Type 2 Diabetes Mellitus
Conditions
Keywords
DMT2, Mesenchymal Stromal/Stem Cells-Derived Exosomes, Glycemic Profile, Quality of Life, Inflammatory Biomarkers
Brief summary
This is an open-label randomized controlled trial with a pre-and-post-test control group design to evaluate the effect of Mesenchymal Stromal/Stem Cells-Derived Exosomes (MSC-Exos) as an adjunctive therapy on glycemic control and clinical outcomes in patients with Type 2 Diabetes Mellitus (T2DM). The study aims to determine if the addition of exosome therapy to standard care can improve glycemic parameters (fasting blood glucose, 2-hour postprandial glucose, HbA1c, and C-peptide), quality of life, and inflammatory biomarkers (IL-6, IL-10, D-dimer, and CRP). The study will involve 50 subjects, randomly allocated into two groups: an intervention group and a control group. The intervention group will receive standard T2DM therapy plus a combination of exosomes (1 vial Exo-HWS + 1 vial Exo-HUVEC). The control group will receive standard T2DM therapy plus 1 vial Exo-HWS. The study duration is from June to December 2025.
Interventions
BIOLOGICALMesenchymal Stromal/Stem Cells-Derived Exosomes (Exo-HWS + 1 vial Exo-HUVEC) Therapy
The intervention group will receive standard DM therapy plus an exosome combination of 1 vial Exo-HWS + 1 vial Exo-HUVEC, administered monthly for three months via intravenous bolus injection.
BIOLOGICALMesenchymal Stromal/Stem Cells-Derived Exosomes (Exo-HWS ) Therapy
The control group will receive standard DM therapy plus 1 vial Exo-HWS, administered monthly for three months via intravenous bolus injection.
Sponsors
Indonesia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
open-label randomized controlled trial with a pre-and-post-test control group design. The study aims to compare the effectiveness of Mesenchymal Stromal/Stem Cells-Derived Exosomes (MSC-Exos) as an additional therapy for patients with Type 2 Diabetes Mellitus (T2DM). The study will recruit 50 subjects who meet the inclusion and exclusion criteria. These subjects will be randomly assigned to one of two groups Intervention Group: This group will receive standard T2DM therapy along with a combination of exosomes, specifically 1 vial of Exo-HWS and 1 vial of Exo-HUVEC. The exosome therapy will be administered as an intravenous bolus injection monthly, for three months. Control Group: This group will receive standard T2DM therapy plus 1 vial of Exo-HWS. This therapy will also be administered monthly, for three months, via intravenous bolus injection.
Eligibility
Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients diagnosed with Type 2 Diabetes Mellitus. * Patients aged 40 to 65 years. * Patients who are willing to participate in the study and sign the informed consent form after receiving a detailed explanation of the research procedure.
Exclusion criteria
* Patients with severe comorbidities that could affect the immune response, such as autoimmune diseases, malignancies, and severe infections. * Patients currently undergoing anticoagulant therapy. * Patients currently undergoing immunosuppressive therapy. * Pregnant women, as the effects of exosome therapy on them have not been sufficiently studied. * Patients with a history of severe allergies to components of the exosome therapy. * Patients with CKD (Chronic Kidney Disease) on HD (Hemodialysis).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fasting Blood Glucose (FBG) | Baseline (Day 0) and End of the 3rd Month | Change in FBG levels from baseline to the end of the third month. Unit of Measurement: mg/dL |
| 2-Hour Postprandial Glucose | Baseline (Day 0) and End of the 3rd Month | Change in 2-hour postprandial glucose levels from baseline to the end of the third month. Unit of Measurement: mg/dL |
| HbA1c | Baseline (Day 0) and End of the 3rd Month | Change in HbA1c levels from baseline to the end of the third month. Unit of Measurement: % |
| C-peptide | Baseline (Day 0) and End of the 3rd Month | Change in C-peptide levels from baseline to the end of the third month. Unit of Measurement: ng/m |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life using DQoL | Baseline (Day 0) and End of the 3rd Month | Change in quality of life scores as measured by the Diabetes Quality of Life (DQoL) questionnaire from baseline to the end of the third month. Unit of Measurement: Score |
| CRP | Baseline (Day 0) and End of the 3rd Month | Change in C-Reactive Protein (CRP) levels from baseline to the end of the third month. Unit of Measurement: mg/L |
| IL-6 | Baseline (Day 0) and End of the 3rd Month | Change in Interleukin-6 (IL-6) levels from baseline to the end of the third month. Unit of Measurement: mg/L |
| IL-10 | Baseline (Day 0) and End of the 3rd Month | Change in Interleukin-10 (IL-10) levels from baseline to the end of the third month. Unit of Measurement: mg/L |
| D-dimer | Baseline (Day 0) and End of the 3rd Month | Change in D-dimer levels from baseline to the end of the third month. Unit of Measurement: ng/mL |
Countries
Indonesia
Contacts
Primary ContactDr. dr. Yanuar Ardani, M.Kes, Sp.PD, K-PPM, FINASIM
Outcome results
None listed