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

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 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Educational/Counseling/Training
Official Title:	Effects Rehabilitation Programme in Adapted Physical Activity (APA) Among Type 2 Diabetics Persons

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Medicines Rehabilitation

U.S. FDA Resources

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
Endocrinology, Diabetology and Nutrition - University Hospital of Grenoble	Recruiting
Grenoble, Rhone-alpes, France, 38000
Contact: HALIMI Serge, PU-PH 0476765836 SHalimi@chu-grenoble.fr
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
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

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

More Information

Additional Information:

PubMed

This link exits the ClinicalTrials.gov site

Publications:

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.

ClinicalTrials.gov Identifier:	NCT00234273 History of Changes
Other Study ID Numbers:	DCIC 03 09
Study First Received:	October 5, 2005
Last Updated:	April 19, 2007
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Grenoble:

Adapted Physical Activity
Quality of life
cardiovascular risk

teaching
Directly Observed Therapy
Physical activity

Additional relevant MeSH terms:

Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on June 13, 2013