NCT03805191

A Study for Sufficient Acarbose Decreased Glucose Excursion in Type 2 Diabetic Patients

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 900 (estimated)
• Sponsor: Qilu Hospital of Shandong University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Type 2 Diabetes Mellitus
• Poor Glycemic Control

Timeline

• Start date: 2019-01-01
• Primary completion: 2020-11-30
• Completion: 2022-12-30
• First posted: 2019-01-15
• Last updated: 2019-04-12

Locations

1 site across 1 country: China