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

Обзор

Study population: Type 2 diabetes patients Design of the study: Randomized, two-arm, placebo-controlled, and prospective crossover cohort study. Objective: To evaluate the effects of interactions between metformin and traditionally used polyherbal formulations on gut microbiota in a prospective crossover study involving type 2 diabetes mellitus patients. Sample size: 66 patients. Duration of study: 06/2024 - 12/2026

Вмешательства

• Пищевая добавка Polyherbal Formulation (PHF)
  Description: A polyherbal formulation with known beneficial effects on gut microbiota and metabolic regulation. The formulation contains selected plant extracts studied for their hypoglycemic, antioxidant, and gut microbiota-modulating properties. Administration: Oral, daily dosage as per study protocol. Supplier: Arya Vaidya Pharmacy (AVP), Coimbatore, India (GMP-certified).
• Другое Placebo
  Type: Placebo Comparator Description: A placebo formulation that matches PHF in appearance, texture, and administration schedule. Administration: Oral, daily dosage as per study protocol.
• Препарат Metformin (Standard Treatment for Type 2 Diabetes)
  Description: Metformin is an FDA and EMA-approved antihyperglycemic medication that improves glycemic control by reducing hepatic glucose production and enhancing insulin sensitivity. Administration: Oral, per standard dosing guidelines. Availability: Provided to all participants per the national reimbursement scheme for T2D patients in Latvia.

Первичные конечные точки

• Change in Glycemic Control (HbA1c Levels) [Срок оценки: Baseline, Week 24, Week 48]

Вторичные конечные точки (8)

• Relative Abundance of Key Bacterial Taxa in Gut Microbiota [Срок оценки: Baseline, Week 2, Week 24, Week 25, Week 48]
• Gastrointestinal Tolerability of Metformin [Срок оценки: Baseline, Week 2, Week 24, Week 25, Week 48]
• Fasting and Postprandial Blood Glucose Levels [Срок оценки: Baseline, Week 24, Week 48]
• Time in Range (TIR) Measured by Continuous Glucose Monitoring (CGM) [Срок оценки: Week 1]
• Metabolomic Analysis of Stool Samples (Short-chain fatty acids (SCFAs)) [Срок оценки: Baseline, Week 24, Week 48]
• Patient-Reported Outcomes on Quality of Life [Срок оценки: Baseline, Week 24, Week 48]
• Metabolomic Analysis of Stool Samples (Amino acids) [Срок оценки: Baseline, Week 24, Week 48]
• Metabolomic Analysis of Stool Samples (Bile acids) [Срок оценки: Baseline, Week 24, Week 48]

Критерии участия

Критерии включения

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)

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Латвия · 1 центр

• Pauls Stradins Clinical University Hospital — Riga

Идентификаторы

NCT: NCT06846138 · lzp-2023/1-0422 · lzp-2023/1-0422

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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