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

Sponsor

University Hospital, Grenoble (Other)

Overall Status

Terminated

CT.gov ID

NCT00234273

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

2.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
NIDDM	Procedure: Rehabilitation programme in Adapted Physical Activity (APA) Behavioral: Therapeutic education primarily focused on dietary	Phase 2

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

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

Study Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Official Title:

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

Study Start Date :

Nov 1, 2004

Actual Primary Completion Date :

Jun 1, 2008

Actual Study Completion Date :

Jun 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Therapeutic education combining dietary and rehabilitation Therapeutic education combining dietary and rehabilitation (APA)	Procedure: Rehabilitation programme in Adapted Physical Activity (APA) Behavioral: Therapeutic education primarily focused on dietary
Active Comparator: Therapeutic education primarily focused on dietary Therapeutic education primarily focused on dietary	Behavioral: Therapeutic education primarily focused on dietary

Arm

Intervention/Treatment

Experimental: Therapeutic education combining dietary and rehabilitation

Therapeutic education combining dietary and rehabilitation (APA)

Procedure: Rehabilitation programme in Adapted Physical Activity (APA)

Behavioral: Therapeutic education primarily focused on dietary

Active Comparator: Therapeutic education primarily focused on dietary

Therapeutic education primarily focused on dietary

Behavioral: Therapeutic education primarily focused on dietary

Outcome Measures

Primary Outcome Measures

Increase physical activity compliance long-term [6 months after the beginning of the program]
Modifiable Activity Questionnaire (MAQ
Lessen insulin resistance [6 months after the beginning of the program]
HOMA (Homeo-stasis model assessment), HbA1c, PCGL

Secondary Outcome Measures

Improve the quality of life [6 months after the beginning of the program]
Short Form-36 Health Survey Questionnary (SF-36)
Improve the arterial tension [6 months after the beginning of the program]
arterial tension
Lessen the weight [6 months after the beginning of the program]
weight

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Endocrinology, Diabetology and Nutrition - University Hospital of Grenoble	Grenoble	Rhone-alpes	France	38000
2	Department of Endocrinology, Diabetology and Nutrition	Grenoble	Rhône-Alpes	France	38000
3	Endocrinology, Diabetology and Nutrition Department - University Hospital of Grenoble	Grenoble		France	38000
4	HALIMI Serge	Grenoble		France	38000

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