Intensive Lifestyle Intervention for Remission of Metabolic Syndrome
Intensive Lifestyle Intervention for Remission of Metabolic Syndrome
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.
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.
Inclusion Criteria:

 -  BMI of 27-45 kg/m2

 -  Metabolic syndrome: meet at least 3 of the following 5 criteria: Waist circumference
 ≥85 cm (male) or 80 cm (female); TG ≥150 mg/dL or with lipid-lowering treatment;
 HDL<40 mg/dL (male) /50 mg/dL (female)；SBP ≥ 130 mmHg and / or DBP ≥ 85 mmHg and / or
 with diagnosed hypertension and anti-hypertensive treatment; fasting glucose ≥ 5.6
 mmol/L and / or with diagnosed type 2 diabetes and hypoglycemic treatment. (If with
 type 2 diabetes, the process of the disease should not exceed 6 years, with the level
 of C-P ≥3/4 of the lower limit of limit; if with hypertension, BP ≤ 180/110 mmHg
 without anti-hypertensive agent, or BP ≤160/100 mmHg with 1-2 kinds of
 anti-hypertensive agents, or BP ≤140/90 mmHg with 3-4 kinds of anti-hypertensive
 agents; if with hyper-triglyceridemia, TG ≤ 11.2 mmol/L without lipid-lowering agent,
 or TG ≤ 5.6 mmol/L with lipid-lowering agent.)

 -  Han Chinese

 -  Willingness to participate

 Exclusion Criteria:

 -  Participants with metabolic syndrome caused by other secondary factors (genetic
 diseases related to obesity and hyperlipidemia, Cushing's syndrome, drug-induced
 obesity and etc.);

 -  Participants whose body weight fluctuated by more than 5 kg in the last 6 months; who
 trying to lose weight in the last 3 months; Who had used anti-obesity drugs, oral
 contraceptive, or glucocorticoids in the last 3 months;

 -  Participants with Type 1 diabetes or gestational diabetes or other types of diabetes;

 -  Participants with BP ≥ 180/110 mmHg, or malignant hypertension;

 -  Participants with previous severe gastrointestinal diseases;

 -  Participants with significant dysfunction of heart, liver, kidney and systemic organs
 (NYHA Class III or IV; ALT and / or AST ≥ 5 times the normal upper limit; GFR < 60
 ml/min) or with malignant tumor;

 -  Participants with drug abuse or alcohol addiction; with serious mental and
 neurological disorders;

 -  Pregnant or lactating women; Those who have planned to give birth within the past 1
 year;

 -  Participants with special dietary requirements, or with soy products, milk and other
 daily food allergies;

 -  Participants in other clinical trials.