Intensive Lifestyle Intervention for Remission of Metabolic Syndrome (INSLIMS)

Zhejiang University

Status: Completed

Conditions: Metabolic Syndrome

Treatments: Behavioral: Intensive Lifestyle Intervention; Behavioral: Conventional Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT04116905

LIMS

Details and patient eligibility

About

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. Furthermore, this study enables phased presentation of the findings.

Full 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.

Enrollment: 68 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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68 participants in 2 patient groups

Intensive Lifestyle Intervention

Experimental group

Description:

Participants randomized to the intensive lifestyle intervention arm will receive a structured, multi-component program consisting of both individualized counseling and group-based sessions. This intervention is specifically designed to facilitate achievement of a clinically significant 15% weight reduction and support long-term weight maintenance."

Treatment:

Behavioral: Intensive Lifestyle Intervention

Conventional Treatment

Active Comparator group

Description:

Participants in the conventional treatment arm receive structured group-based education sessions focusing on metabolic syndrome management principles and peer support, with the therapeutic goal of achieving a modest 7% weight reduction

Treatment:

Behavioral: Conventional Treatment