Phase
Condition
Metabolic Syndrome
Diabetes Prevention
High Cholesterol (Hyperlipidemia)
Treatment
Intensive Lifestyle Intervention
Conventional Treatment
Clinical Study ID
Ages 18-60 All Genders
Study Summary
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
Study Description
Connect with a study center
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang 310009
ChinaSite Not Available
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