Overweight and Obesity and Puberty Development Cohort Study

Overweight and Obesity Clinical Trial

Official title:

The Effect of Childhood Overweight and Obesity and Genetic Factors on Puberty Development: a Prospective Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04113070
• Other study ID #: SCMCIRB-K2019007
• Status: Recruiting
• Start date: October 11, 2019
• Est. completion date: December 30, 2026

Study information

• Verified date: February 2020
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: Shijian Liu, Ph.D
• Phone: 21-38625637
• Email: liushijian[@]scmc.com.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Precocious puberty and childhood overweight and obesity are important public health problems that both had adverse effects, which including psychological symptom in childhood, short final height or reproductive dysfunction in adulthood, on children's physical and psychological development.The prevalence of precocious puberty and childhood overweight and obesity are both high, and a growing body of epidemiological studies suggested that there was a close relationship of childhood overweight and obesity with puberty development, especially in girls. However, the underlying mechanism between them is unclear. Existing evidence shows that the occurrence of precocious puberty and overweight and obesity are the result of interaction of multiple factors, which consists growth environment and genetics, and many previous studies provided that more overlapping genes existed between obesity and precocious puberty patients, suggesting that common genes may result in these diseases. Therefore, based on a case control study, which will investigate the associations between obesity pleiotropic genes and early puberty, the researchers will collect information related to obesity, growth environment factors and risk genes in this study to evaluate the relationships of these related factors and precocious puberty, and to further explore whether there exists biological interaction effects of these risk factors on sexual precocity. This project has been approved by the Ethics Committee of Shanghai Children's Medical Center.

Description:

1. Purpose: A prospective cohort study. The aim of this study is to investigate the effect of pediatric weight status and childhood growth environment on puberty development.

2. Participants: Participants are primary school children aged 6- to 12-year-old, and their parents must be willing to engage in this study and comply with study requirements.

3. Study Procedure: According to geographic and population distribution, about 40 schools included in this study by stratified, random clustering sampling in three cities of China, including Qufu, Zhongshan and Huhhot. Participant will accept anthropometric measuring by clinicians from the three collaborated hospitals, including BoAi Hospital of Zhongshan, QuFu People' s Hospital and Inner Mongolia People's Hospital. This study will be conducted among children of grade 1 to 3 from selected schools in 2019 and the first, secondary and third follow-up will be conducted one, two and three year later respectively.

4. Exposures: Participants with overweight or obesity will be included in overweight and obesity group at baseline.

5. Related risk factors: Childhood growth and family environmental information, including physical activity, diet habit, sleep duration, family structure and family social-economic status, will be collected by parent-reported questionnaire;

6. Outcomes measures: Participants' puberty stage will be evaluated by secondary sexual characteristics development by physician palpation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 14100
• Est. completion date: December 30, 2026
• Est. primary completion date: October 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

Inclusion Criteria:

• Children over 6 years old from grade 1, 2 and 3 in selected primary schools in Zhongshan, Qufu and Huhhot since 2019

Exclusion Criteria:

• Children with overweight or obesity had a history of hormone drug treatment last for 6 months

Related Conditions & MeSH terms

• Obesity
• Overweight
• Overweight and Obesity
• Precocious Puberty
• Puberty, Precocious

Intervention

Device:
• Anthropometric measuring
To divide participants into overweight and obesity and non-overweight group according to their weight status, height (H), weight (W) and waist circumference (WC) will be measured with a uniform tool, which has been calibrated. When measuring the height, the subjects are required to take off their shoes and stand in an upright position. To measuring weight, the subjects are required to wear close-fitting clothes and bare feet. Subjects are required to take the standing position to measure waist circumference horizontally at the mid-point of line between the lower margin of the ribs and the upper margin of the ilium. All those data will be kept one decimal place. Anthropometric measuring will be taken at baseline and follow-up periods.

Other:
• Growth environment evaluation
The information of children' growth environment, including family environment, physical activities, dietary and sleep habits, will be collected by parent-report questionnaire at baseline and follow-up periods.

Locations

Country	Name	City	State
China	Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai

Sponsors (5)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine	BoAi Hospital of Zhongshan, Inner Mongolia People's Hospital, QuFu People's Hospital, Shanghai Children's Medical Center

Country where clinical trial is conducted

China, 

References & Publications (20)

Abdel Ghany SM, Sayed AA, El-Deek SEM, ElBadre HM, Dahpy MA, Saleh MA, Sharaf El-Deen H, Mustafa MH. Obesity risk prediction among women of Upper Egypt: The impact of serum vaspin and vaspin rs2236242 gene polymorphism. Gene. 2017 Aug 30;626:140-148. doi: 10.1016/j.gene.2017.05.007. Epub 2017 May 4. — View Citation

Biro FM, Khoury P, Morrison JA. Influence of obesity on timing of puberty. Int J Androl. 2006 Feb;29(1):272-7; discussion 286-90. Epub 2005 Dec 20. Review. — View Citation

Boyne MS, Thame M, Osmond C, Fraser RA, Gabay L, Reid M, Forrester TE. Growth, body composition, and the onset of puberty: longitudinal observations in Afro-Caribbean children. J Clin Endocrinol Metab. 2010 Jul;95(7):3194-200. doi: 10.1210/jc.2010-0080. Epub 2010 Apr 28. — View Citation

Bridges NA, Christopher JA, Hindmarsh PC, Brook CG. Sexual precocity: sex incidence and aetiology. Arch Dis Child. 1994 Feb;70(2):116-8. — View Citation

Chen C, Zhang Y, Sun W, Chen Y, Jiang Y, Song Y, Lin Q, Zhu L, Zhu Q, Wang X, Liu S, Jiang F. Investigating the relationship between precocious puberty and obesity: a cross-sectional study in Shanghai, China. BMJ Open. 2017 Apr 11;7(4):e014004. doi: 10.1136/bmjopen-2016-014004. Erratum in: BMJ Open. 2017 Aug 23;7(8):e014004corr1. — View Citation

Colmenares A, Gunczler P, Lanes R. Higher prevalence of obesity and overweight without an adverse metabolic profile in girls with central precocious puberty compared to girls with early puberty, regardless of GnRH analogue treatment. Int J Pediatr Endocrinol. 2014;2014(1):5. doi: 10.1186/1687-9856-2014-5. Epub 2014 Apr 17. — View Citation

Deng F, Tao FB, Liu DY, Xu YY, Hao JH, Sun Y, Su PY. Effects of growth environments and two environmental endocrine disruptors on children with idiopathic precocious puberty. Eur J Endocrinol. 2012 May;166(5):803-9. doi: 10.1530/EJE-11-0876. Epub 2012 Feb 8. — View Citation

Euling SY, Selevan SG, Pescovitz OH, Skakkebaek NE. Role of environmental factors in the timing of puberty. Pediatrics. 2008 Feb;121 Suppl 3:S167-71. doi: 10.1542/peds.2007-1813C. — View Citation

Grarup N, Moltke I, Andersen MK, Dalby M, Vitting-Seerup K, Kern T, Mahendran Y, Jørsboe E, Larsen CVL, Dahl-Petersen IK, Gilly A, Suveges D, Dedoussis G, Zeggini E, Pedersen O, Andersson R, Bjerregaard P, Jørgensen ME, Albrechtsen A, Hansen T. Loss-of-function variants in ADCY3 increase risk of obesity and type 2 diabetes. Nat Genet. 2018 Feb;50(2):172-174. doi: 10.1038/s41588-017-0022-7. Epub 2018 Jan 8. — View Citation

Kaplowitz PB. Link between body fat and the timing of puberty. Pediatrics. 2008 Feb;121 Suppl 3:S208-17. doi: 10.1542/peds.2007-1813F. Review. — View Citation

Klein KO. Precocious puberty: who has it? Who should be treated? J Clin Endocrinol Metab. 1999 Feb;84(2):411-4. Review. — View Citation

Lebrethon MC, Bourguignon JP. Management of central isosexual precocity: diagnosis, treatment, outcome. Curr Opin Pediatr. 2000 Aug;12(4):394-9. Review. — View Citation

Luke B. Adverse effects of female obesity and interaction with race on reproductive potential. Fertil Steril. 2017 Apr;107(4):868-877. doi: 10.1016/j.fertnstert.2017.02.114. Review. — View Citation

Marshall WA, Tanner JM. Variations in pattern of pubertal changes in girls. Arch Dis Child. 1969 Jun;44(235):291-303. — View Citation

Marshall WA, Tanner JM. Variations in the pattern of pubertal changes in boys. Arch Dis Child. 1970 Feb;45(239):13-23. — View Citation

Ong KK, Bann D, Wills AK, Ward K, Adams JE, Hardy R, Kuh D; National Survey of Health and Development Scientific and Data Collection Team. Timing of voice breaking in males associated with growth and weight gain across the life course. J Clin Endocrinol Metab. 2012 Aug;97(8):2844-52. Epub 2012 May 31. — View Citation

Sun Y, Tao F, Su PY; China Puberty Research Collaboration. National estimates of pubertal milestones among urban and rural Chinese boys. Ann Hum Biol. 2012 Nov-Dec;39(6):461-7. doi: 10.3109/03014460.2012.712156. Epub 2012 Aug 6. — View Citation

Sun Y, Tao FB, Su PY, Mai JC, Shi HJ, Han YT, Wang H, Lou XM, Han J, Liu J. National estimates of the pubertal milestones among urban and rural Chinese girls. J Adolesc Health. 2012 Sep;51(3):279-84. doi: 10.1016/j.jadohealth.2011.12.019. Epub 2012 Mar 15. — View Citation

Wang M, Zhang Y, Lan D, Hill JW. The Efficacy of GnRHa Alone or in Combination with rhGH for the Treatment of Chinese Children with Central Precocious Puberty. Sci Rep. 2016 Apr 13;6:24259. doi: 10.1038/srep24259. — View Citation

Wasim M, Awan FR, Najam SS, Khan AR, Khan HN. Role of Leptin Deficiency, Inefficiency, and Leptin Receptors in Obesity. Biochem Genet. 2016 Oct;54(5):565-72. doi: 10.1007/s10528-016-9751-z. Epub 2016 Jun 16. Review. — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of precocious puberty	All subjects will accept physician palpation to assess their puberty development stage according to Tanner staging method: Testicular volume will be measure by palpation and a Prader testicular meter and be graded to 1 (< 4 ml) to 5 (> 20 ml) in boys. Breast development will be graded to 1(pre-adolescent) to 5 (fully mature) in girls. Pubic hair development will be graded to 1(pre-adolescent) to 5 (fully mature) in both boys and girls. Precocious puberty will be defined as the onset age of breast development (B2) or pubic hair development (PH2) before 8 years or menarche before 10 years in girls and of PH2 or testicular enlargement (T2) before 9 years in boys. For girls with overweight or obesity, breast ultrasound will be used to discriminate glandular breast and fat tissue.	1 year
Secondary	Rate of early puberty	All subjects will accept physician palpation to assess their puberty development stage according to Tanner staging method: Testicular volume will be measure by palpation and a Prader testicular meter and be graded to 1 (< 4 ml) to 5 (> 20 ml) in boys. Breast development will be graded to 1(pre-adolescent) to 5 (fully mature) in girls. Pubic hair development will be graded to 1(pre-adolescent) to 5 (fully mature) in both boys and girls. Early puberty will be defined as children reached a certain puberty stage earlier than the median age of that stage. According to a large Chinese population-based study, the median ages for pubertal stages will be referenced. Moreover, the presence of menarche before 12 years in girls and of voice breaking before 13 years in boys will also be categorized as early puberty.	1 year