Status:
COMPLETED
Lifestyle Intervention Trial in High Metabolic Risk Chinese
Lead Sponsor:
Chinese Academy of Sciences
Collaborating Sponsors:
Sir Run Run Shaw Hospital
Conditions:
Metabolic Syndrome
Obesity
Eligibility:
All Genders
20-65 years
Phase:
NA
Brief Summary
In this single-blind, randomized trial, 395 eligible volunteers, who have higher metabolic syndrome (MetS) risk and aged 20-65 years, will be assigned to one of two smartphone-based lifestyle interven...
Detailed Description
Metabolic syndrome, a cluster of multiple metabolic disturbances, including central obesity, dyslipidemia, hypertension, and hyperglycemia, is associated with 2-5-fold heightened risks of CVD and T2D....
Eligibility Criteria
Inclusion
- Volunteers at high metabolic risk aged 20-65 who didn't participate in other studies in 3 months before the current research, having a certain level of education and normal cognitive ability, taking good care of himself/herself. MetS risk factors were identified by the definition proposed by the International Diabetes Federation criteria for Chinese adults. Participants should have central obesity (waist circumference ≥90 cm in men or ≥80 cm in women).
Exclusion
- Fasting glucose\>7.0mmol/L after taking insulin or other blood glucose-lowering drugs
- Diagnosed phase three hypertension or can't lowering SBP under 160mmHg after anti-hypertension drugs
- Fasting blood TG≥ 5.7 mmol/L or fasting LDL-C≥ 4.9 mmol/L after taking lipid-lowering drugs
- Pregnancy or lactation
- Obvious drug changing in three months before research
- History of drug or alcohol abuse or other substance abuse (Alcohol abuse is defined as more than 40 g/day of alcohol for woman, and more than 80g/day for man)
- Severe kidney and liver diseases (blood biomarkers such as alt, serum creatinine is 1.5 times over the scope of normal setting)
- Severe Gastrointestinal diseases (such as severe diarrhea, constipation, severe digestive tract inflammation, active peptic ulcer, acute cholecystitis, etc.)
- Having surgeries within one year before research such as heart stents implanted surgery (expect for appendicitis or hernia operation)
- Severe cardiovascular disease (e.g., heart failure, myocardial infarction, cerebral infarction, and acute myocarditis, severe arrhythmia, received the intervention therapy, etc.)
- Cancer or receiving radiotherapy and chemotherapy within 5 years
- Severe pituitary or thyroid diseases
- Suffering from AIDS, hepatitis A, hepatitis B and other infectious diseases
- Mental disorders or current use of antidepressants
Key Trial Info
Start Date :
December 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
395 Patients enrolled
Trial Details
Trial ID
NCT04714723
Start Date
December 27 2020
End Date
December 31 2023
Last Update
February 9 2024
Active Locations (1)
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1
Sir Run Run Shaw Hospital;Hangzhou Dianzi University;China Jiliang University; Zhejiang Sci-Tech University
Hangzhou, Zhejiang, China, 310016