None listed
Conditions
Interventions
Drug : This study is a single-arm, single-sequence clinical trial, where there is no difference in intervention between groups. The intervention used in this study is Glucophage XR (Metformin Hydrochl
Sponsors
Chungnam National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy volunteers aged 19 to 50 years at the time of screening. 2. Individuals with a body mass index (BMI) of =30.0 kg/m². 3. Individuals who have received a detailed explanation of the study, fully understood the information, voluntarily decided to participate, and provided written informed consent to comply with study requirements. 4. Individuals who agree to use medically recognized effective contraception from the first administration of the investigational product until the last study visit. Additionally, male participants must agree not to donate sperm, and female participants must agree not to participate in egg donation or breastfeed during the study period. *Medically recognized effective contraception includes intrauterine devices (IUD, IUS), vasectomy, tubal ligation, or the combined use of at least two barrier methods (e.g., male condom, female condom, cervical cap, diaphragm, contraceptive sponge). 5. Individuals who have had bowel movements 3 to 7 times per week for the past four weeks prior to screening, classified as Bristol Stool Form Scale (BSFS) Type 3 (sausage-like stool with cracks on the surface) or Type 4 (smooth, soft sausage or snake-like stool). 6. Individuals deemed suitable for study participation based on physical examination, clinical laboratory tests, and medical history assessment conducted by the investigator.
Exclusion criteria
Exclusion criteria: 1) Individuals with a history or current diagnosis of clinically significant diseases affecting the liver (including viral hepatitis), kidneys, nervous system, immune system, respiratory system, endocrine system, cardiovascular system, hematologic system, oncology, or psychiatric disorders (e.g., mood disorders, obsessive-compulsive disorder). 2) Individuals with gastrointestinal disorders that may affect drug absorption (e.g., Crohn’s disease, peptic ulcers) or a history of gastrointestinal resection surgery (except for simple appendectomy or hernia surgery). 3) Individuals with a history or current presence of any of the following conditions that may raise concerns regarding the use of the investigational product: - A history of or current hypersensitivity reaction to the investigational product or any of its components. - A history of or current hypersensitivity reaction to non-biguanide drugs. - A history of diabetic coma or pre-coma, type 1 diabetes, lactic acidosis, metabolic acidosis, or ketoacidosis. - A history of or current severe infection, pre-/post-surgical condition, or moderate trauma. - A history of or current heart failure. - Individuals currently taking sulfonylurea drugs. - A history of or current pituitary insufficiency or adrenal insufficiency. - Individuals with malnutrition, starvation, irregular food intake, insufficient food intake, or frailty. - Individuals who have engaged in intense physical exercise. - Individuals with dehydration, severe infection, cardiovascular collapse (shock), acute myocardial infarction, or sepsis, which may affect renal function. - Individuals undergoing intravenous radiographic contrast studies (e.g., intravenous urography, cholangiography, angiography, contrast-enhanced CT scans) or planning to undergo such procedures during the study period. - Individuals scheduled for surgery during the study period (except for minor procedures that do not restrict food or fluid intake). - Individuals with a history of pulmonary infarction, severe pulmonary dysfunction, hypoxemia-prone conditions, dehydration, diarrhea, vomiting, or other gastrointestinal disorders. 4) Individuals with systolic blood pressure below 90 mmHg or above 150 mmHg, or diastolic blood pressure below 60 mmHg or above 90 mmHg at screening. 5) Individuals with any of the following abnormal laboratory test results at screening (including re-tests): - Hemoglobin (Hb) 2.0 × the upper reference limit - ?-GT > 1.5 × the upper reference limit - Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73? (calculated using the Modification of Diet in Renal Disease (MDRD) formula) 6) Individuals who test positive for any of the following serological markers: RPR Ab, anti-HIV (AIDS), HBs Ag, HCV Ab. 7) Individuals who have taken prescription antibiotics, probiotics (registered as health functional foods), immunosuppressants, steroids, prokinetics (e.g., mosapride, metoclopramide), or antidiarrheal agents (e.g., loperamide, bismuth subsalicylate) within one month before screening. 8) Individuals who have consumed grapefruit-containing foods or more than 5 units/day of caffeine within three months before the first dose or plan to consume these substances within 48 hours before the first dose and until the last study visit. 9) Individuals who have consumed alcohol exceeding
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Safety and Tolerability (Adverse Events, Physical Examination, Vital Signs, Electrocardiogram, Clinical Laboratory Tests) | — |
Primary
| Measure | Time frame |
|---|---|
| Blood leptin receptor mRNA expression level;Stool gut microbiota composition;Blood leptin hormone;Triglyceride;Low density lipoprotein cholesterol;High density lipoprotein cholesterol;Fasting glucose;Plasma metabolites | — |
Countries
Korea, Republic of
Contacts
Public ContactPark Yechan
Chungnam National University Hospital
Outcome results
None listed