HIIE and Abdominal Fat Mass in DT2 Postmenopausal Women

NCT02352246 | Unknown

• 1 other identifier: CHU-0220
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes; Overweight (BMI > 25); Postmenopausal Women

Keywords

intermittent sprinting; abdominal fat mass; type 2 diabetes; postmenopausal women

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (6)

• Change from baseline in visceral fat mass (g)

  at baseline (T0) and after 4 months of training (T4)

• Change from baseline in total fat mass (g) 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

  at baseline (T0) and after 4 months of training (T4)

• Change from baseline in glycemic profile (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)

  at baseline (T0) and after 4 months of training (T4)

Study Arms (2)

steady-state exercise (SSE)

EXPERIMENTAL

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

high intensity intermittent exercise (HIIE)

OTHER

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)

Interventions

Physical activity programs steady-state exercise (SSE) program PROCEDURE

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.

steady-state exercise (SSE)

Physical activity programs high intensity intermittent exercise (HIIE) PROCEDURE

high intensity intermittent exercise (HIIE)

Eligibility Criteria

• Age: 55 Years - 82 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• Laboratory of metabolic adaptation to exercise under Physiological and Physiopathological conditions (AME2): collaborator

Study Sites (1)

Chu Clermont Ferrand

Clermont-Ferrand, 63003, France

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Overweight

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Martine DUCLOS

  CHU de Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick LACARIN

CONTACT

04 73 75 11 95; placarin@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2015
• First Posted: February 2, 2015
• Study Start: February 1, 2015
• Primary Completion: July 1, 2017
• Study Completion: December 1, 2017
• Last Updated: February 2, 2015

Record last verified: 2015-01

Locations

FR (1)