Effect of intestinal electrical stimulation on plasma glucose, gastrointestinal motility, gastrointestinal hormone and autonomic nervous function in patients with type 2 diabetes.

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1900021856

Enrollment

Unknown

Registered

2019-03-13

Start date

2019-04-01

Completion date

Unknown

Last updated

2019-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Interventions

Group A:intestinal electrical stimulation-Sham stimulation

Group B:Sham stimulation-intestinal electrical stimulation

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Satisfy the American Diabetes Association criteria for type 2 diabetes; 2.Aged 18 to 70 years; 3.Meet either of the following: fasting plasma glucose =7.0mmol/L; or 2-hour plasma glucose= 11.1mmmol/L during a OGTT; or HbA1c = 6.5%; or in a patient with classic symptoms of hyperglycemia of hyperglycemic crisis, a random plasma glucose =11.1 mmol/L; 4.BMI<35kg/m2; 5.Able to give informed consent and willing to comply with the treatment.

Exclusion criteria

Exclusion criteria: 1.T1DM and using insulin treatment; 2.People with gastrointestinal diseases or currently taking drugs change the gastrointestinal motility, such as promoting gastrointestinal medicine, anticholinergic drugs or dopaminergic drugs,etc; 3.People are taking corticosteroids, beta blockers, thiazide diuretics, estrogen, thyroid hormones and other drugs have an effect on plasma glucose; 4. Have a history of pancreatitis, duodenal ulcer and inflammatory bowel disease, or existing them; 5.People in a stress state ,such as serious infection, trauma,etc; 6.Serious diabetes complications; 7.With other diseases, such as chronic heart disease, tumor, chronic kidney diseases, metabolic disease, endocrine disease, etc; 8.With coagulation disorders; 9.Have a history of gastrointestinal surgery; 10.Serious mental illness; 11.Women in menstrual period, or have been pregnant ,or preparing to conceive a child; 12.Hypersensitivity to experimental intubation operation; 13.Had implanted electrical stimulation device; 14.Smoking and drinking.

Design outcomes

Primary

Measure	Time frame
plasma glucose;GITT;gastrointestinal hormone;HRV;	—

Secondary

Measure	Time frame
inflammatory factor;	—

Countries

China

Contacts

Public ContactYao Shukun

yao_sk@163.com+86 13501008676

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026