Effect of motilitone on gastrointestinal symptoms in patients with type 2 diabetes mellitus
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0007103
- Lead Sponsor
- Kyung Hee University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 60
1) Adults 18 years of age or older
2) Those with type 2 diabetes who are being controlled with oral medications (biguanide, sulfonylurea, alpha-glucosidase inhibitor, thiazolidinedione, meglitinide, metformin combination, DPP-4 inhibitor)
3) Those who have not changed their diabetes medication in the last 3 months, HbA1c < 9% or less, and have a change within ±0.5 from HbA1C before 3 months
4) Those diagnosed with postprandial distress syndrome of functional dyspepsia according to Rome IV diagnostic criteria (in case of postprandial bloating or early feeling of fullness more than 3 days a week, beginning 6 months ago and lasting for 3 months or more )
5) Those who have agreed to participate in this exam
1) Those who are being treated with insulin preparations or GLP1 receptor agonists for the treatment of diabetes
2) In case of diabetic renal dysfunction or diabetic retinopathy
3) Those who have confirmed organic digestive diseases (eg gastric ulcer, duodenal ulcer, esophageal cancer, gastric cancer, enteritis, colitis, etc.)
4) If you have had gastrectomy or vagus nerve resection in the past, and if other lesions that can cause gastrointestinal symptoms are found
5) If you are taking drugs that may affect the exercise evaluation of the digestive system
6) In case of impaired liver function (AST, ALT 2.5 times the upper limit of normal)
7) Persons with serious active medical conditions that may affect quality of life measures (thyroid disease, wasting or infectious disease, active cancer disease, acute respiratory disease, chronic active rheumatism and autoimmune disease, heart failure (NYHA II - IV) Or myocardial infarction, those with cardiovascular stents, etc.)
8) Pregnant, lactating, and women of childbearing age who do not use appropriate contraceptive methods
9) Others, those who are judged inappropriate by the principal investigator or the person in charge
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Amount of improvement in the symptom questionnaire (NDI-K symptom score)
- Secondary Outcome Measures
Name Time Method Amount of improvement in the symptom questionnaire (NDI-K symptom score)