Explore the Effect of Gynostemma Pentaphyllum on Patients With Metabolic Syndrome

• Status: Not yet recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Previous research shows that gypenoside could keep blood lipid and blood sugar under control in an effective way. In this study, we intend to explore whether gypenosides have clinical improvement effects on metabolic diseases such as diabetes, hyperlipidemia, and non-alcoholic fatty liver and their cardiovascular protective potential. It is designed to recruit 150 patients with metabolic syndrome diagnosed who meet the criteria for enrollment, and randomly divide them into three groups. Gynostemma powder, with two different saponins content (12% and 8%) from Pingli County, Shaanxi Province, and spinach powder with almost no saponins were used to conduct the intervention on patients. Patients will be followed up regularly at the beginning of each month from the first enrollment until the third month. At each follow-up, data of patient's anthropometric indicators as well as clinical inspection indicators related to metabolism (blood routine, liver function, etc.) will be recorded. In addition, patient's blood, hair, urine, and stool samples will be collected to further explore the mechanism of diseases.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

Criteria

Inclusion Criteria:

• Conforms to the diagnosis criteria for metabolic syndrome (based on the MetS diagnostic criteria developed by IDF and AHA in 2009), that is, having three or more of the following traits:

1. waist circumference ≥90 cm in men or ≥80 cm in women;

2. Triglyceride level of 150 mg/dL (1.7mmol/L) or higher;

3. High-density lipoprotein (HDL) cholesterol level less than 40 mg/dL (men) or 50 mg/dL (women);

4. Blood sugar over 100 mg/dL (5.6mmol/L), or diagnosed as T2DM and received oral hypoglycemic drugs;

5. Blood pressure over 130/85 mmHg, or diagnosed as hypertension and received medication.

• Be over 18 years old or younger than 65 years old, no gender limit.

• Have a good follow-up compliance and can be followed up for more than 3 months;

• From 2 weeks before enrollment to the end of the entire trial, the drug use will not change;

• From 2 weeks before enrollment to the end of the entire trial, insulin, drugs and food that affect gastrointestinal absorption, such as Baitangping, were not used.

Exclusion Criteria:

• Pregnant and lactating women;

• Allergic or toxic reactions to gynostemma and other drugs;

• Infectious diseases such as viral hepatitis, AIDS, syphilis, tuberculosis are active;

• After drug treatment, still showing high blood sugar (fasting blood glucose higher than 200mg/dL, 11.1mmol/L) or hyperlipidemia, or hypertension (higher than 180/100 mmHg);

• Any conditions judged by the investigator that affect enrollment.