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临床试验/NCT03490448
NCT03490448已完成不适用

The Changes of Body Composition, Glucolipid Metabolism and Bone Metabolism in Obese Children and Adolescents After Weight Loss Camp

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine1 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2014年7月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
53
试验地点
1
主要终点
changes of serum 25-OHD after weight loss

研究概览

简要总结

Vitamin D plays a significant role in calcium and phosphorus homeostasis for maintaining structural integrity and function of musculoskeletal system. Furthermore, recent studies have revealed that vitamin D can decrease the risk of many conditions other than skeletal disease, including autoimmune diseases, cancers, obesity and obesity-related diseases, such as type 2 diabetes and cardiovascular disease. Vitamin D may influence calcium absorption to affect obesity indirectly, regulate adipocyte differentiation and relieve the development of metabolic syndrome by mediating levels of inflammatory factors.

Another indicator of bone metabolism-osteocalcin may also be involved in energy metabolism and glucose metabolism, and undercarboxylated osteocalcin (ucOC) is the form which has physiological activity. ucOC may recombine with the receptors on the surface of pancreas β cells, adipocytes, hepatocytes and intestinal endocrine cell to regulate insulin secretion and insulin sensitivity.

Currently, the prevalence of vitamin D deficiency is a global problem in all age groups currently, even in countries with sun exposure all year around. The obesity group tend to have a higher incidence of vitamin D deficiency.Moreover, the obesity group tend to have a higher incidence of vitamin D deficiency and a lower level of serum osteocalcin.

This study observed the changes of body composition and glucolipid metabolism and bone metabolism during weight loss, and investigated the correlations among them.

详细描述

Obese children have a higher incidence of vitamin D deficiency (VDD), which resulted from unhealthy life style such as less time outdoors, more sedentary time, imbalance of dietary intake. Adipose tissue is the storage position of vitamin D, and the storage formation include 25-OHD2 and 25-OHD3. Theoretically, the reserves of vitamin D in adipose tissue of obese children might release to the circulation after weight loss. For further, it is necessary to clarify the relationship between the improvement of metabolic risk with vitamin D status after weight loss.

Osteocalcin is produced and secreted by osteoblast specifically. Recent studies have shown that it regulated glucose metabolism and energy metabolism. Obese group may have a lower level of serum osteocalcin. Both 25-OHD and osteocalcin have association with energy metabolism. This study will provide evidence to realize the relationship between bone metabolism and obesity.

In our study, all subjects were recruited from the obese children and adolescents aged 9~17 years who participated in six-week weight loss camp in July ~ August, 2014. Body mass index (BMI) was calculated as weight (kg) divided by height squared (m2). Obesity was defined as having a BMI greater than or equal to the 95th percentile for age and sex according to WHO standard. Exclusion criteria included: 1) obesity caused by endocrine or heredity diseases (eg, hypothyroidism, Prader-Willi syndrome, single-gene defects); 2) any disease influencing vitamin D metabolism (eg, such as metabolic bone diseases, rickets, nephritic syndrome and hepatic failure); 3) any supplementation use or any medication affecting vitamin D metabolism use.

All subjects underwent a closed-off weight loss program for six weeks. The intervention methods included aerobic exercise and appropriate caloric control. The dietary was designed on the basis of ensuring the daily energy physiological requirement, and basal metabolic rate (BMR) was calculated to formulate diet project according to Harris-Benedict formula. The diet was composed of 20% protein, 30% fat and 50% carbohydrates. During the camp, all subjects had never taken any kinds of nutritional supplements.

Before intervention, all subjects received exercise load test to ensure safe and effective physical exercise. In the exercise, heart rate was monitored to ensure the small-medial load aerobic exercise. The exercise programs included ball games, such as badminton, table tennis, and basketball, and also included jogging, brisk walking, swimming and cycle ergometer. All kinds of sports were conducted indoor, twice per day, 6 days per week, and lasted for 2 hours every time. The weight loss camp was staffed by professional sports coaches and medical workers. Exercise intensity was estimated by a formula: exercise intensity (target heart rate) =resting heart rate + heart rate reserve (maximum heart rate-resting heart rate) × (20%~40%).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
9 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Obesity was defined as having a body mass index (BMI) greater than or equal to the 95th percentile for age and sex according to WHO standard. BMI was calculated as weight (kg) divided by height squared (m2).

排除标准

  • obesity caused by endocrine or heredity diseases (eg, hypothyroidism, Prader-Willi syndrome, single-gene defects);
  • any disease influencing vitamin D metabolism (eg, such as metabolic bone diseases, rickets, nephritic syndrome and hepatic failure);
  • any supplementation use or any medication affecting vitamin D metabolism use.

研究组 & 干预措施

intervention group

Other

aerobic exercise and appropriate caloric control

干预措施: aerobic exercise and appropriate caloric control (Behavioral)

结局指标

主要结局

changes of serum 25-OHD after weight loss

时间窗: after six-week weight loss camp

次要结局

  • changes of body composition after weight loss(after six-week weight loss camp)
  • changes of glucolipid metabolism after weight loss(after six-week weight loss camp)
  • changes of serum osteocalcin after weight loss(after six-week weight loss camp)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

qingya tang

chief physician

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

研究点 (1)

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