HIIE and Abdominal Fat Mass in DT2 Postmenopausal Women
Primary Purpose
Type 2 Diabetes, Overweight (BMI > 25), Postmenopausal Women
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Physical activity programs steady-state exercise (SSE) program
Physical activity programs high intensity intermittent exercise (HIIE)
Sponsored by
About this trial
This is an interventional diagnostic trial for Type 2 Diabetes focused on measuring intermittent sprinting, abdominal fat mass, type 2 diabetes, postmenopausal women
Eligibility Criteria
Inclusion Criteria:
- postmenopausal women (55- 82 years)
- T2D
- BMI ≥ 25 and < 40
- able to follow an exercise protocol
- eating behavior and physical activity stable since at least 3 month
Exclusion Criteria:
- - subject not able to perform exercise after medical examination
- subject not able to perform bicycle exercise (pains)
- chronic infection
- use of β-blocker
- medical treatment that could interfere with the different outcome measures
- Hormonal Replacement Therapy (HRT)
- regular consumption of alcohol
- refusal to sign the consent form
Sites / Locations
- Chu Clermont Ferrand
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
steady-state exercise (SSE)
high intensity intermittent exercise (HIIE)
Arm Description
The aim of our study was to compare the effects of 16-week steady-state exercise (SSE) program with high intensity intermittent exercise (HIIE) program on total abdominal and visceral fat mass in T2D postmenopausal women.
The aim of our study was to compare the effects of 16-week steady-state exercise (SSE) program with high intensity intermittent exercise (HIIE) program on total abdominal and visceral fat mass in T2D postmenopausal women.
Outcomes
Primary Outcome Measures
loss of abdominal fat mass (g)
Total abdominal fat mass will be measured in all patients from DXA using the methodology of Martin et Jensen (1991; L1-L2 to pubic rami) before (baseline, T0) and after 4 months of training (T4).
Secondary Outcome Measures
Change from baseline in visceral fat mass (g)
calculated from computer tomography, Sottier et al. 2013
Change from baseline in total fat mass (g) determined from DXA
determined from DXA
Change from baseline in total fat free mass (g) determined from DXA
determined from DXA
Change from baseline in glycemic profile (plasma HbA1c and plasma glucose measurements)
plasma HbA1c and plasma glucose measurements
Change from baseline in lipid profile (plasma TG, HDL, LDL and total cholesterol measurements)
plasma TG, HDL, LDL and total cholesterol measurements
Change from baseline in food behavior after training (visual analog scale from Flint et al. 2000)
visual analog scale from Flint et al. 2000
Full Information
NCT ID
NCT02352246
First Posted
January 19, 2015
Last Updated
January 30, 2015
Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Laboratory of metabolic adaptation to exercise under Physiological and Physiopathological conditions (AME2)
1. Study Identification
Unique Protocol Identification Number
NCT02352246
Brief Title
HIIE and Abdominal Fat Mass in DT2 Postmenopausal Women
Official Title
Effect of High-Intensity Intermittent Exercise on Abdominal Fat Mass in Type 2 Diabetes Postmenopausal Women.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Unknown status
Study Start Date
February 2015 (undefined)
Primary Completion Date
July 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Laboratory of metabolic adaptation to exercise under Physiological and Physiopathological conditions (AME2)
4. Oversight
5. Study Description
Brief Summary
Postmenopausal women, as men, are more prone to central or android obesity. Abdominal fat mass is associated with an increase of cardiovascular diseases (CVD). In type 2 diabetic (T2D) patients, the risk of CVD mortality is more than double compared with that in age-matched subjects.
Most exercise programs designed for weight loss have focused on steady-state exercise (SEE) of around 30 min at a moderate intensity several times a week. Disappointingly, these kinds of exercise programs have led to little or no fat loss (Shaw et al. 2006). Accumulating evidence suggests that high intensity intermittent exercise (HIIE) has the potential to be an effective exercise protocol for reducing fat of overweight individuals, especially at the abdominal level (Boutcher 2011, Kessler 2012). Despite these results, HIIE program has never been used in TD2 postmenopausal women to favor a specific decrease of abdominal fat mass.
The aim of our study was to compare the effects of 16-week steady-state exercise (SSE) program with high intensity intermittent exercise (HIIE) program on total abdominal and visceral fat mass in T2D postmenopausal women.
It is hypothesized that HIIE compared to SSE program would result in significantly greater reductions in total abdominal and visceral fat mass.
Detailed Description
Overweight and obesity levels have escalated worldwide, and these trends are occurring in both developed and developing countries. Fat mass and more precisely abdominal fat mass is linked to the development of cardio-vascular diseases (CVD). Postmenopausal women, as men, are more prone to central or android obesity. In type 2 diabetic (T2D) patients, the risk of CVD mortality is more than double compared with that in age-matched subjects.
Most exercise programs designed for weight loss have focused on steady-state exercise (SEE) during at least 30 min, 2 or 3 times a week. Disappointingly, these kinds of exercise programs have led to little or no fat loss (Shaw et al. 2006). Accumulating evidence suggests that high intensity intermittent exercise (HIIE) has the potential to be an effective exercise protocol for reducing fat of overweight individuals, especially at the abdominal level (Boutcher 2011, Kessler 2012). HIIE involves brief high-intensity, anaerobic exercise followed by brief but slightly longer bouts of very low-intensity exercise.
The aim of our study was to compare the effects of 16-week steady-state exercise (SSE) program with high intensity intermittent exercise (HIIE) program on total abdominal and visceral fat mass in T2D postmenopausal women.
30 T2D postmenopausal women will be randomly assigned to SSE (n= 15) or HIIE (n= 15) group. Subjects performed two sessions by week, on bicycle, during 16 weeks.
SSE: For the SSE protocol, each subject performed 40 min at 50% MAP (maximal aerobic power) HIIE: For the HIIE protocol, each subject performed 8 s of sprinting and 12 s of turning the pedals over slowly (between 20 and 30 r.p.m.) for a maximum of 60 repeats a session.
Total body and regional fat content will be measured using dual-energy x-ray absorptiometry (DXA) before and after the intervention (4 months). The contribution of visceral fat to total abdominal fat will be determined from computed tomography (CT).
The effects of HIIE and SSE program on:
Total fat mass (and appendicular fat mass) (DXA)
Total fat free mass (and appendicular fat free mass) (DXA)
Glycemic profile (plasma HbA1c, plasma glucose)
Lipid profile (TG, HDL, LDL, total cholesterol)
Food behavior after training (questionnaires)
will also be compared.
Gaussian distribution of the data will be tested by the Kolmogorov-Smirnov test. Data will be presented as mean ± standard deviation (SD). Comparisons between groups will be made with Mann & Whitney U test or ANOVA when appropriate. Relationships between data will be assessed by Pearson correlation. Significance will be accepted at the p<0.05 level. Statistical procedures will be performed using Statistica.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Overweight (BMI > 25), Postmenopausal Women
Keywords
intermittent sprinting, abdominal fat mass, type 2 diabetes, postmenopausal women
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
steady-state exercise (SSE)
Arm Type
Experimental
Arm Description
The aim of our study was to compare the effects of 16-week steady-state exercise (SSE) program with high intensity intermittent exercise (HIIE) program on total abdominal and visceral fat mass in T2D postmenopausal women.
Arm Title
high intensity intermittent exercise (HIIE)
Arm Type
Other
Arm Description
The aim of our study was to compare the effects of 16-week steady-state exercise (SSE) program with high intensity intermittent exercise (HIIE) program on total abdominal and visceral fat mass in T2D postmenopausal women.
Intervention Type
Procedure
Intervention Name(s)
Physical activity programs steady-state exercise (SSE) program
Intervention Description
The aim of our study was to compare the effects of 16-week steady-state exercise (SSE) program with high intensity intermittent exercise (HIIE) program on total abdominal and visceral fat mass in T2D postmenopausal women.
Intervention Type
Procedure
Intervention Name(s)
Physical activity programs high intensity intermittent exercise (HIIE)
Primary Outcome Measure Information:
Title
loss of abdominal fat mass (g)
Description
Total abdominal fat mass will be measured in all patients from DXA using the methodology of Martin et Jensen (1991; L1-L2 to pubic rami) before (baseline, T0) and after 4 months of training (T4).
Time Frame
at baseline (T0) and after 4 months of training (T4)
Secondary Outcome Measure Information:
Title
Change from baseline in visceral fat mass (g)
Description
calculated from computer tomography, Sottier et al. 2013
Time Frame
at baseline (T0) and after 4 months of training (T4)
Title
Change from baseline in total fat mass (g) determined from DXA
Description
determined from DXA
Time Frame
at baseline (T0) and after 4 months of training (T4)
Title
Change from baseline in total fat free mass (g) determined from DXA
Description
determined from DXA
Time Frame
at baseline (T0) and after 4 months of training (T4)
Title
Change from baseline in glycemic profile (plasma HbA1c and plasma glucose measurements)
Description
plasma HbA1c and plasma glucose measurements
Time Frame
at T0 and after 4 months of training (T4)
Title
Change from baseline in lipid profile (plasma TG, HDL, LDL and total cholesterol measurements)
Description
plasma TG, HDL, LDL and total cholesterol measurements
Time Frame
at baseline (T0) and after 4 months of training (T4)
Title
Change from baseline in food behavior after training (visual analog scale from Flint et al. 2000)
Description
visual analog scale from Flint et al. 2000
Time Frame
at baseline (T0) and after 4 months of training (T4)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
82 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
postmenopausal women (55- 82 years)
T2D
BMI ≥ 25 and < 40
able to follow an exercise protocol
eating behavior and physical activity stable since at least 3 month
Exclusion Criteria:
- subject not able to perform exercise after medical examination
subject not able to perform bicycle exercise (pains)
chronic infection
use of β-blocker
medical treatment that could interfere with the different outcome measures
Hormonal Replacement Therapy (HRT)
regular consumption of alcohol
refusal to sign the consent form
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick LACARIN
Phone
04 73 75 11 95
Email
placarin@chu-clermontferrand.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martine DUCLOS
Organizational Affiliation
CHU de Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Clermont Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
12. IPD Sharing Statement
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HIIE and Abdominal Fat Mass in DT2 Postmenopausal Women
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