Explore the Effect of Gynostemma Pentaphyllum on Patients With Metabolic Syndrome

Last updated: July 7, 2022
Sponsor: First Affiliated Hospital Xi'an Jiaotong University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Metabolic Syndrome

High Cholesterol (Hyperlipidemia)

Diabetes Prevention

Treatment

N/A

Clinical Study ID

NCT05118698
XJTU1AF2021LSK-273
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Low-density lipoprotein (LDL) cholesterol ≥130 mg/dL (3.4 mmol/L ), or conforms to thediagnosis criteria for metabolic syndrome (based on the MetS diagnostic criteriadeveloped by IDF and AHA in 2009), that is, having three or more of the followingtraits:
  1. waist circumference ≥90 cm in men or ≥80 cm in women;
  2. Elevated TG (drug treatment for elevated TG is an alternate indicator) ≥150 mg/dL (1.7 mmol/L);
  3. Reduced HDL-c (drug treatment for reduced HDL-c is an alternate indicator) < 40mg/dL (1.03 mmol/L) in males < 50 mg/dL (1.29 mmol/L) in females;
  4. Elevated blood pressure (anti-hypertensive drug treatment in a patient with ahistory of hypertension is an alternate indicator). Systolic ≥ 130 and/ordiastolic ≥ 85 mmHg;
  5. Elevated fasting glucose (drug treatment for elevated glucose is an alternateindicator) ≥ 100 mg/dL (5.6 mmol/L).
  • Be over 18 years old or younger than 80 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 treatment regimenwill not change.

Exclusion

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 higherthan 200mg/dL, 11.1mmol/L) or hyperlipidemia, or hypertension (higher than 180/110mmHg);
  • Any conditions judged by the investigator that affect enrollment.

Study Design

Total Participants: 150
Study Start date:
March 01, 2022
Estimated Completion Date:
March 01, 2023

Connect with a study center

  • First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi 710061
    China

    Active - Recruiting

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