Intensive Lifestyle Intervention for Remission of Metabolic Syndrome

NCT04116905 | Completed

• 1 other identifier: LIMS
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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

Conditions

Metabolic Syndrome

Keywords

Metablolic syndrome; remission; life style; weight loss

Outcome Measures

Primary Outcomes (2)

• The remission rate of metabolic syndrome

  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.

  12 months

• The proportion of participants achieving 15% weight loss from baseline

  The proportion of participants achieving 15% weight loss from baseline

  12 months

Secondary Outcomes (5)

• Remission of hypertension

  12 months

• Remission of hyperglycemia

  12 months

• Remission of hypertriglyceridemia

  12 months

• Remission of low HDL-C

  12 months

• Remission of central obesity

  12 months

Study Arms (2)

Intensive Lifestyle Intervention

EXPERIMENTAL

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."

Behavioral: Intensive Lifestyle Intervention

Conventional Treatment

ACTIVE COMPARATOR

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

Behavioral: Conventional Treatment

Interventions

Intensive Lifestyle Intervention BEHAVIORAL

The intensive lifestyle intervention program employs a structured, multi-component approach under professional supervision to achieve and sustain 15% weight reduction from baseline. This 12-month intervention features: 1. A weight loss phase (months 1-5) incorporating: Individualized calorie restriction using partial meal replacement (carbohydrate energy supply ratio is 20\~25%, and the daily calorie intake is 22.5\*70% kcal/kg/d); exercise recommends at least 150 min of moderate intensity and 2 to 3 resistance training per week; with monthly follow-ups. 2. A maintenance phase (months 6-12) focusing on: A Healthy, balanced diet, total daily calorie intake is 20-25 kcal/kg/d; exercise recommendations at least 150 minutes of moderate intensity and 2-3 resistance training per week; with follow-ups every 2 months. 3. Digital health integration: Mobile application-based monitoring of metabolic parameters; real-time feedback and adherence tracking.

Intensive Lifestyle Intervention

Conventional Treatment BEHAVIORAL

The conventional treatment arm receive standardized metabolic syndrome management through monthly group education sessions and peer support, with a target of 7% weight reduction from baseline. The program incorporates: 1. A weight loss phase (months 1-5) incorporating: Structured lifestyle education; limit the total energy diet (total daily calorie intake is 22.5\*85% kcal/kg/d), with carbohydrates, fat, proteins accounting for 45-55%, 20-30%, and 20-30%, respectively, for the daily energy intake.; physical activity(150 min medium intensity exercise and 2 to 3 resistance training); with monthly follow-ups; 2. A maintenance phase (months 6-12) focusing on: Healthy balanced diet, total daily calorie intake is 20\~25 kcal/kg/d; physical activity(150 min medium intensity exercise and 2 to 3 resistance training);with follow-ups every 2 months; 3. Digital health integration: Mobile application-based monitoring of metabolic parameters; real-time feedback and adherence tracking.

Conventional Treatment

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

Location

MeSH Terms

Conditions

Metabolic Syndrome; Weight Loss

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Pengfei Shan, MD, PhD

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

• Yuezhong Ren, MD

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2019
• First Posted: October 7, 2019
• Study Start: October 1, 2020
• Primary Completion: August 31, 2022
• Study Completion: October 31, 2022
• Last Updated: December 31, 2025

Record last verified: 2019-09

Locations

CN (1)