Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Probiotic enriched Prebiotic supplement: Duration of the supplement: 15 weeks. Developed product needed to be consumed by study participants for the entire study duration of 15 weeks wi
Sponsors
Sri Ramachandra Institute of Higher Education and Research NPV Ramaswamy Udayar Fellowship
Eligibility
Inclusion criteria
Inclusion criteria: Subjects will be included based on the following criteria: The study participants include people above 18 years with uncontrolled Type 2 diabetes has HbA1c (10-14%), and CBG (250-400mg/dl). Willing to participate in the study, who are getting treatment at Sri Ramachandra Medical Centre and SRH.
Exclusion criteria
Exclusion criteria: To exclude gestational and other diabetes types (maturity-onset diabetes of the young (MODY), type 1 diabetes, and Latent Autoimmune Diabetes in Adults (LADA). To exclude subjects with any chronic illness and immunocompromised state (Chronic Kidney Disease, Chronic Liver Disease, oncological condition, and AIDS). People who are allergic to the prescribed product. On antibiotic supplements and steroid treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| OUTCOME PARAMETERS: HbA1c, CBG, FBS, PPBS- Baseline, midline, and endline supplementation. HOMA IR- Baseline, midline, and endline supplementation. C-REACTIVE PROTEIN- Baseline, midline, and endline supplementation.Timepoint: Baseline (0 week): HbA1c, CBG, FBS, PPBS, HOMA IR, C-REACTIVE PROTEIN Midline (8th week): CBG, FBS, PPBS, HOMA IR, C-REACTIVE PROTEIN Endline (15th week): CBG, FBS, PPBS, HOMA IR, C-REACTIVE PROTEIN | — |
Secondary
| Measure | Time frame |
|---|---|
| Fecal DNA extraction: The gut microbiota is commonly measured through the fecal DNA extraction method. The fecal DNA extraction method will be measured to the randomly selected group after supplementation. Fecal sample collection After 15 weeks of supplementation, the fecal samples of randomly selected 5 individuals from each experimental & control group will be collected for DNA extraction experiments. The fecal samples will be collected within 3-4 hours in sterile containers, will be promptly transported to the laboratory, & stored at a suitable temperature until DNA extraction for further analysis. Timepoint: Endline 15th week | — |
Countries
India
Contacts
Public ContactDr N Preetha
Sri Ramachandra Institute of Higher Education and Research
Outcome results
None listed