Metabolic SyndromeRESOLVE+10NCT04453098
Results at 10 Years of the RESOLVE Study (RESOLVE+10)
A study testing 3-week residential program based on a tryptic (diet, in people with Metabolic Syndrome, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
10-year effect of a lifestyle intervention program (exercise, sedentary lifestyle and dietary diet) on abdominal visceral adipose tissue (primary endpoint of the RESOLVE study 10 years ago): influence of kinetics abdominal visceral adipose tissue loss in the first year of follow-up on abdominal visceral adipose tissue… Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- 3-week residential program based on a tryptic (diet,
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2020to Jul 2021
- 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 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients and healthy controls included in the RESOLVE study
Who cannot join
- refusal of participation
Trial locations and contacts
1 site in 1 country.
France1 site
CHU de Clermont-Ferrand
Clermont-Ferrand, 63000
Lise Laclautre, +33473754963, promo_interne_drci@chu-clermontferrand.fr
Frédéric Dutheil
About this study
Official title: Results at 10 Years of the RESOLVE Study (REverse Metabolic SyndrOme by Lifestyle and Various Exercise)
10-year effect of a lifestyle intervention program (exercise, sedentary lifestyle and dietary diet) on abdominal visceral adipose tissue (primary endpoint of the RESOLVE study 10 years ago): influence of kinetics abdominal visceral adipose tissue loss in the first year of follow-up on abdominal visceral adipose tissue at 10 years
Read the detailed description
The RESOLVE + 10 protocol was design to provide a 10-year effect of a lifestyle intervention program (exercise, sedentary lifestyle and dietary diet) on abdominal visceral adipose tissue.
In the present protocol, parameters are measured just once, during 3 hours, to compared the results with those of the protocol RESOLVE (5 measurement times over a year 10 years ago: before the thermal modification program of the lifestyle ( exercise, sedentary lifestyle and diet) of 3 weeks (D0), after the thermal program (D21), at the 3rd month (M3), 6th month (M6) and 12th month of follow-up (M12), to which was matched a healthy control group).
Statistical analysis will be performed using Stata software (version 13; Stata-Corp, College Station, Tex., USA). All statistical tests will be two-sided and p inferior to 0.05 will be considered significant. Qualitative variables will be described in terms of numbers and proportions. Quantitative variables will be described in terms of numbers, mean standard deviation or median according to statistical distribution (normality studied using Shapiro-Wilk test). Graphic representations will be complete presentations of results. Comparisons between patients and controls, concerning loss of abdominal visceral adipose tissue at 10 years, will be performed using Student t-test or Mann-Whitney test if the assumptions of anova are not met (normality and homoscedasticity analyzed using Fisher-Snedecor test). The results will be expressed as effect-size and 95 percent confidence intervals. The primary analysis should be completed by multivariable analysis (linear regression with logarithmic transformation of dependent outcome if necessary) considering an adjustment on covariates fixed according to univariate results and clinical relevance. The results will be expressed as regression coefficients and 95percent confidence intervals. Furthermore, the abdominal visceral adipose tissue loss kinetics in the first year of follow-up will be considered an independent variable and treated as a functional variable. The intra-group comparisons (for patients and for controls) will be performed using paired statistical tests: paired t-test or Wilcoxon test. The results will be expressed as effect-size and 95 percent confidence intervals. Comparisons between independent groups will be done similarly as presented previously for other quantitative outcomes (body composition, quality of life, skin conductance, etc.). Multivariable analyses will be applied similarly as described previously. The comparisons concerning categorical variables will be realized using Chi-squared or when appropriate Fischer-exact test. The relations between quantitative outcomes will be analyzed using correlation coefficients (Pearson or Spearman according to statistical distribution). Considering the several multiple comparisons, a correction of the type I error will be applied (Sidak's correction).
- Conditions
- Metabolic Syndrome
- Being tested
- 3-week residential program based on a tryptic (diet,
- Keywords
- physical activity, spa residential lifestyle program, prevention
- Medical subject headings
- Metabolic Syndrome, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3-week residential program based on a tryptic (diet,Behavioural
3-week residential program based on a tryptic (diet, exercise, education). The three weeks intervention was followed by a 1-year at-home follow-up.
In the original protocol, participants were involved in a 3-week residential program based on a tryptic (diet, exercise, education).
| Study group | Role | What they receive |
|---|---|---|
| Re group | Experimental | high-Resistance-moderate-endurance, participants performed 10 repetitions at 70% of one maximal repetition in resistance and 30% of VO2-peak for endurance training Receives: Behavioral: 3-week residential program based on a tryptic (diet, |
| rE group | Experimental | moderate-resistance (30%) - high-Endurance (70%) Receives: Behavioral: 3-week residential program based on a tryptic (diet, |
| re group | Experimental | moderate-resistance (30%) - moderate-endurance (30%). Receives: Behavioral: 3-week residential program based on a tryptic (diet, |
| control group | No intervention | no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abdominal visceral adipose tissue loss, a primary cardiovascular risk (CVR) factor, highly related to morbidity and mortality
to assess the ability of a lifestyle program in decreasing abdominal visceral fat, one of the major health-related factor It will be assessed from dual-energy X-ray absorptiometry
Measured: Year 10
Secondary outcomes (68)
weight
measured in kilogramms
Measured: Year 10
systolic blood pressure
measured in millimeter of mercure
Measured: Year 10
diastolic blood pressure
measured in millimeter of mercure
Measured: Year 10
Waist circumference
measured in centimeter
Measured: Year 10
heart rate
measured in battment per minutes
Measured: Year 10
Muscle mass
measured using Impedancemeter, Densitometry x-ray absorption, Peripheral quantitative computed tomography (pQCT) and Quantitative ultrasounds (QUS)
Measured: Year 10
fat mass
measured using Impedancemeter, Densitometry x-ray absorption, Peripheral quantitative computed tomography (pQCT) and Quantitative ultrasounds (QUS)
Measured: Year 10
bone structure
measured using Impedancemeter, Densitometry x-ray absorption, Peripheral quantitative computed tomography (pQCT) and Quantitative ultrasounds (QUS)
Measured: Year 10
Epicardial adipose tissue
measures of epicardial adipose tissue using Magnetic resonance imaging (MRI) and echocardiography
Measured: Year 10
myocardial triglycerides
measures of myocardial triglycerides using MRI
Measured: Year 10
cardiac remodeling and function
measures cardiac remodeling and function using MRI and echocardiography)
Measured: Year 10
Depression
Assessing depression using Hospital anxiety and depression scale- HAD. It's a 14-item questionnaire about frequency of perception about anxious (HAD-A: 7 items) and depressive (HAD-D: 7 items) symptoms. Items are made of a 4-point scale frequency of symptoms, varying from "never" to "always". Scores higher than 8 for HAD-A or HAD-D mean a possible symptomatology, and scores higher than 11 mean a clear and proper diagnostic of depressive or anxious disorder.
Measured: Year 10
anxiety
Assessing anxiety using State and trait anxiety inventory which consists of separate self-report scales measuring to distinct anxiety concepts: state anxiety and trait anxiety. Both state and trait anxiety are explored by a 20-item questionnaire made of a 4-point scale from "never" to "always".
Measured: Year 10
General health
Assessing general health using General Health Questionnaire with 36 items (SF-36)
Measured: Year 10
Stress
Assessing stress using visual analog scale of 100 mm, ranging from very low (0) to very high (100).
Measured: Year 10
Fatigue
Assessing fatigue using visual analog scale of 100 mm, ranging from very low (0) to very high (100).
Measured: Year 10
Sleep
Assessing sleep using visual analog scale of 100 mm, ranging from very low (0) to very high (100).
Measured: Year 10
Burnout
Assessing burnout using Maslach Burnout Inventory, composed of 22 items designed to assess the three components of the burn-out syndrome: emotional exhaustion (9 items), depersonalization (5 items) and reduced personal accomplishment (8 items). Items are made of a 7-point scale frequency of feelings, varying from "never" to "every day". The scores for each component of the burn-out syndrome are considered separately and are not combined into a single total score. If desired for participant feedback, each score can be coded as low, average, or high.
Measured: Year 10
Mindfulness
Assessing mindfulness using Freiburg Mindfulness Inventory a consistent and reliable scale evaluating several important aspects of mindfulness. Mindfulness has been described as a non-elaborative, non-judgmental present-centred awareness in which each thought, feeling or sensation that arises in the attention field is acknowledged and accepted as it is. Mindfulness appears as an attribute of consciousness long believed to promote well-being. Each self-descriptive statement of the FMI is evaluated using a four-point Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree)
Measured: Year 10
Coping strategy
Assessing coping using Brief COPE Questionnaire made to evaluate self-perceived reaction to a particular situation. The 28 items of the BCQ explore the 14 different theoretically identified coping responses (with two items for each of the measured coping strategies): self-distraction, active coping, denial, substance use, use of emotional support, use of instrumental support, Behavioral disengagement, venting, positive reframing, planning, humor, acceptance, religion, and self-blame. Items of BCQ are scored on a four-point Likert-type scale, ranging from 1 = strongly disagree to 4 = strongly agree.
Measured: Year 10
Emotions
Assessing emotions using Emotion Regulation Questionnaire a 10-item scale designed to measure respondents' tendency to regulate their emotions in two ways: 1) cognitive reappraisal and 2) expressive suppression. Respondents answer each item on a 7-point
Measured: Year 10
Perception of work
Assessing perception of work using Job Content Questionnaire of Karasek which assessed job demands, job control and social support through 26 items. The questionnaire measures 9 items of job demands, 9 items of job control and 8 items of social support. Items are scored on a four-point Likert-type scale, ranging from 1 = strongly disagree to 4 = strongly agree. Among the 26 items, 5 negative statements require reverse scoring. From French data, the job strain threshold is set for a demands score higher than 20 and a control score lower than 71; the isostrain threshold is determined from a combining score of job strain and social support lower than 24. We would ask the participants to fulfil the questionnaire from memories that they keep of their work.
Measured: Year 10
Self-efficacy
Assessing self-efficacy using Perceived self-efficacy scale created to assess a general sense of perceived self-efficacy with the aim in mind to predict coping with daily hassles as well as adaptation after experiencing all kinds of stressful life events. Responses are made on a 4-point scale for the 10 items (from "false" to "true"). The final composite score (ranged from 10 to 40) is obtained by summing up the responses to all 10 items. An example of item is "I am confident that I could deal efficiently with unexpected events".
Measured: Year 10
Addiction
Assessing addiction to work using Work Addiction Risk test (WART). The WART is a self-administered test with 25 statements for which the answers are scored 1-never true to 4-always true [20,26]. Respondents read the statements and mark their answers to describe their work habits [19,27]. The total score is the sum of the responses to the items-25 to 100-and the higher the score, the more one is considered addicted to work [18,21]. Scores from 25 to 56 were defined as "at low-risk of work addiction"; 57 to 66 as "at medium-risk of work addiction", and from 67 to 100 as "at high-risk of work addiction".
Measured: Year 10
Alexithymia
Assessing alexithymia using Toronto Alexithymia Scale For this scale, a three-factor structure was proposed: difficulty identifying feelings, difficulty describing feelings and externally oriented thinking. Responses are made on a 5-point scale from "strongly agree" to "strongly disagree".
Measured: Year 10
Illness perception
Assessing illness perception using Brief Illness Perception Questionnaire (B-IPQ), adapted for stress at work). It's a self-questionnaire comprising an 11-point scale, including 8 items measuring cognitive and emotional illness perceptions (consequences, timeline, personal control, treatment control, symptoms, coherence, illness concern and negative emotions). The total score is calculated by averaging all items (after reversed some items). A high score meant that diabetes was perceived as a threat.
Measured: Year 10
Metacognition
Assessing metacognition using MetaCognition Questionnaire. It is a 30-item questionnaire made of 5-point scales. The MCQ-30 is structured in five factors: cognitive confidence, positive beliefs about worry, cognitive self-consciousness, negative beliefs about uncontrollability of thoughts and danger, and beliefs about need to control thoughts.
Measured: Year 10
Time perception
Assessing time perception using Zimbardo Time Perspective Inventory, a self-reported questionnaire comprising 56 items. Responses are made on a 5-point scale from "very uncharacteristic" to "very characteristic". It explores 3 temporalities and 5 dimensions.
Measured: Year 10
Life style
Assessing factors regarding lifestyle are related to smoking, alcohol, coffee, food intake (questionnaires), and physical activity (Recent Physical Activity Questionnaire)
Measured: Year 10
Treatment perception
Assessing factors regarding psychology and treatment are related to perception of treatment (Beliefs about Medicines Questionnaire), adherence to treatment (Visual analog scales from never to always), barriers to treatment (QUILAM) and treatment satisfaction (treatment SATisfaction with MEDicines Questionnaire).
Measured: Year 10
questionnaires used 10 years ago
Understanding and knowledge about the metabolic syndrome (4 items), comparative optimism (4 items), motivation to eat healthy (16 items) and motivation to practise physical activity (16 items).
Measured: Year 10
Cholesterol
Blood analyses on HDLc and LDL-cholesterol
Measured: Year 10
HbA1c
Blood analyses on HbA1c
Measured: Year 10
Triglycerides (TG)
Blood analyses on Triglycerides (TG)
Measured: Year 10
Cortisol
Blood analyses on Cortisol
Measured: Year 10
DHEAS
Blood analyses on DHEAS
Measured: Year 10
Leptin
Blood analyses on Leptin
Measured: Year 10
BDnF
Blood analyses on BDnF
Measured: Year 10
Cytokines
Blood analyses on Pro-inflammatory Cytokines: IL-1β, IL-6, IL-1, TNFα, NPY
Measured: Year 10
Telomeres length
Blood analyses on Telomeres length
Measured: Year 10
Genetic polymorphisms related to stress
Polymorphism of the angiotensin converting enzyme and Polymorphism of the serotonin are measured by Blood cells
Measured: Year 10
carotid intima-media thickness
Assessing on carotid intima-media thickness by high-resolution B-mode ultrasound.
Measured: Year 10
blood flow velocity
Assessing on blood flow velocity by laser speckle contrast imaging (LSCI) and microvascular perfusion by laser-doppler flowmetry (LDF), flowmotion and Iontophoresis procedure.
Measured: Year 10
microvascular perfusion
Assessing microvascular perfusion by laser-doppler flowmetry (LDF).
Measured: Year 10
flowmotion
Assessing flowmotion
Measured: Year 10
iontophoresis
Assessing iontophoresis procedure
Measured: Year 10
heart rate variability
Assessing heart rate variability by Holter
Measured: Year 10
skin conductance
Assessing skin conductance by Wristband electrodes - Empatica 4.
Measured: Year 10
Quantification of liver steatosis and fibrosis
Liver steatosis by MRI, fibroscanner (ultrasonic attenuation) and Aixplorer (Lipersonic Imagine®).
Measured: Year 10
Quantification of liver fibrosis
Liver fibrosis by fibroscanner (liver stiffness) and fibrotest
Measured: Year 10
Vo2max
Assessing factors regarding fitness are related to Vo2max (maximal exercise test)
Measured: Year 10
Fitness
Assessing factors regarding fitness are related to 6-minutes walking test.
Measured: Year 10
strength
Assessing factors regarding fitness are related to strength
Measured: Year 10
leptin variation
Blood analyses on leptin
Measured: Year 10
ghrelin variation
Blood analyses on ghrelin
Measured: Year 10
NPY variation
Blood analyses on NPY
Measured: Year 10
adiponectin variation
Blood analyses on adiponectin
Measured: Year 10
Evaluation of CCK level
Blood analyses on CCK
Measured: Year 10
Evaluation of VEGF level
Blood analyses on VEGF
Measured: Year 10
Evaluation of PAI1 level
Blood analyses on PAI1
Measured: Year 10
insulin level
Blood analyses on insulin
Measured: Year 10
HbA1c level
Blood analyses on HbA1c
Measured: Year 10
blood glucose level
Blood analyses on blood glucose
Measured: Year 10
albumin level
Blood analyses on blood albumin
Measured: Year 10
transthyretin level
Blood analyses on transthyretin
Measured: Year 10
Homeostasis
Blood analyses on Homeostasis (Fibroblast growth factor 23)
Measured: Year 10
Osteoresorption
Blood analyses on Osteoresorption (C-terminal Telopeptide of Type I collagen)
Measured: Year 10
Osteoformation
Blood analyses on Osteoformation (decarboxylated osteocalcine and BSAP)
Measured: Year 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2020
- Study startSep 2020 (estimated)
- Primary completionJul 2021 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- participants receive an intervention throughout the protocol
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Université d'Auvergne, LaPSCo laboratory, Physiological and Psychosocial Stress" team, UMR CNRS 6024, Clermont-Ferrand, France, LaPEC laboratory (EA 4278), University of Avignon, Avignon, France
- Responsible party
- Sponsor
- Investigators
- Frédéric Dutheil, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04453098
- Sponsor's protocol ID
- AOI 2018 DUTHEIL
- Other IDs
- 2019-A01016-51
- Acronym
- RESOLVE+10
- Status last verified
- Jun 2020
- First submitted
- 22 Jun 2020
- Last updated
- 1 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Results at 10 Years of the RESOLVE Study (REverse Metabolic SyndrOme by Lifestyle and Various Exercise)
- ClinicalTrials.gov ID
- NCT04453098
- Acronym / sponsor ID
- RESOLVE+10 / AOI 2018 DUTHEIL
- Conditions
- Metabolic Syndrome
- Keywords
- physical activity, spa residential lifestyle program, prevention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Université d'Auvergne, LaPSCo laboratory, Physiological and Psychosocial Stress" team, UMR CNRS 6024, Clermont-Ferrand, France, LaPEC laboratory (EA 4278), University of Avignon, Avignon, France
- Study start
- Sep 2020 (estimated)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 1 Jul 2020 (actual)
- 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.
10-year effect of a lifestyle intervention program (exercise, sedentary lifestyle and dietary diet) on abdominal visceral adipose tissue (primary endpoint of the RESOLVE study 10 years ago): influence of kinetics abdominal visceral adipose tissue loss in the first year of follow-up on abdominal visceral adipose tissue at 10 years
Detailed description
The RESOLVE + 10 protocol was design to provide a 10-year effect of a lifestyle intervention program (exercise, sedentary lifestyle and dietary diet) on abdominal visceral adipose tissue.
In the present protocol, parameters are measured just once, during 3 hours, to compared the results with those of the protocol RESOLVE (5 measurement times over a year 10 years ago: before the thermal modification program of the lifestyle ( exercise, sedentary lifestyle and diet) of 3 weeks (D0), after the thermal program (D21), at the 3rd month (M3), 6th month (M6) and 12th month of follow-up (M12), to which was matched a healthy control group).
Statistical analysis will be performed using Stata software (version 13; Stata-Corp, College Station, Tex., USA). All statistical tests will be two-sided and p inferior to 0.05 will be considered significant. Qualitative variables will be described in terms of numbers and proportions. Quantitative variables will be described in terms of numbers, mean standard deviation or median according to statistical distribution (normality studied using Shapiro-Wilk test). Graphic representations will be complete presentations of results. Comparisons between patients and controls, concerning loss of abdominal visceral adipose tissue at 10 years, will be performed using Student t-test or Mann-Whitney test if the assumptions of anova are not met (normality and homoscedasticity analyzed using Fisher-Snedecor test). The results will be expressed as effect-size and 95 percent confidence intervals. The primary analysis should be completed by multivariable analysis (linear regression with logarithmic transformation of dependent outcome if necessary) considering an adjustment on covariates fixed according to univariate results and clinical relevance. The results will be expressed as regression coefficients and 95percent confidence intervals. Furthermore, the abdominal visceral adipose tissue loss kinetics in the first year of follow-up will be considered an independent variable and treated as a functional variable. The intra-group comparisons (for patients and for controls) will be performed using paired statistical tests: paired t-test or Wilcoxon test. The results will be expressed as effect-size and 95 percent confidence intervals. Comparisons between independent groups will be done similarly as presented previously for other quantitative outcomes (body composition, quality of life, skin conductance, etc.). Multivariable analyses will be applied similarly as described previously. The comparisons concerning categorical variables will be realized using Chi-squared or when appropriate Fischer-exact test. The relations between quantitative outcomes will be analyzed using correlation coefficients (Pearson or Spearman according to statistical distribution). Considering the several multiple comparisons, a correction of the type I error will be applied (Sidak's correction).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- participants receive an intervention throughout the protocol
| Arm | Type | Receives |
|---|---|---|
| Re group | Experimental | Behavioral: 3-week residential program based on a tryptic (diet,high-Resistance-moderate-endurance, participants performed 10 repetitions at 70% of one maximal repetition in resistance and 30% of VO2-peak for endurance training |
| rE group | Experimental | Behavioral: 3-week residential program based on a tryptic (diet,moderate-resistance (30%) - high-Endurance (70%) |
| re group | Experimental | Behavioral: 3-week residential program based on a tryptic (diet,moderate-resistance (30%) - moderate-endurance (30%). |
| control group | No intervention | –no intervention |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients and healthy controls included in the RESOLVE study
Key exclusion criteria (1 listed)
- refusal of participation
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 |
|---|---|---|
| 3-week residential program based on a tryptic (diet,3-week residential program based on a tryptic (diet, exercise, education). The three weeks intervention was followed by a 1-year at-home follow-up. In the original protocol, participants were involved in a 3-week residential program based on a tryptic (diet, exercise, education). | Behavioural | Re group, rE group, re group |
Primary outcome
Abdominal visceral adipose tissue loss, a primary cardiovascular risk (CVR) factor, highly related to morbidity and mortality
Time frame: Year 10
to assess the ability of a lifestyle program in decreasing abdominal visceral fat, one of the major health-related factor It will be assessed from dual-energy X-ray absorptiometry
68 secondary outcomes
weight
Time frame: Year 10
systolic blood pressure
Time frame: Year 10
diastolic blood pressure
Time frame: Year 10
Waist circumference
Time frame: Year 10
heart rate
Time frame: Year 10
Muscle mass
Time frame: Year 10
fat mass
Time frame: Year 10
bone structure
Time frame: Year 10
Epicardial adipose tissue
Time frame: Year 10
myocardial triglycerides
Time frame: Year 10
cardiac remodeling and function
Time frame: Year 10
Depression
Time frame: Year 10
anxiety
Time frame: Year 10
General health
Time frame: Year 10
Stress
Time frame: Year 10
Fatigue
Time frame: Year 10
Sleep
Time frame: Year 10
Burnout
Time frame: Year 10
Mindfulness
Time frame: Year 10
Coping strategy
Time frame: Year 10
Emotions
Time frame: Year 10
Perception of work
Time frame: Year 10
Self-efficacy
Time frame: Year 10
Addiction
Time frame: Year 10
Alexithymia
Time frame: Year 10
Illness perception
Time frame: Year 10
Metacognition
Time frame: Year 10
Time perception
Time frame: Year 10
Life style
Time frame: Year 10
Treatment perception
Time frame: Year 10
questionnaires used 10 years ago
Time frame: Year 10
Cholesterol
Time frame: Year 10
HbA1c
Time frame: Year 10
Triglycerides (TG)
Time frame: Year 10
Cortisol
Time frame: Year 10
DHEAS
Time frame: Year 10
Leptin
Time frame: Year 10
BDnF
Time frame: Year 10
Cytokines
Time frame: Year 10
Telomeres length
Time frame: Year 10
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2020.
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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.
Frédéric Dutheil 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 3-week residential program based on a tryptic (diet, in people with Metabolic Syndrome, 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 1 inclusion and 1 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 1 Jul 2020. 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 Lise LACLAUTRE (+33473754963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abdominal visceral adipose tissue loss, a primary cardiovascular risk (CVR) factor, highly related to morbidity and mortality (time frame: Year 10). 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 1 Jul 2020.