A randomized clinical study to evaluate the effect of lifestyle modifications in overweight and obese subjects with metabolic syndrome.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- NA
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change from baseline to the end of the study period in
研究概览
简要总结
The purpose of this study is to evaluate the effect of lifestyle modification in overweight and obese subjects with metabolic syndrome. A total of 120 male and female subjects of age between 20 and 70 years will be included in the study. Assessment of inclusion and exclusion criteria will be done based on clinical and laboratory investigations. The eligible subjects will be randomized as per the computer-generated randomization list. The subjects will be assigned to either TAU or TAU+ exercise, or TAU + controlled diet, or TAU + both exercise & controlled diet at a 1:1:1:1 ratio. The participants will be instructed to take treatment as usual for 12 weeks with the selected lifestyle modifications (diet, exercise, or both), which are limited to specific groups. Apart from primary and secondary outcomes, the study will also record vital signs and adverse events to evaluate the safety. The safety assessment will also include routine laboratory investigations on blood, urine and clinical chemistry at screening and the final visit of the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and female subjects aged between 20 -70 years with body mass index (BMI) of
- •34.9 kg/m
- •Subjects with any three of the following five criteria as per Harmonizing the metabolic syndrome- Joint interim statement: I. Waist Circumference greater than or equal to 90 cm for males and greater than or equal to 80 cm for females. II. Triglycerides greater than or equal to 150 mg/dL or drug treatment for hyperlipidemia. III.HDL-C less than 40 mg/dL for males and less than 50 mg/dL for females or drug treatment for low HDL-C. IV. Systolic blood pressure (SBP) greater than or equal to 130 mm Hg and /or diastolic blood pressure (DBP) greater than or equal to 85 mmHg or drug treatment for hypertension. V. Fasting plasma glucose greater than or equal to 100 mg/dL or drug treatment for diabetes mellitus.
- •Subjects willing to follow the lifestyle modifications or any other interventions as per study procedure.
- •Subjects agree to maintain the daily dairy and diet tracker.
- •Subject considered generally healthy as per health history and routine clinical investigations during screening.
- •Subjects ready to visit the site for all the assessment visit as per the study.
- •Subjects willing to provide socioeconomic status, physical activity level, education level details.
- •Ability to understand the risks/benefits of the protocol and willing to sign the written informed consent.
排除标准
- •Female subjects, who are pregnant, breast feeding or planning to become pregnant.
- •Subjects who have any physical or mental disability which could interfere the participation of the study.
- •Subjects having history of psychiatric disorder that may impair the ability of subjects to provide written informed consent.
- •History of congestive heart failure or any vascular conditions.
- •Subjects with history of sexually transmitted diseases such as HIV or any other STDs.
- •Subjects underwent treatment for COVID 19 within last 3 months or tested positive during the study will be excluded.
- •Evidence or history of clinically significant (in the judgment of the Investigator) hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, or malignancies, hypothyroidism.
- •Subjects consuming alcohol (greater than five drinks per week) and smoking greater than five cigarettes per day or use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.).
- •Any other condition that, in the opinion of the investigator, would adversely affect the subject’s ability to complete the study or its measures.
- •Subjects who are participated or currently participating in another clinical trial within 30 days prior to screening.
结局指标
主要结局
Change from baseline to the end of the study period in
时间窗: Week 0, Week 4, Week 8 and Week 12
Body weight
时间窗: Week 0, Week 4, Week 8 and Week 12
次要结局
- Change from baseline to the end of the study period in:(HOMA-IR)
- Change from baseline to the end of the study period in:(Body mass index (BMI))
- Change from baseline to the end of the study period in:(Treatment cost)
研究者
Mr Prason Kumar J
Chettinad Academy of Research and Education