Status:
COMPLETED
Explore the Effect of Diet Intervention on Lipid Metabolism and Body Mass Index Among the Patients With Metabolic Syndrome
Lead Sponsor:
First Affiliated Hospital Xi'an Jiaotong University
Collaborating Sponsors:
The Hospital for Sick Children
Leiden University
Conditions:
Metabolic Syndrome
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The prevalence of metabolic syndrome (MetS) is increasing all over the world, which is largely related to the increasing obesity population and the current inactive lifestyle of human beings. It is a ...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Diagnosed with metabolic syndrome (i.e., more than 3 abnormal findings out of 5):
- Waist circumference ≥ 90 cm (men) or ≥ 80 cm (women).
- Elevated TG (use of medications for elevated TG is an alternate indicator) ≥ 150 mg/dL (1.7 mmol/L).
- Reduced HDL-c (use of medications for reduced HDL-c is an alternate indicator) \< 40 mg/dL (1.0 mmol/L) in males \< 50 mg/dL (1.3 mmol/L) in females.
- Elevated blood pressure (use of hypoglycemic medications is an alternate indicator). SBP ≥ 130 and/or DBP ≥ 85 mmHg.
- Elevated FBG (used of hypoglycemic medications is an alternate indicator) ≥ 100 mg/dL (5.6 mmol/L).
- Age from 18 to 65 years.
- Stable weight (change ≤ 10% current body weight) for 3 months prior to the study.
- If participates were on hypoglycemic medications, hypotensive medications, lipid-lowering medications and cardiovascular medications, dose adjustment was not permitted during the 3-month intervention.
- Exclusion criteria
- Pregnant or breast-feeding.
- Night shift workers.
- History of major diseases or related diseases, such as inflammatory disease, rheumatologic disease, adrenal disease, malignancy, type 1 diabetes, cirrhosis, chronic kidney disease, acquired immunodeficiency syndrome, eating disorder, uncontrolled psychiatric disorder and major adverse cardiovascular event.
- Current participate in other weight-management program, current on a prescribed diet for special disease or current on any drugs that effect appetite.
- History of weight-loss surgery.
Exclusion
Key Trial Info
Start Date :
July 12 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2022
Estimated Enrollment :
169 Patients enrolled
Trial Details
Trial ID
NCT04475822
Start Date
July 12 2020
End Date
June 30 2022
Last Update
July 11 2022
Active Locations (1)
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1
First Affiliated Hospital of Xi an Jiaotong University
Xi'an, Shaanxi, China, 710061