Diarrhea due to metformin hydrochloride tablets
Conditions
Interventions
Control group:Transcutaneous Auricular Marginal Non-Vagus Nerve Stimulation
Sponsors
Wangjing Hospital China Academy of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Diagnostic criteria for diabetes mellitus: one of the following: fasting (no caloric intake for at least 8-14 hours) venous or capillary plasma glucose (FPG) >126 mg/dl (7.0 mmol/L); venous plasma glucose >200 mg/dl (11.1 mmol/L) 2 hours after a meal; capillary plasma glucose >220 mg/dl 2 hours after a meal ( 12.2 mmol); random blood glucose >200 mg/d1 (11.1 mmol/L); glycosylated hemoglobin (HbAIc) >6.5%. Diagnostic criteria for metformin-induced diarrhea According to previous high-quality literature studies the possibility of metformin-associated diarrhea should be considered when diarrhea has recently been applied or is being applied to more than 500mg bid of metformin without diarrhea prior to use and other causes of diarrhea are ruled out such as chronic diarrhea food poisoning diabetic autonomic nervous dysfunction ulcerative colitis Crohn's disease and so on. The grading of diarrhea was formulated according to the Guiding Principles for Clinical Research of New Chinese Medicines (for Trial Implementation). (1) Mild diarrhea: unformed stools 3-4 times per day; (2) Moderate diarrhea: loose stools 5-10 times per day; (3) Severe diarrhea: watery stools more than 10 times per day. 1) People who meet the above diagnostic criteria including those with mild and moderate diarrhea; 2) Age between 18 and 80 years old men and women are not limited; 3) Good compliance to the researchers' observation and treatment; 4)Patients who signed the informed consent to participate in this study voluntarily; 5) Diet exercise lifestyle and glucose-lowering program fixed and stable blood glucose fasting blood glucose coefficient of variation <16% 3 days before and on the day of treatment. 6) Body mass index (BMI) between 18.5 kg/m² and 40 kg/m². Note: Subjects who meet the above 5 items at the same time can be included in this study.
Exclusion criteria
Exclusion criteria: 1) Acute and chronic diarrhea caused by gastrointestinal pathology and diseases of the liver gallbladder and pancreas as well as dysentery cholera and systemic diseases poisoning parasitic infections malignant tumors gastric bypass surgery diabetes mellitus and so on as verified; 2) Combined ketoacidosis cardiovascular and cerebrovascular diabetes mellitus other than endocrine hematopoietic system and other serious diseases and psychiatric patients; 3)People taking proton pump inhibitors H2 receptor blockers probiotics antibiotics or others that may affect the intestinal microbiota; 4)Pregnant planning to be pregnant or breastfeeding women 5) Those with excessive fluctuations in blood glucose; 6) Exclusion of severe diarrhea; 7) Those with severe skin lesions in the auricular region and absence of auricles; 8) Those who are fearful of the intervention or intolerant to conventional current stimulation; 9) Those with known hypersensitivity to metformin hydrochloride tablets or those who should not take them; 10) Those who are participating in other clinical trials or those who have difficulty understanding and cooperating with the full trial treatment during the study; Note: Patients who meet any of the above criteria should be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Questionnaire on Characteristics and Severity of Metformin Intolerance; | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum Diamine Oxidase;D - Lactate;insulin resistance index;Bristol Fecal Characterization Scale;Connecting Peptide;Glycated Albumin;Defecation emergencies;Quality of Life Scale;Tumor Necrosis Factor-a;2-Hour Postprandial Blood Glucose;Fasting Blood Glucose;Bile Acid;insulin sensitivity index;Interleukin-10;Interleukin-6;GLP-1;5-Hydroxytryptamine; | — |
Countries
China
Contacts
Public Contactgexiaolei
Wangjing Hospital China Academy of Traditional Chinese Medicine Huajiadi Street Chaoyang District Beijing China
Outcome results
None listed