None listed
Conditions
Interventions
Others(Medical Food) : Intervention is divided into a test group and a control group.
Test Group (Medical Food Group)
Participants will receive a diabetes-specific medical food product, with educatio
Sponsors
Kyung Hee University Global Campus
Dankook Univeristy Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Individuals diagnosed with type 2 diabetes mellitus (T2DM) with HbA1c levels between 6.5% and 9.0% on clinical laboratory testing. 2. Individuals currently being treated with oral hypoglycemic agents, including metformin. 3. Individuals who have voluntarily provided written consent to participate in this clinical trial.
Exclusion criteria
Exclusion criteria: 1. Individuals under the age of 19 at the time of obtaining written informed consent. 2. Individuals unable to complete the questionnaire by themselves. 3. Individuals diagnosed with type 1 diabetes mellitus (T1DM) or other types of diabetes. 4. Individuals with severe nutritional imbalances, either undernutrition (BMI 2 × the upper limit of normal (ULN) for the institution. * AST, ALT, or total bilirubin > 2 × the ULN for the institution. 8. Individuals who have experienced changes in the combination or dosage of oral hypoglycemic agents within four weeks (28 days) prior to visit 1, or who are expected to require such changes during the study period. 9. Individuals with a history of hypoglycemia on three or more occasions within four weeks (28 days) prior to visit 1 (screening start date). 10. Individuals who have received insulin therapy or GLP-1 receptor agonist therapy within three months (90 days) prior to visit 1 (screening start date). 11. Individuals who have experienced changes in the dosage of thyroid medications within three months (90 days) prior to visit 1 (screening start date). * Those on a stable dose are eligible for participation. 12. Individuals with a history of infection within three months (90 days) prior to visit 1 (screening start date) or who are currently infected. 13. Individuals who have received immunosuppressants (excluding topical or non-systemic agents), loop diuretics, or anti-obesity medications for weight loss within three months (90 days) prior to visit 1 (screening start date). 14. Individuals with gastrointestinal diseases (such as irritable bowel syndrome, inflammatory bowel diseases like Crohn’s disease or ulcerative colitis, pancreatitis) within three months (90 days) prior to visit 1, those currently affected, or those who have undergone intestinal resection surgery. 15. Individuals with a history of malignant tumors within the past three years. * Those who have been assessed as being in complete remission (CR or pCR) and have remained recurrence-free for at least five years since the date of remission are eligible. 16. Individuals unable to wear a continuous glucose monitoring (CGM) sensor (FreeStyle Libre® 2). 17. Individuals who are expected to require CT, X-ray, or MRI scanning within two weeks after CGM sensor attachment. 18. Individuals unable to use the CGM smartphone application (FreeStyle LibreLink). 19. Individuals who have undergone bariatric or metabolic surgery (such as sleeve gastrectomy) or are scheduled to undergo significant surgery during the study period. 20. Individuals with a history of alcohol abuse, or with psychiatric disorders such as bipolar disorder, anxiety disorders, panic disorder, somatoform disorders, personality disorders, or other psychiatric conditions. 21. Pregnant or breastfeeding women, or those intending to become pregnant. 22. Individuals with a history of hypersensitivity or allergies to the test food (diet). 23. Individuals currently consuming health functional foods tha
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in HbA1c;Change in Glycated albumin;Change in Fasting Blood Sugar (FBS);Change in Lipid profile(HDL-C, LDL-C, TG);Change in Body weight, Waist circumference;measured by continuous glucose monitoring (CGM);Change in Nutrition Quotient (NQ) score for adults;Major Biomarker Changes (HOMA-ß, HOMA-IR, C-peptide, Insulin, Fructosamine, Apolipoprotein [Apo A-1, Apo B]) | — |
Countries
Korea, Republic of
Contacts
Public ContactYoo Kyung Park
Kyung Hee University Global Campus
Outcome results
None listed