Intensive Lifestyle Intervention for Remission of Metabolic Syndrome
- Conditions
- Metabolic Syndrome
- Registration Number
- NCT04116905
- Lead Sponsor
- Second Affiliated Hospital, School of Medicine, Zhejiang University
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 68
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method The remission rate of metabolic syndrome 12 months Participants are considered to have achieved metabolic syndrome remission when they meet ≤2 of the following 5 diagnostic criteria:
1. Waist circumference ≥85 cm (men) / ≥80 cm (women);
2. Fasting triglycerides ≥1.7 mmol/L or current lipid-lowering therapy;
3. HDL cholesterol \<1.04 mmol/L (men) / \<1.30 mmol/L (women);
4. Systolic BP ≥130 mmHg and/or diastolic BP ≥85 mmHg, or diagnosed hypertension with antihypertensive treatment;
5. Fasting glucose ≥5.6 mmol/L, or diagnosed type 2 diabetes with glucose-lowering treatment.
Remission is defined as sustained resolution of ≥3 criteria.The proportion of participants achieving 15% weight loss from baseline 12 months The proportion of participants achieving 15% weight loss from baseline
- Secondary Outcome Measures
Name Time Method Remission of hypertension 12 months The proportion of participants achieving target blood pressure control (either \<130/85 mmHg or \<140/90 mmHg) without antihypertensive medication.
Remission of hyperglycemia 12 months The proportion of participants achieving fasting plasma glucose \<5.6 mmol/L without glucose-lowering medication.
Remission of low HDL-C 12 months The sex-specific proportion achieving therapeutic HDL-C targets (≥1.04 mmol/L in males; ≥1.30 mmol/L in females) without lipid-modifying therapy.
Remission of central obesity 12 months Proportion meeting gender-stratified waist circumference criteria (males \<85 cm; females \<80 cm).
Remission of hypertriglyceridemia 12 months The proportion of participants achieving triglyceride levels \<1.7 mmol/L without lipid-lowering therapy.
Trial Locations
- Locations (1)
The Second Affiliated Hospital of Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
The Second Affiliated Hospital of Zhejiang University School of Medicine🇨🇳Hangzhou, Zhejiang, China