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

This study is currently recruiting participants.
Verified by University Hospital, Grenoble, April 2007

Sponsored by: University Hospital, Grenoble
Information provided by: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT00234273
  Purpose

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.


Condition Intervention Phase
NIDDM
 Procedure: Rehabilitation programme in Adapted Physical Activity (APA)
 Phase II

MedlinePlus related topics:   Rehabilitation   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Educational/Counseling/Training, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
Official Title:   Effects Rehabilitation Programme in Adapted Physical Activity (APA) Among Type 2 Diabetics Persons

Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • Increase physical activity compliance long-term
  • Lessen insulin resistance

Secondary Outcome Measures:
  • Improve the quality of life
  • Improve the arterial tension
  • Lessen the weight
  • Improve body composition
  • Lessen abdominal perimeter
  • Lessen treatment dosage
  • Lessen the number of hospitalisations thick diabetes complications acute

Estimated Enrollment:   30
Study Start Date:   November 2004
Estimated Study Completion Date:   June 2008

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
Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00234273

Contacts
Contact: Cracowski Jean-Luc     0476769260     JLCracowski@chu-grenoble.fr    

Locations
France
HALIMI Serge     Recruiting
      Grenoble, France, 38000
      Contact: HALIMI Serge , MD     +33476765836     shalimi@chu-grenoble .fr    
      Contact: HALIMI Serge     0476765836     SHalmi@chu-grenoble.fr    
Endocrinology, Diabetology and Nutrition Department - University Hospital of Grenoble     Recruiting
      Grenoble, France, 38000
      Contact: HALIMI Serge            
      Principal Investigator: HALIMI Serge, MD            
France, Rhône-Alpes
Department of Endocrinology, Diabetology and Nutrition     Recruiting
      Grenoble, Rhône-Alpes, France, 38000
      Contact: HALIMI Serge     0476765836     SHalimi@chu-grenoble.fr    
      Principal Investigator: HALIMI serge, PU-PH            
      Principal Investigator: HALIMI Serge, PU-PH            
France, RHONE-ALPES
Endocrinology, Diabetology and Nutrition - University Hospital of Grenoble     Recruiting
      GRENOBLE, RHONE-ALPES, France, 38000
      Contact: HALIMI Serge, PU-PH     0476765836     SHalimi@chu-grenoble.fr    
      Contact: HALIMI Serge, PU-PH     0476765836     SHalimi@chu-grenoble.fr    

Sponsors and Collaborators
University Hospital, Grenoble

Investigators
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    
Principal Investigator:     HALIMI Serge     Institut National de la Santé Et de la Recherche Médicale, France    
  More Information


PubMed  This link exits the ClinicalTrials.gov site
 

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

Study ID Numbers:   DCIC 03 09
First Received:   October 5, 2005
Last Updated:   April 19, 2007
ClinicalTrials.gov Identifier:   NCT00234273
Health Authority:   France: Afssaps - French Health Products Safety Agency

Keywords provided by University Hospital, Grenoble:
Adapted Physical Activity  
Quality of life  
cardiovascular risk  
teaching
Directly Observed Therapy
Physical activity

Study placed in the following topic categories:
Quality of Life

ClinicalTrials.gov processed this record on October 17, 2008

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