Back to resultsExplore the Effect of Gynostemma Pentaphyllum on Patients With Metabolic Syndrome (GPMS)
Primary Purpose
Metabolic Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Gynostemma
Spinach
Sponsored by
About this trial
This is an interventional treatment trial for Metabolic Syndrome
Eligibility Criteria
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:
- waist circumference ≥90 cm in men or ≥80 cm in women;
- Elevated TG (drug treatment for elevated TG is an alternate indicator) ≥150 mg/dL (1.7 mmol/L);
- 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;
- 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;
- 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.
Sites / Locations
- First Affiliated Hospital of Xi'an Jiaotong UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
High-dose group
Low-dose group
Placebo group
Arm Description
Participants will be allowed to drink Gynostemma pentaphyllum powder containing 12% saponin, 2 g each time, 3 times a day for 3 months.
Participants will be allowed to drink Gynostemma pentaphyllum powder containing 8% saponin, 2 g each time, 3 times a day for 3 months.
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.
Outcomes
Primary Outcome Measures
change of weight
Kg
change of blood lipid level
mmol/L
change of blood glucose level
mmol/L
Secondary Outcome Measures
change of waistline and hipline
cm
change of blood pressure
mmHg
change of glucose tolerance
mmol/L
change of serum insulin level
pmol/L
change of serum C peptide level
pmol/L
Full Information
NCT ID
NCT05118698
First Posted
October 15, 2021
Last Updated
July 7, 2022
Sponsor
First Affiliated Hospital Xi'an Jiaotong University
1. Study Identification
Unique Protocol Identification Number
NCT05118698
Brief Title
Explore the Effect of Gynostemma Pentaphyllum on Patients With Metabolic Syndrome
Acronym
GPMS
Official Title
An Intervention Study of Gynostemma Pentaphyllum in Patients With Metabolic Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
October 30, 2022 (Anticipated)
Study Completion Date
March 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital Xi'an Jiaotong University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
High-dose group
Arm Type
Experimental
Arm Description
Participants will be allowed to drink Gynostemma pentaphyllum powder containing 12% saponin, 2 g each time, 3 times a day for 3 months.
Arm Title
Low-dose group
Arm Type
Experimental
Arm Description
Participants will be allowed to drink Gynostemma pentaphyllum powder containing 8% saponin, 2 g each time, 3 times a day for 3 months.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Gynostemma
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Spinach
Intervention Description
For the spinach powder group, each patient will take spinach powder with nearly no saponin content, 3 times a day for 3 months.
Primary Outcome Measure Information:
Title
change of weight
Description
Kg
Time Frame
From date of randomization to the last follow-up, once a month, assessed up to 3 months.
Title
change of blood lipid level
Description
mmol/L
Time Frame
From date of randomization to the last follow-up, once a month, assessed up to 3 months.
Title
change of blood glucose level
Description
mmol/L
Time Frame
From date of randomization to the last follow-up, once a month, assessed up to 3 months.
Secondary Outcome Measure Information:
Title
change of waistline and hipline
Description
cm
Time Frame
From date of randomization to the last follow-up, once a month, assessed up to 3 months.
Title
change of blood pressure
Description
mmHg
Time Frame
From date of randomization to the last follow-up, once a month, assessed up to 3 months.
Title
change of glucose tolerance
Description
mmol/L
Time Frame
The date of first enrollment and 3 months after the intervention.
Title
change of serum insulin level
Description
pmol/L
Time Frame
The date of first enrollment and 3 months after the intervention.
Title
change of serum C peptide level
Description
pmol/L
Time Frame
The date of first enrollment and 3 months after the intervention.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
waist circumference ≥90 cm in men or ≥80 cm in women;
Elevated TG (drug treatment for elevated TG is an alternate indicator) ≥150 mg/dL (1.7 mmol/L);
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;
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;
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yanan Wang, professor
Phone
0086-13359242141
Email
y_wang@xjtufh.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Qian Li, master
Phone
0086-18810920013
Email
liqian175@xjtufh.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bingyin Shi
Organizational Affiliation
First Affiliated Hospital Xi'an Jiaotong University
Official's Role
Study Chair
Facility Information:
Facility Name
First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bingyin Shi
Phone
0086-13700298366
12. IPD Sharing Statement
Learn more about this trial
Explore the Effect of Gynostemma Pentaphyllum on Patients With Metabolic Syndrome
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