Effect of probiotics on insulin resistance and oxidative stress markers in diabetic patients with end-stage renal disease on hemodialysis
- Conditions
- Health Condition 1: E112- Type 2 diabetes mellitus with kidney complications
- Registration Number
- CTRI/2021/11/038044
- Lead Sponsor
- Imran Khan
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
2.Patients who are type 2 diabetic for at least 5 years and on stable diabetic medication at least for a period of 3 months prior to start of study
3.Patients with HbA1c value in the range of 7 to 10 %
4.Patients with an HOMA-IR value > 4
5.End Stage Renal disease patients who are undergoing hemodialysis thrice weekly at least for a period of 3 months prior to start of study
6.Patients willing to treatment regimens and follow the study procedure
1.Pregnant and lactating women
2.Patients with active gastrointestinal diseases (Inflammatory bowel disease, irritable bowel syndrome)
3.Patients who are taking or have taken probiotics or probiotics within last month prior to start of study
4.Patients who are taking antioxidants and/or anti-inflammatory supplements (Vitamin E, Vitamin C, or omega-3 fatty acids)
5.Patients who are taking immunosuppressive medication within 3 months before enrolment in the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in HOMA-IR (Homeostasis Model of Assessment-estimated insulin resistance) and Oxidative stress markers (Nitric Oxide, Malondialdehyde, Glutathione)Timepoint: Baseline to 12 weeks
- Secondary Outcome Measures
Name Time Method Change in glycemic parameters (Fasting Plasma Sugar, Glycosylated Hemoglobin) <br/ ><br>Change in Lipid Profile (Triglycerides, Total Cholesterol, High Density Lipoprotein, Low Density Lipoprotein) <br/ ><br>Incidence of adverse eventsTimepoint: Baseline to 12 weeks