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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 20, 2014