intensive lifestyle intervention for remission of metabolic syndrome

Conditions: Metabolic Syndrome

Summary: this is a randomized, prospective clinical trial investigating metabolic syndrome in overweight or obese chinese individuals. the study aims to evaluate the efficacy of a structured intensive lifestyle intervention program in achieving significant weight reduction (targeting 15% weight loss) and promoting metabolic syndrome remission. additionally, the research will explore the potential mechanisms underlying these therapeutic effects.

background: metabolic syndrome is a global public health concern, with prevalence rates ranging from 10% to 84% across different populations. it is strongly associated with multiple chronic non-communicable diseases, including type 2 diabetes, cardiovascular diseases, non-alcoholic fatty liver disease, polycystic ovary syndrome, and certain cancers. notably, obesity plays a central role in the development of metabolic syndrome, and substantial evidence supports the benefits of significant weight loss in improving its components. currently, there is a lack of research on lifestyle interventions aimed at weight loss to alleviate metabolic syndrome in affected populations. study design: this study is a single-center, prospective, randomized controlled trial. metabolic syndrome (mets) subjects aged 18-60 years were enrolled and randomly assigned to either an intensive lifestyle intervention group (a low-carbohydrate diet combined with physical exercise, target weight loss of 15%) or a conventional lifestyle intervention group ( energy-restricted diet combined with physical exercise, target weight loss of 7%). participants underwent a 5-month weight-loss intervention (with monthly follow-ups) followed by a 7-month weight-maintenance phase (with follow-ups every 2 months). during the follow-up period, anthropometric and laboratory parameters were regularly monitored.

Eligibility criteria:
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 ≥1.7 mmol/l or with lipid-lowering treatment; hdl\<1.04 mmol/l(male) /1.3 mmol/l (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 ≥ 4 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.

Keywords: metablolic syndrome remission life style weight loss