Type 2 diabetes patients with poor blood glucose control Nutritional, Metabolic, Endocrine
Conditions
Interventions
The participants are randomized 1:1:1 into three groups. The random number sequence is generated using the PROC PLAN command in SAS 9.4 (SAS Institute, Cary, NC, USA) and enclosed in opaque anonymous
Sponsors
First Affiliated Hospital of Harbin Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged between 18 and 70 years old, regardless of gender 2. Body mass index (BMI) between 19 and 30kg/m2 3. Diagnosed as type 2 diabetes according to the diagnostic criteria for type 2 diabetes formulated by the 1999 World Health Organization 4. Type 2 diabetes patients with poor blood glucose control 7% = HbA1c = 10% 5. Able to understand the procedures and methods of this clinical study, participate voluntarily and sign the informed consent form
Exclusion criteria
Exclusion criteria: 1. Ineffective, allergy or intolerance to a-glucosidase inhibitors 2. Severe diabetic complications 3. Secondary diabetes mellitus, specific types of diabetes, type 1 diabetes 4. Chronic gastrointestinal dysfunction, obvious digestive and absorption disorders, as well as other endocrine diseases, such as hyperthyroidism, Cushing syndrome, acromegaly, etc 5. Patients with diseases that may worsen due to flatulence (such as Roeheld syndrome, severe hernia, intestinal obstruction, after gastrointestinal surgery and intestinal ulcer) 6. Unstable angina pectoris within half a year, have serious heart diseases and are likely to die in the treatment and follow-up period 7. People with mental and neurological disorders who cannot correctly express their will 8. Alcoholics, drug abusers and addicts 9. Women of childbearing age who are pregnant, lactating, intending to be pregnant or positive in a pregnancy test (urine HCG or blood HCG), and cannot take effective contraceptive measures during the test (effective contraceptive measures include sterilization, intrauterine device, oral contraceptives etc 10. Those who have participated in clinical trials of other drugs or medical devices in the past three months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood glucose levels measured using continuous glucose monitoring (CGM) to detect changes in blood glucose fluctuation at baseline and after 6 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Fasting, 1 hour postprandial and 2 hours postprandial blood glucose levels, blood glucagon-like peptide 1 (GLP-1) levels, inflammatory factors (C-reactive protein (CRP), IL-6, etc.), oxidative stress (MDA, SOD, etc.), and blood lipid parameters measured in venous blood using standard methods at baseline and 6 weeks 2. Glycosylated hemoglobin and glycosylated albumin measured in venous blood using standard methods at baseline and 6 weeks 3. Treatment satisfaction measured using the Diabetes Treatment Satisfaction Questionnaire (DTSQ) at baseline and 6 weeks 4. Quality of life measured using the Chinese Normal Audit of Diabetes-Dependent Quality of Life (CN-ADDQoL) at baseline and 6 weeks | — |
Countries
China
Contacts
Public ContactMeng Ziyu
Outcome results
None listed