Metabolic Syndrome among Adolescents: A study of early detection with a Comprehensive Intervention to achieve improvement in Clinical, Biophysical, Anthropometric, and Metabolic markers
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- This data will contribute to making health-related policies for adolescents and protocols for screening for early diagnosis and treatment of MetS. •A comprehensive health care model will encompass various levels of health care, which is necessary to achieve better management of MetS. •This comprehensive intervention in adolescents with MetS may help develop appropriate modules for extending it to the larger population.
研究概览
简要总结
Metabolic syndrome (MetS) is linked with multiple disease states, and prevalence among adolescents is rising in tandem with obesity rates with increased risk of developing type 2 diabetes and cardiovascular disease in adulthood. Early detection and appropriate intervention are helpful in halting disease progression. These risk factors can be modifiable by appropriate lifestyle intervention and treatment. Globally, relatively very less interventional data is available. In India, interventional findings are scarce in adolescents with an early diagnosis of MetS. This study will explore the effect of early detection and comprehensive intervention on the clinical, anthropometric, metabolic, and inflammatory status of adolescents with MetS.
Objectives-To assess the effect of early detection, and comprehensive intervention on Clinical, biophysical, and anthropometric parameters, and Metabolic, inflammatory, and adiposity markers in adolescents with metabolic syndrome.
Methods- This will be an interventional study on adolescents (10-19Yrs). Obese and overweight adolescents will be screened from Public and Private Secondary schools and Junior colleges. Eligible and willing participants will be enrolled for the detection of MetS and comprehensive intervention for 1year. Their baseline, intermediate (6 months), and post-intervention assessment of clinical, biophysical, and anthropometric parameters will be done. Baseline and post-intervention metabolic, inflammatory, and adiposity markers will be analyzed and compared to assess the effect of the intervention.
Outcome- Improvement in clinical signs, significant change in behavioral and psychological aspects as well as metabolic, inflammatory, and adiposity status. With the above findings, a comprehensive intervention model will be helpful for treating and managing Mets in adolescence.
**Hypothesis-**Can early identification and comprehensive intervention in adolescents with metabolic syndrome help to improve clinical, biophysical, anthropometric, metabolic, inflammatory, and adiposity markers?
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 10.00 Year(s) 至 19.00 Year(s)（—）
- 性别
- All
入选标准
- •Adolescents 10 to 19 years of age.
- •Healthy and apparently asymptomatic adolescents diagnosed with metabolic syndrome and willing to participate.
排除标准
- •Adolescents having a chronic illness or any co-morbidity like congenital heart disease, renal failure, hemophilia, thalassemia, Type I Diabetes, etc.
- •Adolescents who are receiving treatment such as steroids for any reason, thyroid hormones, antiepileptics, or any other medication.
- •Adolescents with secondary causes of obesity (Endocrine, Syndromic ) and hypertension ( Renal, Adrenal, etc ).
结局指标
主要结局
This data will contribute to making health-related policies for adolescents and protocols for screening for early diagnosis and treatment of MetS. •A comprehensive health care model will encompass various levels of health care, which is necessary to achieve better management of MetS. •This comprehensive intervention in adolescents with MetS may help develop appropriate modules for extending it to the larger population.
时间窗: Screening, baseline, and post-intervention visit
次要结局
- A comprehensive health care model will encompass various levels of health care which is necessary to achieve better management of Metabolic Syndrome(Baseline visit, Comprehensive Intervention and Post-intervention visit)
研究者
Dr Shailaja Vijaykumar Mane
Department of Pediatrics, Dr D Y Patil Medical College Hospital and Research Centre Pune