Abstract | BACKGROUND: METHODS: Forty-six patients with poorly controlled type 2 diabetes were randomly assigned 1:1 to the YH1 or placebo group. Before the trial, all subjects had received three or more classes of OHAs with HbA1c > 7.0% (53 mmol/mol) and a body mass index ≥ 23 kg/m2. During the 12-week trial, participants continued to take OHAs without any dose or medication changes. The primary endpoint was the percentage change in HbA1c level. Per-protocol analysis was applied to the final evaluation. RESULTS: At week 12, there was an 11.1% reduction in HbA1c from baseline and a 68.9% increase in homeostatic model assessment (HOMA) of β cell function in the YH1 group, which also exhibited significant reductions in two-hour postprandial glucose (-26.2%), triglycerides (-29.5%), total cholesterol (-21.6%), low-density lipoprotein cholesterol (-17.4%), body weight (-0.5%), and waist circumference (-1.1%). The changes in fasting plasma glucose, HOMA insulin resistance and symptom scores were not significantly different between the YH1 and placebo groups. No serious adverse events occurred during this clinical trial. CONCLUSIONS: This pilot study indicates that YH1 together with OHAs can improve hypoglycemic action and β-cell function in overweight/obese patients with poorly controlled type 2 diabetes. YH1 is a safe add-on medication for OHAs and has beneficial effects on weight control and lipid metabolism. A larger study population with longer treatment and follow-up periods is required for further verification.
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Authors | Yueh-Hsiang Huang, Szu-Tah Chen, Feng-Hsuan Liu, Sheng-Hwu Hsieh, Chia-Hung Lin, Miaw-Jene Liou, Chih-Ching Wang, Chung-Huei Huang, Geng-Hao Liu, Jr-Rung Lin, Lan-Yan Yang, Tzu-Yang Hsu, Ming-Chung Lee, Chun-Teng Huang, Yi-Hong Wu |
Journal | PloS one
(PLoS One)
Vol. 14
Issue 8
Pg. e0221199
( 2019)
ISSN: 1932-6203 [Electronic] United States |
PMID | 31415655
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Drugs, Chinese Herbal
- Glycated Hemoglobin A
- Plant Extracts
- hemoglobin A1c protein, human
- shen ling bai zhu
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Topics |
- Adult
- Aged
- Araceae
(chemistry)
- Diabetes Mellitus, Type 2
(blood, drug therapy)
- Double-Blind Method
- Drugs, Chinese Herbal
(administration & dosage)
- Female
- Glycated Hemoglobin
(metabolism)
- Humans
- Male
- Middle Aged
- Obesity
(blood, drug therapy)
- Pilot Projects
- Plant Extracts
(administration & dosage, chemistry)
- Plants, Medicinal
(chemistry)
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