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

Obesity Clinical Trial

— ADIBOX  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02626273
• Other study ID #: CHU-0249
• Secondary ID: 2015-A01024-45
• Status: Recruiting
• Phase: N/A
• First received: November 3, 2015
• Last updated: July 28, 2016
• Start date: September 2015
• Est. completion date: October 2016

Study information

• Verified date: July 2016
• Source: University Hospital, Clermont-Ferrand
• Contact: Patrick LACARIN
• Phone: 04 73 75 11 95
• Email: placarin[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 16 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

Radiation:
• weight loss

Locations

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

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	AME2P Laboratory (EA 3533), Laboratory of Metabolic Adaptations to Exercise in Physiological and Pathological conditions – University Clermont Auvergne, Australian Catholic University, Tza Nou Medical House for children and adolescents, 230, rue Vercingétorix - B.P. 77

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change from baseline fat mass measured by Dual energy X-ray Absorptiometry (DXA)		at 10 months.	No
Primary	change from baseline bone mass measured by Dual energy X-ray Absorptiometry (DXA)		at 10 months	No
Secondary	Whole body measured by Dual energy X-ray Absorptiometry (DXA)		at 10 months	No
Secondary	weight waist		at 10 months.	No
Secondary	waist circumference		at 10 months.	No
Secondary	lower limb bone lengths		at 10 months.	No
Secondary	Physical activity measured with International Physical Activity Questionnaire		at 10 months.	No
Secondary	Tanner's stages model for pubertal maturation		at 10 months.	No
Secondary	Energy metabolism assessed by cycle-ergometer submaximal aerobic fitness		at 10 months.	No
Secondary	bone mineral density measured by Peripheral Quantitative Computed Tomography		at 10 months.	No
Secondary	bone mineral status measured by Quantitative Ultra-Sound (QUS) on the non-dominant calcaneus.		at 10 months.	No
Secondary	Endocrine assays		at 10 months.	No
Secondary	Adolescents' observance to the weight loss lifestyle program		at 10 months	No
Secondary	Metabolomics analysis in blood plasma		at 10 months	No
Secondary	Ex-vivo mechanistic analysis		at 10 months	No
Secondary	left ventricular end diastolic diameter measured by echocardiography		at 10 months	No
Secondary	left ventricular end systolic diameter measured by echocardiography		at 10 months	No
Secondary	posterior wall thickness measured by echocardiography		at 10 months	No
Secondary	interventricular septum thickness measured by echocardiography		at 10 months	No
Secondary	left ventricular mass indexed measured by echocardiography		at 10 months	No
Secondary	left ventricular ejection fraction measured by echocardiography		at 10 months	No
Secondary	valves velocity measured by echocardiography		at 10 months	No
Secondary	isovolumic relaxation time measured by echocardiography		at 10 months	No
Secondary	strain rate measured by echocardiography		at 10 months	No
Secondary	myocardial dyssynchrony measured by echocardiography		at 10 months	No
Secondary	carotid-intima-media thickness measured by echography		at 10 months	No