ADIposity and Bone Metabolism: Effects of eXercise-induced Weight Loss in Obese Adolescents (ADIBOX)

The present protocol is mainly involved in the understanding of the local interaction between the released products by fat tissue and hormones production of bone tissue. These complex interactions between adipocyte and osteocyte activities could explain the mechanisms of the body responses to the strategies of weight loss that include diet and/or physical activity program, as well as the side effects encountered by these interventions.

Adolescence is a period of development characterized by many metabolic and somatic changes that may influence weight. Weights bearing physical activities are a key factor allowing body composition changes (i.e. fat and bone tissue). The difficulties of managing weight and the onset of overweight and obesity during this very important growth spurt lead to various hormonal dysregulation. The specific mechanisms of the evolution and interactions between these two parameters (fat and bone tissue) are not yet elucidated; therefore our aim is to analyze the possible connections between fat tissue and the quality of the skeleton in order to reduce related risks of the consequence of weight loss in obese individuals.

Study Overview

• Status: Unknown
• Conditions: Obesity
• Intervention / Treatment: Radiation: weight loss

Detailed Description

The complex consequences of childhood obesity represent major concerns in most developed countries, largely contributing to metabolic complications with costly repercussions for the burden of disease. The burden is exemplified by high prevalence rates of overweight or obesity.

The ADIBOX protocol was designed to provide a better understanding of the bone-adipocyte cross-talk in adolescents with obesity and the effects of physical activity-induced weight loss on this cross-talk.

Obesity effectively leads to hormonal alterations favoring the accumulation of fat mass and loss of bone mass. Advancing the knowledge of the complex interactions between adipocyte and osteocyte activities may contribute to the mechanistic understanding of the body's responses to weight loss during adolescence and prevent cardiovascular risk. Indeed, the adipose-bone tissue cross-talk has been recently linked with cardiovascular diseases. Similarly as adipose tissue, released-products from bone tissue may act directly or indirectly on cardiovascular risk and diseases.

The ADIBOX study, a 40 weeks longitudinal study (LS) with repeated measures on four occasions (baseline and every fourteen weeks), will allow us to understand the effects of physical activity-induced weight loss on this cross-talk in obese adolescents.

Data will be analyzed using Stata (StataCorp, College Station, USA) and IBM Statistics SPSS version 22 (IBM Corp, 2013, Chicago, IL, USA) and significance will be accepted at a two-sided alpha level of p<0.05. After testing for normal distribution (Shapiro-Wilk test), data will be treated either by parametric or non-parametric analyses according to statistical assumptions.

Student t tests or Mann-Whitney U test will be performed to compare adipose tissue (total, subcutaneous, visceral) variation reported to bone mass variation at lumbar spine between groups at baseline. Pearson (or Spearman when appropriate) correlation coefficient will be used and compared with Fisher test (command corcor Stata) to measure the link between exercise-inducing weight loss on adipose tissue and bone mass variations. Longitudinal data will be treated using a mixed model analyses in order to treat fixed effects group, time and group x time interaction taking into account between and within participant variability.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63003
    • Recruiting
    • CHU Clermont-Ferrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• All adolescent girls will have to be free of any recent history of hospitalization (past two years) or of systemic illness lasting more than two weeks in the past 12 months. .

Exclusion Criteria:

• pregnant girl
• diabetes
• insulin-resistance
• hypo or hyper-thyroid
• consuming alcohol
• smokers

Study Plan

How is the study designed?

Design Details

• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intervention group; an intervention group who will undergo the management program combining physical activity and restrictive diet at Tza Nou Medical House for 10 months	Radiation: weight loss
Other: a control group; a control group who will not undergo any intervention	Radiation: weight loss

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
change from baseline fat mass measured by Dual energy X-ray Absorptiometry (DXA)	at 10 months.
change from baseline bone mass measured by Dual energy X-ray Absorptiometry (DXA)	at 10 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Whole body measured by Dual energy X-ray Absorptiometry (DXA)	at 10 months
weight waist	at 10 months.
waist circumference	at 10 months.
lower limb bone lengths	at 10 months.
Physical activity measured with International Physical Activity Questionnaire	at 10 months.
Tanner's stages model for pubertal maturation	at 10 months.
Energy metabolism assessed by cycle-ergometer submaximal aerobic fitness	at 10 months.
bone mineral density measured by Peripheral Quantitative Computed Tomography	at 10 months.
bone mineral status measured by Quantitative Ultra-Sound (QUS) on the non-dominant calcaneus.	at 10 months.
Endocrine assays	at 10 months.
Adolescents' observance to the weight loss lifestyle program	at 10 months
Metabolomics analysis in blood plasma	at 10 months
Ex-vivo mechanistic analysis	at 10 months
left ventricular end diastolic diameter measured by echocardiography	at 10 months
left ventricular end systolic diameter measured by echocardiography	at 10 months
posterior wall thickness measured by echocardiography	at 10 months
interventricular septum thickness measured by echocardiography	at 10 months
left ventricular mass indexed measured by echocardiography	at 10 months
left ventricular ejection fraction measured by echocardiography	at 10 months
valves velocity measured by echocardiography	at 10 months
isovolumic relaxation time measured by echocardiography	at 10 months
strain rate measured by echocardiography	at 10 months
myocardial dyssynchrony measured by echocardiography	at 10 months
carotid-intima-media thickness measured by echography	at 10 months

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Collaborators: Australian Catholic University; Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques; Tza Nou Medical House for children and adolescents, 230, rue Vercingétorix - B.P. 77

Publications and helpful links

General Publications

• Chaplais E, Dutheil F, Naughton G, Greene D, Pereira B, Thivel D, Courteix D. Cross-sectional and longitudinal study protocols of the 'ADIposity and BOne metabolism: effects of eXercise-induced weight loss in obese adolescents' (ADIBOX) project. BMJ Open. 2016 Oct 18;6(10):e011407. doi: 10.1136/bmjopen-2016-011407.

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Anticipated): October 1, 2016
• Study Completion (Anticipated): October 1, 2016

Study Registration Dates

• First Submitted: November 3, 2015
• First Submitted That Met QC Criteria: December 7, 2015
• First Posted (Estimate): December 10, 2015

Study Record Updates

• Last Update Posted (Estimate): July 29, 2016
• Last Update Submitted That Met QC Criteria: July 28, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: physical activity; obesity; adolescents; weight loss; bone; fat; adipocytes; osteocytes
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss
• Other Study ID Numbers: CHU-0249; 2015-A01024-45 (Registry Identifier: 2015-A01024-45)