HIIE and Abdominal Fat Mass in DT2 Postmenopausal Women

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02352246
• Other study ID #: CHU-0220
• Status: Not yet recruiting
• Phase: N/A
• First received: January 19, 2015
• Last updated: January 30, 2015
• Start date: February 2015
• Est. completion date: December 2017

Study information

• Verified date: January 2015
• Source: University Hospital, Clermont-Ferrand
• Contact: Patrick LACARIN
• Phone: 04 73 75 11 95
• Email: placarin[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 55 Years to 82 Years

Eligibility

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 ß-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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Overweight (BMI > 25)
• Postmenopausal Women
• Type 2 Diabetes

Intervention

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.
• Physical activity programs high intensity intermittent exercise (HIIE)

Locations

Country	Name	City	State
France	Chu Clermont Ferrand	Clermont-Ferrand

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	Laboratory of metabolic adaptation to exercise under Physiological and Physiopathological conditions (AME2)

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	at baseline (T0) and after 4 months of training (T4)	Yes
Secondary	Change from baseline in visceral fat mass (g)	calculated from computer tomography, Sottier et al. 2013	at baseline (T0) and after 4 months of training (T4)	Yes
Secondary	Change from baseline in total fat mass (g) determined from DXA	determined from DXA	at baseline (T0) and after 4 months of training (T4)	Yes
Secondary	Change from baseline in total fat free mass (g) determined from DXA	determined from DXA	at baseline (T0) and after 4 months of training (T4)	Yes
Secondary	Change from baseline in glycemic profile (plasma HbA1c and plasma glucose measurements)	plasma HbA1c and plasma glucose measurements	at T0 and after 4 months of training (T4)	Yes
Secondary	Change from baseline in lipid profile (plasma TG, HDL, LDL and total cholesterol measurements)	plasma TG, HDL, LDL and total cholesterol measurements	at baseline (T0) and after 4 months of training (T4)	Yes
Secondary	Change from baseline in food behavior after training (visual analog scale from Flint et al. 2000)	visual analog scale from Flint et al. 2000	at baseline (T0) and after 4 months of training (T4)	Yes