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

This study has been terminated.
(recrutment)
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT00234273
First received: October 5, 2005
Last updated: June 18, 2013
Last verified: June 2013
  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)
Behavioral: Therapeutic education primarily focused on dietary
Phase 2

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

Resource links provided by NLM:


Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • Increase physical activity compliance long-term [ Time Frame: 6 months after the beginning of the program ] [ Designated as safety issue: No ]
    Modifiable Activity Questionnaire (MAQ

  • Lessen insulin resistance [ Time Frame: 6 months after the beginning of the program ] [ Designated as safety issue: No ]
    HOMA (Homeo-stasis model assessment), HbA1c, PCGL


Secondary Outcome Measures:
  • Improve the quality of life [ Time Frame: 6 months after the beginning of the program ] [ Designated as safety issue: No ]
    Short Form-36 Health Survey Questionnary (SF-36)

  • Improve the arterial tension [ Time Frame: 6 months after the beginning of the program ] [ Designated as safety issue: No ]
    arterial tension

  • Lessen the weight [ Time Frame: 6 months after the beginning of the program ] [ Designated as safety issue: No ]
    weight


Enrollment: 10
Study Start Date: November 2004
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Locations
France
Endocrinology, Diabetology and Nutrition - University Hospital of Grenoble
Grenoble, Rhone-alpes, France, 38000
Department of Endocrinology, Diabetology and Nutrition
Grenoble, Rhône-Alpes, France, 38000
HALIMI Serge
Grenoble, France, 38000
Endocrinology, Diabetology and Nutrition Department - University Hospital of Grenoble
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
  More Information

Additional Information:
PubMed  This link exits the ClinicalTrials.gov site

Publications:
Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT00234273     History of Changes
Other Study ID Numbers: DCIC 03 09
Study First Received: October 5, 2005
Last Updated: June 18, 2013
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 April 14, 2014