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

Phase 2

Terminated

• Conditions: NIDDM
• Interventions: Procedure: Rehabilitation programme in Adapted Physical Activity (APA); Behavioral: Therapeutic education primarily focused on dietary

• Registration Number: NCT00234273
• Lead Sponsor: University Hospital, Grenoble

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

Study Timeline

• Study Start: 2004-11
• Study First Submitted: 2005-10-05
• Study First Submitted QC: 2005-10-05
• Study First Posted: 2005-10-06
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-18
• Last Update Posted: 2013-06-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Therapeutic education combining dietary and rehabilitation	Rehabilitation programme in Adapted Physical Activity (APA)	Therapeutic education combining dietary and rehabilitation (APA)
Therapeutic education combining dietary and rehabilitation	Therapeutic education primarily focused on dietary	Therapeutic education combining dietary and rehabilitation (APA)
Therapeutic education primarily focused on dietary	Therapeutic education primarily focused on dietary	Therapeutic education primarily focused on dietary

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Improve the quality of life	6 months after the beginning of the program	Short Form-36 Health Survey Questionnary (SF-36)

Trial Locations

Locations (4)

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, France

Department of Endocrinology, Diabetology and Nutrition; 🇫🇷 Grenoble, Rhône-Alpes, France