Results at 10 Years of the RESOLVE Study (RESOLVE+10)

Metabolic Syndrome Clinical Trial

— RESOLVE+10  

Official title:

Results at 10 Years of the RESOLVE Study (REverse Metabolic SyndrOme by Lifestyle and Various Exercise)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04453098
• Other study ID #: AOI 2018 DUTHEIL
• Secondary ID: 2019-A01016-51
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2020
• Est. completion date: July 2021

Study information

• Verified date: June 2020
• Source: University Hospital, Clermont-Ferrand
• Contact: Lise LACLAUTRE
• Phone: +33473754963
• Email: promo_interne_drci[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 at 10 years

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: July 2021
• Est. primary completion date: July 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 70 Years

Eligibility

Inclusion Criteria:

• patients and healthy controls included in the RESOLVE study

Exclusion Criteria:

• refusal of participation

Related Conditions & MeSH terms

• Metabolic Syndrome
• Syndrome

Intervention

Behavioral:
• 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).

Locations

Country	Name	City	State
France	CHU de Clermont-Ferrand	Clermont-Ferrand

Sponsors (5)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	LaPEC laboratory (EA 4278), University of Avignon, Avignon, France, LaPSCo laboratory, Physiological and Psychosocial Stress" team, UMR CNRS 6024, Clermont-Ferrand, France, Université d'Auvergne, University Hospital CHU Clermont-Ferrand, 58 rue Montalembert 63003 Clermont-Ferrand, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Year 10
Secondary	weight	measured in kilogramms	Year 10
Secondary	systolic blood pressure	measured in millimeter of mercure	Year 10
Secondary	diastolic blood pressure	measured in millimeter of mercure	Year 10
Secondary	Waist circumference	measured in centimeter	Year 10
Secondary	heart rate	measured in battment per minutes	Year 10
Secondary	Muscle mass	measured using Impedancemeter, Densitometry x-ray absorption, Peripheral quantitative computed tomography (pQCT) and Quantitative ultrasounds (QUS)	Year 10
Secondary	fat mass	measured using Impedancemeter, Densitometry x-ray absorption, Peripheral quantitative computed tomography (pQCT) and Quantitative ultrasounds (QUS)	Year 10
Secondary	bone structure	measured using Impedancemeter, Densitometry x-ray absorption, Peripheral quantitative computed tomography (pQCT) and Quantitative ultrasounds (QUS)	Year 10
Secondary	Epicardial adipose tissue	measures of epicardial adipose tissue using Magnetic resonance imaging (MRI) and echocardiography	Year 10
Secondary	myocardial triglycerides	measures of myocardial triglycerides using MRI	Year 10
Secondary	cardiac remodeling and function	measures cardiac remodeling and function using MRI and echocardiography)	Year 10
Secondary	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.	Year 10
Secondary	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".	Year 10
Secondary	General health	Assessing general health using General Health Questionnaire with 36 items (SF-36)	Year 10
Secondary	Stress	Assessing stress using visual analog scale of 100 mm, ranging from very low (0) to very high (100).	Year 10
Secondary	Fatigue	Assessing fatigue using visual analog scale of 100 mm, ranging from very low (0) to very high (100).	Year 10
Secondary	Sleep	Assessing sleep using visual analog scale of 100 mm, ranging from very low (0) to very high (100).	Year 10
Secondary	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.	Year 10
Secondary	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)	Year 10
Secondary	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.	Year 10
Secondary	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	Year 10
Secondary	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.	Year 10
Secondary	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".	Year 10
Secondary	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".	Year 10
Secondary	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".	Year 10
Secondary	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.	Year 10
Secondary	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.	Year 10
Secondary	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.	Year 10
Secondary	Life style	Assessing factors regarding lifestyle are related to smoking, alcohol, coffee, food intake (questionnaires), and physical activity (Recent Physical Activity Questionnaire)	Year 10
Secondary	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).	Year 10
Secondary	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).	Year 10
Secondary	Cholesterol	Blood analyses on HDLc and LDL-cholesterol	Year 10
Secondary	HbA1c	Blood analyses on HbA1c	Year 10
Secondary	Triglycerides (TG)	Blood analyses on Triglycerides (TG)	Year 10
Secondary	Cortisol	Blood analyses on Cortisol	Year 10
Secondary	DHEAS	Blood analyses on DHEAS	Year 10
Secondary	Leptin	Blood analyses on Leptin	Year 10
Secondary	BDnF	Blood analyses on BDnF	Year 10
Secondary	Cytokines	Blood analyses on Pro-inflammatory Cytokines: IL-1ß, IL-6, IL-1, TNFa, NPY	Year 10
Secondary	Telomeres length	Blood analyses on Telomeres length	Year 10
Secondary	Genetic polymorphisms related to stress	Polymorphism of the angiotensin converting enzyme and Polymorphism of the serotonin are measured by Blood cells	Year 10
Secondary	carotid intima-media thickness	Assessing on carotid intima-media thickness by high-resolution B-mode ultrasound.	Year 10
Secondary	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.	Year 10
Secondary	microvascular perfusion	Assessing microvascular perfusion by laser-doppler flowmetry (LDF).	Year 10
Secondary	flowmotion	Assessing flowmotion	Year 10
Secondary	iontophoresis	Assessing iontophoresis procedure	Year 10
Secondary	heart rate variability	Assessing heart rate variability by Holter	Year 10
Secondary	skin conductance	Assessing skin conductance by Wristband electrodes - Empatica 4.	Year 10
Secondary	Quantification of liver steatosis and fibrosis	Liver steatosis by MRI, fibroscanner (ultrasonic attenuation) and Aixplorer (Lipersonic Imagine®).	Year 10
Secondary	Quantification of liver fibrosis	Liver fibrosis by fibroscanner (liver stiffness) and fibrotest	Year 10
Secondary	Vo2max	Assessing factors regarding fitness are related to Vo2max (maximal exercise test)	Year 10
Secondary	Fitness	Assessing factors regarding fitness are related to 6-minutes walking test.	Year 10
Secondary	strength	Assessing factors regarding fitness are related to strength	Year 10
Secondary	leptin variation	Blood analyses on leptin	Year 10
Secondary	ghrelin variation	Blood analyses on ghrelin	Year 10
Secondary	NPY variation	Blood analyses on NPY	Year 10
Secondary	adiponectin variation	Blood analyses on adiponectin	Year 10
Secondary	Evaluation of CCK level	Blood analyses on CCK	Year 10
Secondary	Evaluation of VEGF level	Blood analyses on VEGF	Year 10
Secondary	Evaluation of PAI1 level	Blood analyses on PAI1	Year 10
Secondary	insulin level	Blood analyses on insulin	Year 10
Secondary	HbA1c level	Blood analyses on HbA1c	Year 10
Secondary	blood glucose level	Blood analyses on blood glucose	Year 10
Secondary	albumin level	Blood analyses on blood albumin	Year 10
Secondary	transthyretin level	Blood analyses on transthyretin	Year 10
Secondary	Homeostasis	Blood analyses on Homeostasis (Fibroblast growth factor 23)	Year 10
Secondary	Osteoresorption	Blood analyses on Osteoresorption (C-terminal Telopeptide of Type I collagen)	Year 10
Secondary	Osteoformation	Blood analyses on Osteoformation (decarboxylated osteocalcine and BSAP)	Year 10