Explore the Effect of Gynostemma Pentaphyllum on Patients With Metabolic Syndrome (GPMS)

An Intervention Study of Gynostemma Pentaphyllum in Patients With Metabolic Syndrome

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.

Study Overview

• Status: Recruiting
• Conditions: Metabolic Syndrome
• Intervention / Treatment: Drug: Gynostemma; Other: Spinach

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yanan Wang, professor; Phone Number: 0086-13359242141; Email: y_wang@xjtufh.edu.cn
• Study Contact Backup: Name: Qian Li, master; Phone Number: 0086-18810920013; Email: liqian175@xjtufh.edu.cn

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710061
      • Recruiting
      • First Affiliated Hospital of Xi'an JiaoTong University
      • Contact: Bingyin Shi; Phone Number: 0086-13700298366

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Low-density lipoprotein (LDL) cholesterol ≥130 mg/dL (3.4 mmol/L ), or 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. 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) < 40 mg/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 a history of hypertension is an alternate indicator). Systolic ≥ 130 and/or diastolic ≥ 85 mmHg;
  5. Elevated fasting glucose (drug treatment for elevated glucose is an alternate indicator) ≥ 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 regimen will not change.

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 180/110 mmHg);
• Any conditions judged by the investigator that affect enrollment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High-dose group; Participants will be allowed to drink Gynostemma pentaphyllum powder containing 12% saponin, 2 g each time, 3 times a day for 3 months.	Drug: Gynostemma; Patients in the high-dose group and low-dose group will take gynostemma powder with a saponin content of 12% and 8% respectively, 3 times a day for 3 months.
Experimental: Low-dose group; Participants will be allowed to drink Gynostemma pentaphyllum powder containing 8% saponin, 2 g each time, 3 times a day for 3 months.	Drug: Gynostemma; Patients in the high-dose group and low-dose group will take gynostemma powder with a saponin content of 12% and 8% respectively, 3 times a day for 3 months.
Placebo Comparator: Placebo group; Participants will be allowed to drink a placebo of spinach powder with almost no saponin content, 2 g each time, 3 times a day for 3 months.	Other: Spinach; For the spinach powder group, each patient will take spinach powder with nearly no saponin content, 3 times a day for 3 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change of weight	Kg	From date of randomization to the last follow-up, once a month, assessed up to 3 months.
change of blood lipid level	mmol/L	From date of randomization to the last follow-up, once a month, assessed up to 3 months.
change of blood glucose level	mmol/L	From date of randomization to the last follow-up, once a month, assessed up to 3 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change of waistline and hipline	cm	From date of randomization to the last follow-up, once a month, assessed up to 3 months.
change of blood pressure	mmHg	From date of randomization to the last follow-up, once a month, assessed up to 3 months.
change of glucose tolerance	mmol/L	The date of first enrollment and 3 months after the intervention.
change of serum insulin level	pmol/L	The date of first enrollment and 3 months after the intervention.
change of serum C peptide level	pmol/L	The date of first enrollment and 3 months after the intervention.

Collaborators and Investigators

• Sponsor: First Affiliated Hospital Xi'an Jiaotong University
• Investigators: Study Chair: Bingyin Shi, First Affiliated Hospital Xi'an Jiaotong University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Anticipated): October 30, 2022
• Study Completion (Anticipated): March 1, 2023

Study Registration Dates

• First Submitted: October 15, 2021
• First Submitted That Met QC Criteria: November 3, 2021
• First Posted (Actual): November 12, 2021

Study Record Updates

• Last Update Posted (Actual): July 11, 2022
• Last Update Submitted That Met QC Criteria: July 7, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome
• Other Study ID Numbers: XJTU1AF2021LSK-273

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No