HIIE and Abdominal Fat Mass in DT2 Postmenopausal Women

January 30, 2015 updated by: University Hospital, Clermont-Ferrand

Effect of High-Intensity Intermittent Exercise on Abdominal Fat Mass in Type 2 Diabetes Postmenopausal Women.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63003
        • CHU Clermont Ferrand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 82 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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.
OTHER: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
at baseline (T0) and after 4 months of training (T4)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at baseline (T0) and after 4 months of training (T4)
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
at baseline (T0) and after 4 months of training (T4)
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
at baseline (T0) and after 4 months of training (T4)
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
at T0 and after 4 months of training (T4)
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
at baseline (T0) and after 4 months of training (T4)
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
at baseline (T0) and after 4 months of training (T4)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Collaborators

Laboratory of metabolic adaptation to exercise under Physiological and Physiopathological conditions (AME2)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (ANTICIPATED)

July 1, 2017

Study Completion (ANTICIPATED)

December 1, 2017

Study Registration Dates

First Submitted

January 19, 2015

First Submitted That Met QC Criteria

January 30, 2015

First Posted (ESTIMATE)

February 2, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

February 2, 2015

Last Update Submitted That Met QC Criteria

January 30, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHU-0220

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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