A prospective, parallel group, interventional and open label study to evaluate the effect of probiotics on glycemic control in prediabetic patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Primary objective is to compare the levels of Fasting Plasma Glucose (FPG), Post Prandial Plasma Glucose (2h PG) and HbA1c in prediabetic patients on probiotic along with dietary control versus those on dietary control only.
Study Overview
Brief Summary
Prediabetes is a state ofhyperglycemia with blood sugar levels below the cut-off levels for diabetes. Genetic, environmental, and metabolicrisk factors contribute to the development of type 2 diabetes mellitus and an importantrole of nutritional factors and gut microbiota has been shown in thedevelopment of diabetes. Some of the recent studies indicate that changes ingut microbiota can promote insulin resistance and lead to diabetes. Understandingthe involvement of gut microbiome in Diabetes Mellitus is a relatively newfield and requires further research. Also, probiotics have been shown toimprove or alter the gut microbiome as a useful intervention in variouspathological states. The present study aims to evaluate the effect ofprobiotics on glycemic control in prediabetic patients. It will be prospective,parallel group, interventional and open label study of 90 days. It willcomprise 70 prediabetic patients of either sex above the age of 18 years fromthe OPD of Department of Medicine, Guru Nanak Dev Hospital attached toGovernment Medical College, Amritsar. Patients will be randomly divided intotwo groups – A and B of 35 patients each. Group A will be prescribed 1 capsule(2.5 billion CFU) of probiotic OD along with diet control. Group B will be puton diet control only. Follow up will be done at day 42 and day 90. Patientswill undergo assessment of Fasting plasma glucose, Post prandial plasmaglucose, HbA1c, Total lipid profile and any adverse effects during the courseof the study. Data will be compiled, tabulated and analyzed statistically.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Open Label
Eligibility Criteria
- Ages
- 18.00 Year(s) to 80.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Inclusion criteria:
- •Prediabetic patients visiting the Medicine Out Patient Department.
- •Both male and female patients of age more than 18 years.
- •Patients willing to join the study after giving the informed consent.
Exclusion Criteria
- •Exclusion criteria:
- •Patient not willing to provide a written consent for the study.
- •Patients who are currently on any lipid lowering agents.
- •Pregnant and lactating females.
- •Seriously and chronically ill patients.
- •Conditions of Inflammatory Bowel Disease and malabsorption.
Outcomes
Primary Outcomes
Primary objective is to compare the levels of Fasting Plasma Glucose (FPG), Post Prandial Plasma Glucose (2h PG) and HbA1c in prediabetic patients on probiotic along with dietary control versus those on dietary control only.
Time Frame: Day 0 | Day 42 | Day 90
Secondary Outcomes
- Secondary objective is to assess the effect of probiotic on Body Weight, BMI, Total serum cholesterol, LDL cholesterol, HDL cholesterol, & Triglycerides of prediabetic patients with dyslipidemia recruited in the study.(Day 0)