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Intensive Lifestyle Intervention for Remission of Metabolic Syndrome — LIMS  

Metabolic Syndrome Clinical Trial

Official title:
Intensive Lifestyle Intervention for Remission of Metabolic Syndrome in Overweight or Obese Han Chinese Population

Clinical Trial Summary

It is a multi-center, randomized, prospective clinical study in metabolic syndrome with obese and overweight of Han Chinese population. The purpose of the study is to examine the effect of a programed intensive lifestyle intervention on weight loss (15%) and the remission of metabolic syndrome, and also its underlying mechanisms.

Clinical Trial Description

Metabolic syndrome is a worldwide problem to public health, with a prevalence rate of 10-84% according to previous studies. It is associated with a series of chronic non-communicable diseases, including type 2 diabetes, cardiovascular diseases, non-alcoholic fatty liver, polycystic ovary syndrome, cancer, and etc. Worth noting, obesity contributed a lot to the occurrence of metabolic syndrome, and many studies had proven the positive significance of sufficient weight loss to the improvement of components of metabolic syndrome.

The study is examining the effect of an intensive lifestyle intervention program, designed to achieve and maintain a 15% decrease in body weight by intensive calorie restriction and physical exercise, in overweight and obese volunteers with metabolic syndrome. In this program, volunteers will be supposed on very low calorie diet with partial diet replacement, followed by carefully managed food reintroduction and then weight loss maintenance. In addtion, mobile phone applications (apps) will be used during the weight loss program.

The control group will be involved in a control condition involving a program of metabolic support and education, designed to achieve and maintain a 5% decrease in body weight. Mobile phone applications (apps) will be alos adopted during the weight loss program.

The study will also test the effect of intensive lifestyle intervention on appetite, body fat, abdominal fat, gut microbiota, bone mineral density, vascular endothelial function, and etc. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04116905
Study type Interventional
Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact Pengfei Shan, MD, PhD
Phone 86-0571-87783777
Email pengfeishan@zju.edu.cn
Status Recruiting
Phase N/A
Start date May 1, 2020
Completion date May 30, 2022
View Details
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