Intensive Lifestyle Intervention for Remission of Metabolic Syndrome (INSLIMS)

Zhejiang University

Status: Completed

Conditions: Metabolic Syndrome

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

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.

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