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HIIE and Abdominal Fat Mass in DT2 Postmenopausal Women

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ClinicalTrials.gov Identifier: NCT02352246
Recruitment Status : Unknown
Verified January 2015 by University Hospital, Clermont-Ferrand.
Recruitment status was:  Not yet recruiting
First Posted : February 2, 2015
Last Update Posted : February 2, 2015
Sponsor:
Collaborator:
Laboratory of metabolic adaptation to exercise under Physiological and Physiopathological conditions (AME2)
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

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.


Condition or disease Intervention/treatment Phase
Type 2 Diabetes Overweight (BMI > 25) Postmenopausal Women Procedure: Physical activity programs steady-state exercise (SSE) program Procedure: Physical activity programs high intensity intermittent exercise (HIIE) Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Effect of High-Intensity Intermittent Exercise on Abdominal Fat Mass in Type 2 Diabetes Postmenopausal Women.
Study Start Date : February 2015
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: steady-state exercise (SSE)
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.
Procedure: Physical activity programs steady-state exercise (SSE) program
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.

high intensity intermittent exercise (HIIE)
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.
Procedure: Physical activity programs high intensity intermittent exercise (HIIE)



Primary Outcome Measures :
  1. loss of abdominal fat mass (g) [ Time Frame: at baseline (T0) and after 4 months of training (T4) ]
    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 :
  1. Change from baseline in visceral fat mass (g) [ Time Frame: at baseline (T0) and after 4 months of training (T4) ]
    calculated from computer tomography, Sottier et al. 2013

  2. Change from baseline in total fat mass (g) determined from DXA [ Time Frame: at baseline (T0) and after 4 months of training (T4) ]
    determined from DXA

  3. Change from baseline in total fat free mass (g) determined from DXA [ Time Frame: at baseline (T0) and after 4 months of training (T4) ]
    determined from DXA

  4. Change from baseline in glycemic profile (plasma HbA1c and plasma glucose measurements) [ Time Frame: at T0 and after 4 months of training (T4) ]
    plasma HbA1c and plasma glucose measurements

  5. Change from baseline in lipid profile (plasma TG, HDL, LDL and total cholesterol measurements) [ Time Frame: at baseline (T0) and after 4 months of training (T4) ]
    plasma TG, HDL, LDL and total cholesterol measurements

  6. Change from baseline in food behavior after training (visual analog scale from Flint et al. 2000) [ Time Frame: at baseline (T0) and after 4 months of training (T4) ]
    visual analog scale from Flint et al. 2000



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Ages Eligible for Study:   55 Years to 82 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02352246


Contacts
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Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr

Locations
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France
Chu Clermont Ferrand
Clermont-Ferrand, France, 63003
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Laboratory of metabolic adaptation to exercise under Physiological and Physiopathological conditions (AME2)
Investigators
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Principal Investigator: Martine DUCLOS CHU de Clermont-Ferrand

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Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT02352246     History of Changes
Other Study ID Numbers: CHU-0220
First Posted: February 2, 2015    Key Record Dates
Last Update Posted: February 2, 2015
Last Verified: January 2015

Keywords provided by University Hospital, Clermont-Ferrand:
intermittent sprinting
abdominal fat mass
type 2 diabetes
postmenopausal women

Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Overweight
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Body Weight
Signs and Symptoms