Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00234273
Status:
TERMINATED
Last Update Posted:
2013-06-19
First Post:
2005-10-05
Brief Title:
APAD2 Effects of Rehabilitation Programme in Adapted Physical Activity APA Among Type 2 Diabetics
Sponsor:
University Hospital Grenoble
Organization:
University Hospital Grenoble
Study Overview
Official Title:
Effects Rehabilitation Programme in Adapted Physical Activity APA Among Type 2 Diabetics Persons
Status:
TERMINATED
Status Verified Date:
2013-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
recrutment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 exercises 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
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 exercises 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None