Overweight and Obesity and Puberty Development Cohort Study

NCT04113070 | Recruiting DMC

• 1 other identifier: SCMCIRB-K2019007
• Study Type: observational
• Target: 14,100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Precocious Puberty; Overweight and Obesity

Keywords

Child health care; Weight status; Environment; puberty

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Rate of early puberty

  1 year

Study Arms (2)

Overweight and obesity group

1. Children with BMI cutoff points greater than 25.0 or 30.0 at 18 years old were defined overweight or obesity according to age- and sex-specific cutoff points standard proposed by International Obesity Task Force (IOTF) for 2- to 18-year-old children. 2. Willingness to comply with study requirements

Device: Anthropometric measuring; Other: Growth environment evaluation

Non-overweight group

1. Children with BMI smaller than 25.0 at 18 years old were defined non-overweight according to age- and sex-specific cutoff points standard proposed by International Obesity Task Force (IOTF) for 2- to 18-year-old children. 2. Willingness to comply with study requirements

Device: Anthropometric measuring; Other: Growth environment evaluation

Interventions

Anthropometric measuring DEVICE

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.

Non-overweight group; Overweight and obesity group

Growth environment evaluation OTHER

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.

Non-overweight group; Overweight and obesity group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

A stratified random sample of children over 6 years old from grade 1 to 3 of selected primary schools in three cities in China

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead
• Shanghai Children's Medical Center: collaborator
• BoAi Hospital of Zhongshan: collaborator
• QuFu People's Hospital: collaborator
• Inner Mongolia People's Hospital: collaborator

Study Sites (1)

Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

Related Publications (21)

• 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.

  PMID: 28400459 BACKGROUND

• 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.

  PMID: 24742263 BACKGROUND

• 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.

  PMID: 27072597 BACKGROUND

• 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.

  PMID: 28366413 BACKGROUND

• 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.

  PMID: 22318748 BACKGROUND

• 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.

  PMID: 20427487 BACKGROUND

• 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. doi: 10.1111/j.1365-2605.2005.00602.x. Epub 2005 Dec 20.

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• 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.

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• 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.

  PMID: 28479386 BACKGROUND

• Grarup N, Moltke I, Andersen MK, Dalby M, Vitting-Seerup K, Kern T, Mahendran Y, Jorsboe E, Larsen CVL, Dahl-Petersen IK, Gilly A, Suveges D, Dedoussis G, Zeggini E, Pedersen O, Andersson R, Bjerregaard P, Jorgensen 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.

  PMID: 29311636 BACKGROUND

• 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.

  PMID: 27313173 BACKGROUND

• 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.

  PMID: 18245510 BACKGROUND

• Marshall WA, Tanner JM. Variations in pattern of pubertal changes in girls. Arch Dis Child. 1969 Jun;44(235):291-303. doi: 10.1136/adc.44.235.291. No abstract available.

  PMID: 5785179 BACKGROUND

• Marshall WA, Tanner JM. Variations in the pattern of pubertal changes in boys. Arch Dis Child. 1970 Feb;45(239):13-23. doi: 10.1136/adc.45.239.13.

  PMID: 5440182 BACKGROUND

• Bridges NA, Christopher JA, Hindmarsh PC, Brook CG. Sexual precocity: sex incidence and aetiology. Arch Dis Child. 1994 Feb;70(2):116-8. doi: 10.1136/adc.70.2.116.

  PMID: 8129431 BACKGROUND

• Lebrethon MC, Bourguignon JP. Management of central isosexual precocity: diagnosis, treatment, outcome. Curr Opin Pediatr. 2000 Aug;12(4):394-9. doi: 10.1097/00008480-200008000-00020.

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• Klein KO. Precocious puberty: who has it? Who should be treated? J Clin Endocrinol Metab. 1999 Feb;84(2):411-4. doi: 10.1210/jcem.84.2.5533. No abstract available.

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• 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.

  PMID: 22921139 BACKGROUND

• 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.

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• 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. doi: 10.1210/jc.2011-3445. Epub 2012 May 31.

  PMID: 22654120 BACKGROUND

• Yu T, Yu Y, Li X, Xue P, Yu X, Chen Y, Kong H, Lin C, Wang X, Mei H, Wang D, Liu S. Effects of childhood obesity and related genetic factors on precocious puberty: protocol for a multi-center prospective cohort study. BMC Pediatr. 2022 May 27;22(1):310. doi: 10.1186/s12887-022-03350-x.

  PMID: 35624438 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

1. Blood sample: Part of overweight and obesity and normal weight participants are required to provided venous blood sample to test their hormone level from serum fraction and analysis risk genes from plasma fraction at baseline and 1st follow-up period. 2. Urine sample: Part of overweight and obesity and normal weight participants are required to provided urine sample to test environment endocrine disruptors exposed level at baseline and 1st follow-up period. 3. Stool sample: Part of overweight and obesity and normal weight participants are required to provided stool sample to test their enteric microorganism at baseline and 1st follow-up period.

MeSH Terms

Conditions

Puberty, Precocious; Overweight; Obesity

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Shijian Liu, Ph.D

  Shanghai Children's Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shijian Liu, Ph.D

CONTACT

21-38625637; liushijian@scmc.com.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: staff of Research Department

Study Record Dates

• First Submitted: September 20, 2019
• First Posted: October 2, 2019
• Study Start: October 11, 2019
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: February 5, 2020

Record last verified: 2020-02

Locations

CN (1)