Intensive Lifestyle Intervention for Remission of Metabolic Syndrome

Last updated: April 10, 2025
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Overall Status: Completed

Phase

N/A

Condition

Metabolic Syndrome

Diabetes Prevention

High Cholesterol (Hyperlipidemia)

Treatment

Intensive Lifestyle Intervention

Conventional Treatment

Clinical Study ID

NCT04116905
LIMS
  • Ages 18-60
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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. (Ifwith type 2 diabetes, the process of the disease should not exceed 6 years, with thelevel of C-P ≥3/4 of the lower limit of limit; if with hypertension, BP ≤ 180/110mmHg without anti-hypertensive agent, or BP ≤160/100 mmHg with 1-2 kinds ofanti-hypertensive agents, or BP ≤140/90 mmHg with 3-4 kinds of anti-hypertensiveagents; if with hyper-triglyceridemia, TG ≤ 11.2 mmol/L without lipid-loweringagent, or TG ≤ 5.6 mmol/L with lipid-lowering agent.)

  • Han Chinese

  • Willingness to participate

Exclusion

Exclusion Criteria:

  • Participants with metabolic syndrome caused by other secondary factors (geneticdiseases related to obesity and hyperlipidemia, Cushing's syndrome, drug-inducedobesity 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 ofdiabetes;

  • Participants with BP ≥ 180/110 mmHg, or malignant hypertension;

  • Participants with previous severe gastrointestinal diseases;

  • Participants with significant dysfunction of heart, liver, kidney and systemicorgans (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 andneurological disorders;

  • Pregnant or lactating women; those who have planned to give birth within the past 1year;

  • Participants with special dietary requirements, or with soy products, milk and otherdaily food allergies;

  • Participants in other clinical trials.

Study Design

Total Participants: 68
Treatment Group(s): 2
Primary Treatment: Intensive Lifestyle Intervention
Phase:
Study Start date:
October 01, 2020
Estimated Completion Date:
October 31, 2022

Study 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.

Connect with a study center

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang 310009
    China

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.