Diabetic constipation, Functional constipation
Conditions
Interventions
taVNS group (Functional constipation group):taVNS intervention therapy
Pseudo-taVNS group (Functional constipation group):Current-free taVNS intervention
taVNS combined with basic diabetes treatment group (Diabetic constipation group):taVNS combined with basic diabetes treatment
Pseudo-taVNS combined with basic diabetes treatment group (Diabetic constipation group):Pseudo-taVNS combined with basic diabetes treatment
Diabetic constipation group:Conventional treatment
Sponsors
Binzhou Medical University Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Age 18-75 years old and gender is not limited. Patients are able to communicate well with the investigator and sign an informed consent form. Meet the diagnostic criteria for chronic constipation: the diagnosis of chronic constipation was based mainly on symptoms, which could be based on the symptoms and duration of the disease as described in the Rome IV criteria for the diagnosis of functional constipation. Diabetic constipation group should meet the inclusion criteria and diagnostic criteria of diabetes mellitus: the diagnostic criteria of diabetes mellitus issued by the American Diabetes Association in 2010 were used, i.e., one of the conditions 1-4 was met: ? glycosylated hemoglobin HbAlc>6.5%; ? fasting blood glucose FPG=7.0mmol /L. Fasting was defined as no caloric intake for at least 8h; ? 2h blood glucose at oral glucose tolerance test=11.1mmol /L (oral glucose tolerance test using 75g of anhydrous glucose according to WHO standards); ? in patients with typical hyperglycemia or with critical symptoms, random blood glucose = 11.1mmol/L; ? repeated testing in the absence of clear hyperglycemia to confirm criteria ?-?.
Exclusion criteria
Exclusion criteria: 1) Chronic constipation caused by medications, such as antidepressants, opioids, antiepileptic drugs, etc; 2) History of malignant tumors; 3) history of abdominal surgery within six months (except appendectomy, cholecystectomy and planarian delivery, etc.) 4) exclusion of organic lesions of the intestinal tract; Those with severe heart, liver, lung, kidney, blood, immune or serious diseases affecting their survival; cognitive dysfunction, aphasia, psychiatric disorders, or diseases that may affect the patient's cooperation in completing the study procedure; participation in other clinical medical studies within the past three months; those who are judged by the investigator to be unsuitable for participation in this study; patients during pregnancy, preparation for pregnancy or breastfeeding; skin diseases affecting electrode fixation or allergic to surface electrode patches; patients familiar with acupuncture treatment, acupuncture points or meridians; patients who take drugs, enemas and other laxative and laxative methods due to changes in condition or treatment needs during the study period; diabetic constipation group: those with constipation symptoms prior to the discovery of diabetes; any other constipation-causing or neurological diseases such as multiple sclerosis, flaccidity, Parkinson's disease or spinal cord injury.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of bowel movements;Bristol Stool Form (BSF);PAC-SYM score;PAC-QOL score;Number of fully voluntary bowel movements;Response rate to complete voluntary defecation;Time spent on each bowel movement;Proportion defecating with force;Proportion of bowel movements that feel incomplete;Frequency of adjuvant medication; | — |
Secondary
| Measure | Time frame |
|---|---|
| Colonic transmission test (48h/72h film);Balloon force-out test;Anorectal manometry results;HRV testing;16S sequencing of faecal enteric flora;Expression of blood-related factors;Hamilton Anxiety Scale;Hamilton Depression Scale; | — |
Countries
China
Contacts
Public ContactChen Yan
Binzhou Medical University Hospital
Outcome results
None listed