• Phase: Phase 2
• First received: October 5, 2005
• Last updated: June 18, 2013
• Start date: November 2004
• Est. completion date: June 2008

Study information

• Verified date: June 2013
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• NIDDM

Intervention

Procedure:
• Rehabilitation programme in Adapted Physical Activity (APA)

Behavioral:
• Therapeutic education primarily focused on dietary

Locations

Country	Name	City	State
France	Department of Endocrinology, Diabetology and Nutrition	Grenoble	Rhône-Alpes
France	Endocrinology, Diabetology and Nutrition - University Hospital of Grenoble	Grenoble	Rhone-alpes
France	Endocrinology, Diabetology and Nutrition Department - University Hospital of Grenoble	Grenoble
France	HALIMI Serge	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & 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. — View 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. Diabete — View 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. Review. French. — View 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. Review. French. — View Citation

Halimi S. [Therapeutic strategies for type 2 diabetes]. Rev Prat. 2003 May 15;53(10):1079-85. Review. French. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase physical activity compliance long-term	Modifiable Activity Questionnaire (MAQ	6 months after the beginning of the program	No
Primary	Lessen insulin resistance	HOMA (Homeo-stasis model assessment), HbA1c, PCGL	6 months after the beginning of the program	No
Secondary	Improve the quality of life	Short Form-36 Health Survey Questionnary (SF-36)	6 months after the beginning of the program	No
Secondary	Improve the arterial tension	arterial tension	6 months after the beginning of the program	No
Secondary	Lessen the weight	weight	6 months after the beginning of the program	No

External Links

•   PubMed