Status:
COMPLETED
Intensive Lifestyle Intervention for Remission of Metabolic Syndrome
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Conditions:
Metabolic Syndrome
Eligibility:
All Genders
18-60 years
Phase:
NA
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 lifestyl...
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-commu...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2022
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT04116905
Start Date
October 1 2020
End Date
October 31 2022
Last Update
December 31 2025
Active Locations (1)
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1
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310009