Metabolic Syndrome
Conditions
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.
Interventions
DRUGGynostemma
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.
OTHERSpinach
For the spinach powder group, each patient will take spinach powder with nearly no saponin content, 3 times a day for 3 months.
Sponsors
First Affiliated Hospital Xi'an Jiaotong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change of weight | From date of randomization to the last follow-up, once a month, assessed up to 3 months. | Kg |
| change of blood lipid level | From date of randomization to the last follow-up, once a month, assessed up to 3 months. | mmol/L |
| change of blood glucose level | From date of randomization to the last follow-up, once a month, assessed up to 3 months. | mmol/L |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change of serum insulin level | The date of first enrollment and 3 months after the intervention. | pmol/L |
| change of waistline and hipline | From date of randomization to the last follow-up, once a month, assessed up to 3 months. | cm |
| change of serum C peptide level | The date of first enrollment and 3 months after the intervention. | pmol/L |
| change of blood pressure | From date of randomization to the last follow-up, once a month, assessed up to 3 months. | mmHg |
| change of glucose tolerance | The date of first enrollment and 3 months after the intervention. | mmol/L |
Countries
China
Contacts
Primary ContactYanan Wang, professor
Backup ContactQian Li, master
Outcome results
None listed