EXPLORING THE THERAPEUTIC POTENTIAL OF PROBIOTICS IN MODULATING GLYCEMIC LEVELS IN TYPE 2 DIABETES MELLITUS
Overview
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Self
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Improved Glycemic Control: A significant reduction in HbA1c, fasting blood glucose (FBG), Postbrandial blood gulcose, HOMA-IR levels
Overview
Brief Summary
Our study is a prospective interventional trial conducted over six months to evaluate the therapeutic potential of probiotics in modulating glycemic control and inflammatory status in Type 2 Diabetes Mellitus (T2DM) patients diagnosed within the last two years. A total of 50 participants with moderate glycemic control will be enrolled and divided into two groups: 25 receiving probiotics daily for 12 weeks and 25 serving as controls. The study aims to measure changes in fasting blood glucose (FBG), postprandial blood glucose (PBG), HbA1c, HOMA IR and hsCRP before and after intervention. The expected outcome is a significant reduction in glycemic markers and hsCRP in the probiotic group compared to controls, highlighting probiotics as a potential adjunct therapy in T2DM management.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 30.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •* Patients above 30 and below 65 years. * Patients diagnosed with Type 2 Diabetes Mellitus within 2years * HbA1C range between 6.5%.
- •9.0% (Moderate glycemic control) * hs.
- •CRP with the range 1.0 – 10.0 mg/dL * No major changes in treatment for X 3 months. * Patients who agree to participate by knowing the objectives of the study and voluntarily participate.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Improved Glycemic Control: A significant reduction in HbA1c, fasting blood glucose (FBG), Postbrandial blood gulcose, HOMA-IR levels
Time Frame: 6 months
in the probiotic group compared to the control group.
Time Frame: 6 months
Reduction in hsCRP Levels: A notable decrease in high-sensitivity C-reactive protein (hsCRP), indicating
Time Frame: 6 months
reduced systemic inflammation, which is linked to better glycemic control
Time Frame: 6 months
Secondary Outcomes
No secondary outcomes reported
Investigators
Dr P Dhivyaprasath
Swamy Vivekanandha College of Pharmacy