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临床试验/CTRI/2024/06/069244
CTRI/2024/06/069244尚未招募不适用

Effect of home based exercise regimen in improving body composition and cardiometabolic parameters in young adults with normal weight obesity

MAHE Post graduate research grant1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2024年7月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
68
试验地点
1
主要终点
1.BMI

研究概览

简要总结

Studies have found that there is an increasing prevalence of obesity globally .There is also a similar growing prevalence of obesity in the Indian population . Studies have predicted that the prevalence of overweight will more than double among Indian adults aged 20–69 years between 2010 and 2040, while the prevalence of obesity will triple. And also as a result of which, there will be an increase in the prevalence of lifestyle related disorders such as cardiovascular disease and diabetes mellitus affecting not only an increased portion of the population but also a younger demographic. Obesity, which is defined based mainly on the Body mass index ( above range of >25 kg/m2 in the Indian population), has been associated with an increasing association with cardiovascular disease, insulin resistance and type II diabetes mellitus. Recent studies have also found that there is a strong association of abdominal adiposity and the complications associated with obesity such as diabetes mellitus, cardiovascular disease. However, BMI as a tool does not differentiate between lean body mass and body fat percentage. As a result of which, a portion of the population who have a higher body fat percentage and a higher percentage of visceral fat (therefore associated with greater risks of morbidity and mortality) will not be screened and treated. Normal weight obesity is defined as individuals with normal BMI (that is 18.9kg/m2 to 22.9kg/m2 and overweight under 23.0km/m2 to 24.9 kg/m2) that have an increased body fat percentage. There is a lack of literature on the incidence of normal weight obesity in the Indian population, who, due to their carbohydrate rich diet and increasingly sedentary lifestyle, are more prone to normal weight obesity. There is also a lack of literature on the effects of exercise on the body composition of normal weight obesity individuals. Especially in the young adult population who are more prone to pick up the lifestyle habits. An increased involvement of physical exercise in the lifestyle of these individuals might be associated with reducing the incidence of non communicable diseases such as cardiovascular diseases and diabetes mellitus. The use of body fat percentage would also help identify the hidden part of the iceberg, consisting of cases who have a higher risk of suffering from non-communicable diseases that go undetected with an ineffective screening test like BMI.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 30.00 Year(s)(—)
性别
Male

入选标准

  • Male participants will be taken from the student population of MAHE institution.
  • Participants will be from the ages of 18 to 30 years.
  • Participants with body fat percentage above 23.1%9 and with a BMI within the normal range– that is, above 18.5 kg/m2 to 24.9 kg/m2 (thus including both groups under normal weight and overweight categories).
  • 4.Participants who have MET less than 4.0 will be included in the study after the participants answer the GPAQ questionnaire.

排除标准

  • Participants having a history of cardiovascular disease and renal disease will be excluded from the study (as it interferes with the body composition assessment).
  • Participants will be excluded from the study if they are unable to perform the exercise regimen, due to musculoskeletal injury, cardiovascular disease history, etc,.
  • Participants having type I diabetes mellitus will be excluded from the study.

结局指标

主要结局

1.BMI

时间窗: Investigations will be performed at 0 weeks before start of the trial and repeated after 12 week combined exercise regimen

2.Fat free mass

时间窗: Investigations will be performed at 0 weeks before start of the trial and repeated after 12 week combined exercise regimen

3.FFMI (index)

时间窗: Investigations will be performed at 0 weeks before start of the trial and repeated after 12 week combined exercise regimen

4.Body fat percentage

时间窗: Investigations will be performed at 0 weeks before start of the trial and repeated after 12 week combined exercise regimen

5.Body fat mass index(BFMI)

时间窗: Investigations will be performed at 0 weeks before start of the trial and repeated after 12 week combined exercise regimen

6.Waist/hip ratio

时间窗: Investigations will be performed at 0 weeks before start of the trial and repeated after 12 week combined exercise regimen

7.LDL, HLD, Serum triglycerides, total cholesterol

时间窗: Investigations will be performed at 0 weeks before start of the trial and repeated after 12 week combined exercise regimen

8. Fasting blood glucose, Fasting insulin, Insulin sensitivity (HOMA-IR)

时间窗: Investigations will be performed at 0 weeks before start of the trial and repeated after 12 week combined exercise regimen

9.Anthropometric measures such as waist circumference, hip circumference, waist to hip ratio and skin fold thickness at pectoral, abdomen and thigh

时间窗: Investigations will be performed at 0 weeks before start of the trial and repeated after 12 week combined exercise regimen

10. Blood pressure

时间窗: Investigations will be performed at 0 weeks before start of the trial and repeated after 12 week combined exercise regimen

次要结局

  • 1.Waist/hip ratio(2.LDL, HLD, Serum triglycerides, total cholesterol)

研究者

发起方
MAHE Post graduate research grant
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Aditya Pradeep Karnad

Kasturba Medical College and Hospital, Manipal

研究点 (1)

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