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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2008-06-30

Brief Summary

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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.

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Detailed Description

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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

Conditions

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NIDDM

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Therapeutic education combining dietary and rehabilitation

Therapeutic education combining dietary and rehabilitation (APA)

Group Type EXPERIMENTAL

Rehabilitation programme in Adapted Physical Activity (APA)

Intervention Type PROCEDURE

Therapeutic education primarily focused on dietary

Intervention Type BEHAVIORAL

Therapeutic education primarily focused on dietary

Group Type ACTIVE_COMPARATOR

Therapeutic education primarily focused on dietary

Intervention Type BEHAVIORAL

Interventions

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Rehabilitation programme in Adapted Physical Activity (APA)

Intervention Type PROCEDURE

Therapeutic education primarily focused on dietary

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes