This is a multicentre observational study to investigate the improvement in glucose fluctuation of sufficient acarbose therapy on type 2 diabetes patient with high blood glucose fluctuation
Acarbose competitively inhibits the a-glycosidase on the surface of epithelial cells from the duodenum and small intestine, delays the metabolism and assimilation of carbohydrates, and thus effectively decreases postprandial blood glucose(PBG) as well as the risk of hypoglycemia before the next meal.Acarbose is now used as the preferred drug for some patients with prediabetes and newly diagnosed type 2 diabetes millitus(T2DM).This study aims to investigate the glycemic excursions with different courses and glycated hemoglobin A1c(HbA1c) levels after treated three months with acarbose.To minimize gastrointestinal side effects,starting dosage of acarbose of 50 mg is given orally three times daily for 10 days(with the first bite) of each main meal. Glycemic excursions are evaluated using the mean amplitude of glycemic excursions (MAGE), the postprandial glycemic excursions (PPGE) and the largest amplitude of glycemic excursions (LAGE).Freestyle Libre flash glucose monitoring system (FGMS,Abbott Laboratories,USA) was administered in this study. According to the standard Freestyle Libre Pro operating guidelines, the FGMS is installed in all participants to monitor glucose levels of interstitial fluid for 14 consecutive days. The glucose sensor is inserted into the subcutaneous tissue of upper arm at 8:00-9:00 in the morning.Glucose concentrations at 7 preset times per day (before meals, 2-h after meals and at bedtime) were determined with VivaChek Ino Smart(VivaChek Laboratories, Inc., USA) every two weeks.Four days before using acarbose and five weeks after using acarbose, FGMS was using to monitor the continuous glucose.MAGE was calculated for each subject by taking the arithmetic mean of FGM values increased or decreased (from nadirs to peaks or vice versa) when both ascending and descending segments exceeded the value of one standard deviation (SD) of the FGM values for 24-h period.The primary endpoint of the study is the extent of change in MAGE.Secondary endpoints are changes in PPGE,LAGE and HbA1c. Gene polymorphism is detected for enrolled patient with poor acarbose effect.
Study Type
OBSERVATIONAL
Enrollment
900
Qilu Hospital of Shandong University
Jinan, China
RECRUITINGThe extent of change in MAGE
Mean absolute glucose excursions (MAGE) was calculated to assess intraday glucose variability. The difference between the consecutive peaks and nadirs exceeding one standard deviation (SD) of the daily mean blood glucose (MBG) level was expressed as absolute glucose excursion (AGE). MAGE was an arithmetic mean of all absolute AGEs.The average MAGE of the last three days of the eighth week are compared with the baseline(The average MAGE of the three days before using acarbose).The extent of change in MAGE is numerical value to to assess glucose variability.
Time frame: 8 weeks
The extent of change in PPGE,LAGE
Postprandial glucose excursion (PPGE) is calculated as the peak value of glucose after meals minus the glucose level at the beginning of each meal to evaluate the influence of meals on glucose fluctuation.Largest amplitude of glycemic excursions (LAGE) is calculated as the maximum minus the minimum blood glucose levels measured in one day.The average PPGE、LAGE of the last three days of the eighth week compared with the baseline(The average PPGE、LAGE of the three days before using acarbose).
Time frame: 8 weeks
The control rate of HbA1c
When HbA1c\<7% was considered as the criteria, the control rate of HbA1c after 12 weeks.
Time frame: 12 weeks
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