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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03490448
Recruitment Status : Completed
First Posted : April 6, 2018
Last Update Posted : April 6, 2018
Sponsor:
Information provided by (Responsible Party):
qingya tang, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Obesity, Childhood Vitamin D Deficiency Behavioral: aerobic exercise and appropriate caloric control Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: The Changes of Body Composition, Glucolipid Metabolism and Bone Metabolism in Obese Children and Adolescents After Weight Loss Camp
Actual Study Start Date : July 6, 2014
Actual Primary Completion Date : August 16, 2014
Actual Study Completion Date : August 16, 2014

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Arm Intervention/treatment
intervention group
aerobic exercise and appropriate caloric control
Behavioral: 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.In the exercise, heart rate was monitored to ensure the small-medial load aerobic exercise. All kinds of sports were conducted indoor, twice per day, 6 days per week, and lasted for 2 hours every time.




Primary Outcome Measures :
  1. changes of serum 25-OHD after weight loss [ Time Frame: after six-week weight loss camp ]

Secondary Outcome Measures :
  1. changes of serum osteocalcin after weight loss [ Time Frame: after six-week weight loss camp ]
  2. changes of body composition after weight loss [ Time Frame: after six-week weight loss camp ]
    Indicators of body composition included weight, body mass index, triceps skinfold thickness and subcutaneous skinfold thickness.

  3. changes of glucolipid metabolism after weight loss [ Time Frame: after six-week weight loss camp ]
    Indicators of glucose metabolism included fasting blood glucose (FBG) and fasting insulin (FINS). Indicators of lipid metabolism included Total cholesterol (TC), triglyceride (TG), high density lipoprotein (HDL) and low density lipoprotein (LDL).


Other Outcome Measures:
  1. changes of other bone metabolism indicators after weight loss [ Time Frame: after six-week weight loss camp ]
    Other bone metabolism indicators included parathyroid hormone (PTH), bone specific alkaline phosphatase (BALP), total propeptide of type I procollagen (T-PINP) and β-isomerized form carboxy-terminal telopeptide of type I collagen (β-CTX).



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Ages Eligible for Study:   9 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03490448


Locations
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China, Shanghai
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai, China, 200092
Sponsors and Collaborators
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Investigators
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Principal Investigator: Qingya Tang, Mater Department of Clinical Nutrition, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Publications of Results:

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Responsible Party: qingya tang, chief physician, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT03490448    
Other Study ID Numbers: XH-DCN-Obesity
First Posted: April 6, 2018    Key Record Dates
Last Update Posted: April 6, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by qingya tang, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine:
vitamin D
obesity
body composition
glucose metabolism
lipid metabolism
Additional relevant MeSH terms:
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Vitamin D Deficiency
Pediatric Obesity
Weight Loss
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Body Weight Changes
Avitaminosis
Deficiency Diseases
Malnutrition