Enhancing the Efficacy and Tolerability of Metformin by add-on Polyherbal Formulation: a Gut Microbiome Study

Launched by PAULS STRADINS CLINICAL UNIVERSITY HOSPITAL · Feb 20, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at how a combination of a traditional herbal remedy and metformin, a common medication for managing Type 2 diabetes, affects the gut bacteria of patients. The study aims to understand if this herbal addition can improve the effectiveness of metformin and help patients better manage their diabetes. The trial will involve 66 participants, and it will take place from June 2024 to December 2026.

To be eligible for the study, participants must be between 25 and 80 years old, have a confirmed diagnosis of Type 2 diabetes with specific blood sugar levels, and have experienced issues with metformin in the past, such as stomach problems. Participants will need to agree to provide stool samples and wear a device to monitor their blood sugar continuously. Please note that certain conditions, like Type 1 diabetes or severe complications from diabetes, will exclude individuals from participating. This study has not yet started recruiting participants, but it offers an opportunity to explore new ways to improve diabetes management.

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Eligibility criteria

• Inclusion Criteria:
• Participants must meet all of the following criteria to be eligible for enrollment:
• • Clinical diagnosis of Type 2 Diabetes Mellitus (T2D) HbA1c level between 6.5% and 8.5% On a stable dose of oral antidiabetic therapy for at least 6 months Age: ≥ 25 years and ≤ 80 years History of metformin intolerance, defined as previously reported gastrointestinal side effects or inability to tolerate full-dose metformin Willing and able to provide written informed consent Willing to comply with study procedures, including stool sample collection and continuous glucose monitoring (CGM)
• Exclusion Criteria:
• Participants will be excluded if they meet any of the following criteria:
• • Type 1 Diabetes Mellitus Current or recent (last 6 months) use of polyherbal formulations (PHF) Pregnancy or breastfeeding
• Severe diabetic complications, such as:
• • Diabetic ketoacidosis Proliferative retinopathy Chronic kidney disease Stage IIIb or higher (eGFR \<45 mL/min/1.73m²)
• Recent cardiovascular events (within the last 6 months), including:
• • Stroke Myocardial infarction Unstable angina Heart failure
• Severe systemic disease that could interfere with participation, such as:
• • Active cancer Severe autoimmune disease Current antibiotic therapy (within 2 months of study enrollment) Use of probiotics or prebiotics (within 1 month of study enrollment)
• Severe gastrointestinal conditions, including:
• • Inflammatory bowel disease Chronic diarrhea of unknown origin Severe infection requiring antibacterial therapy Participation in another interventional study within the last 3 months