Type 2 DiabetesNCT02352246
HIIE and Abdominal Fat Mass in DT2 Postmenopausal Women
A study testing Physical activity programs steady-state exercise (SSE) program and Physical activity programs high intensity intermittent exercise (HIIE) in people with Type 2 Diabetes and Overweight (BMI > 25), run by University Hospital, Clermont-Ferrand at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 55 to 82 years, women only
- Conditions the study is for
- Type 2 Diabetes, Overweight (BMI > 25), Postmenopausal Women
- What is being tested?
- Physical activity programs steady-state exercise (SSE) program and Physical activity programs high intensity intermittent exercise (HIIE)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2015to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 82 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- - 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Type 2 Diabetes, Overweight (BMI > 25), Postmenopausal Women
- Being tested
- Physical activity programs steady-state exercise (SSE) program, Physical activity programs high intensity intermittent exercise (HIIE)
- Keywords
- intermittent sprinting, abdominal fat mass, type 2 diabetes, postmenopausal women
- Medical subject headings
- Diabetes Mellitus, Type 2, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity programs steady-state exercise (SSE) programProcedure or surgery
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)Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Physical activity programs high intensity intermittent exercise (HIIE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: at baseline (T0) and after 4 months of training (T4)
Secondary outcomes (6)
Change from baseline in visceral fat mass (g)
calculated from computer tomography, Sottier et al. 2013
Measured: at baseline (T0) and after 4 months of training (T4)
Change from baseline in total fat mass (g) determined from DXA
determined from DXA
Measured: at baseline (T0) and after 4 months of training (T4)
Change from baseline in total fat free mass (g) determined from DXA
determined from DXA
Measured: at baseline (T0) and after 4 months of training (T4)
Change from baseline in glycemic profile (plasma HbA1c and plasma glucose measurements)
plasma HbA1c and plasma glucose measurements
Measured: at T0 and after 4 months of training (T4)
Change from baseline in lipid profile (plasma TG, HDL, LDL and total cholesterol measurements)
plasma TG, HDL, LDL and total cholesterol measurements
Measured: 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)
visual analog scale from Flint et al. 2000
Measured: at baseline (T0) and after 4 months of training (T4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionJul 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Laboratory of metabolic adaptation to exercise under Physiological and Physiopathological conditions (AME2)
- Responsible party
- Sponsor
- Investigators
- Martine DUCLOS, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02352246
- Sponsor's protocol ID
- CHU-0220
- Status last verified
- Jan 2015
- First submitted
- 19 Jan 2015
- Last updated
- 2 Feb 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High-Intensity Intermittent Exercise on Abdominal Fat Mass in Type 2 Diabetes Postmenopausal Women.
- ClinicalTrials.gov ID
- NCT02352246
- Acronym / sponsor ID
- CHU-0220
- Conditions
- Type 2 Diabetes, Overweight (BMI > 25), Postmenopausal Women
- Keywords
- intermittent sprinting, abdominal fat mass, type 2 diabetes, postmenopausal women
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Laboratory of metabolic adaptation to exercise under Physiological and Physiopathological conditions (AME2)
- Study start
- Feb 2015
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 2 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| steady-state exercise (SSE) | Experimental | Procedure: Physical activity programs steady-state exercise (SSE) programThe 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) | Other | Procedure: Physical activity programs 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. |
Who may qualify
- Ages
- 55 to 82 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activity programs steady-state exercise (SSE) programThe 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 or surgery | steady-state exercise (SSE) |
| Physical activity programs high intensity intermittent exercise (HIIE) | Procedure or surgery | high intensity intermittent exercise (HIIE) |
Primary outcome
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).
6 secondary outcomes
Change from baseline in visceral fat mass (g)
Time frame: 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)
Change from baseline in total fat free mass (g) determined from DXA
Time frame: 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)
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)
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martine DUCLOS principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity programs steady-state exercise (SSE) program and Physical activity programs high intensity intermittent exercise (HIIE) in people with Type 2 Diabetes and Overweight (BMI > 25), run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick LACARIN (04 73 75 11 95, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
loss of abdominal fat mass (g) (time frame: at baseline (T0) and after 4 months of training (T4)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2015.