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

Phase 2

Terminated

• Conditions: NIDDM

• 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

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

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

Endocrinology, Diabetology and Nutrition Department - University Hospital of Grenoble; 🇫🇷 Grenoble, France

HALIMI Serge; 🇫🇷 Grenoble, France