Double blind, randomized controlled study to evaluate the efficacy and safety of extract of leaves of Dendropanax morbiferous H. Lev on the glucose metabolism

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0004672

Enrollment

Registered

2020-01-30

Start date

2018-07-23

Completion date

Unknown

Last updated

2020-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Dietary Supplement : The ratio of 1: 1 to leaves of Dendropanax morbiferous H. Lev extract group and placebo group is randomly assigned to each group, and to take Hwangchil-tree leaf extract or place

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) 80 male and female adults aged 21 to 75 years without diabetes with fasting blood glucose levels below 126 mg / dl and glycated hemoglobin less than 6.5% 2) Person who has not received drug treatment for obesity and diabetes in the last three months 3) The person who voluntarily agreed to participate in this clinical trial

Exclusion criteria

Exclusion criteria: 1) Fasting blood glucose is 126 mg / dl or more or HbA1C 6.5% or more 2) Those who are taking drugs or dietary supplements for diabetes within the last three months and during clinical trials 3) Mental illnesses that may affect subject evaluation and investigational drugs. In particular, history such as mental disorder, depression 4) Except where the following laboratory test results are shown, which may affect the performance of the test. AST (SGOT) / ALT (SGPT) is a liver disease that is more than three times the normal upper limit -Renal impairment with creatinine levels above 1.5 mg / dl 5) Those who have been taking glucocorticoids that affect blood sugar within the last 3 months 6) Drug abuser or historical person (including alcohol) 7) History of serious illness that can recur during or immediately after clinical trials 8) Those who need treatment due to hyperthyroidism or hypothyroidism. (However, hypothyroidism that does not require treatment with a TSH of less than 10 µg / dl is not applicable.) In addition, persons deemed impossible to participate in clinical research by researchers

Design outcomes

Primary

Measure	Time frame
Compare glucose changes;Compare insulin changes;Compare c-peptide changes;Changes in HOMA-IR Measured with Fasting Glucose and Insulin;Changes in HOMA-beta Measured with Fasting Glucose and Insulin	—

Secondary

Measure	Time frame
Comparison of Changes in Glycoalbumin;Comparison of Changes in HbA1C;Comparison of Changes in Weight Change;Comparison of changes in body fat;Comparison of waist circumference;Comparison of Total Cholesterol Change;Comparison of Triglyceride Changes;Comparison of LDL-C;Comparison of LDL-C	—

Countries

Korea, Republic of

Contacts

Public Contactjunghwa lee

Kyung Hee University Hosipital at Gangdong

Outcome results