Trial reportJournal of diabetes science and technology2015
Addition of a Gastrointestinal Microbiome Modulator to Metformin Improves Metformin Tolerance and Fasting Glucose Levels.
Trial report in Journal of diabetes science and technology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04209075 (Prebiotics and Metformin Influences Gut and Hormones in Type 2 Diabetes Youth), which is not on this map. Cited by 38 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Prebiotics and Metformin Influences Gut and Hormones in Type 2 Diabetes Youth (MIGHTY)
Open the trial in the graphWho cites it
38 citing papers in PubMed, 76 citations in OpenAlex.
- Combining a diet rich in fermentable carbohydrates with metformin improves glycaemic control and reshapes the gut microbiota in people with prediabetes.Nature metabolism · 2025Trial
- The effects of prebiotics on gastrointestinal side effects of metformin in youth: A pilot randomized control trial in youth-onset type 2 diabetes.Frontiers in endocrinology · 2023Trial
- Metformin with Versus without Concomitant Probiotic Therapy in Newly Diagnosed Patients with Type 2 Diabetes or Prediabetes: A Comparative Analysis in Relation to Glycemic Control, Gastrointestinal Side Effects, and Treatment Compliance.The Turkish journal of gastroenterology : the official journal of Turkish Society of Gastroenterology · 2022Trial
- Trial
- Association of metformin administration with gut microbiome dysbiosis in healthy volunteers.PloS one · 2018Trial
- A Systematic Review of Gut Microbiota Diversity: A Key Player in the Management and Prevention of Diabetes Mellitus.Cureus · 2024Review
- Rethinking about Metformin: Promising Potentials.Korean journal of family medicine · 2024Article
- Biomolecular Actions by Intestinal Endotoxemia in Metabolic Syndrome.International journal of molecular sciences · 2024Review
- Apoptotic and proliferative processes in the small intestine of rats with type 2 diabetes mellitus after metformin and propionic acid treatment.Frontiers in pharmacology · 2024Article
- Advancements in precision medicine: multi-omics approach for tailored metformin treatment in type 2 diabetes.Frontiers in pharmacology · 2024Review
- Microbiome differences related to metformin intolerance among Black individuals with diabetes, a pilot cross-sectional study.Metabolism open · 2023Article
- Inflammatory Bowel Sugar Disease: A Pause From New Pharmacological Agents and an Embrace of Natural Therapy.Cureus · 2023Review
- Short-Chain Fatty Acids as Bacterial Enterocytes and Therapeutic Target in Diabetes Mellitus Type 2.Biomedicines · 2022Review
- Microbiome, Mycobiome and Related Metabolites Alterations in Patients with Metabolic Syndrome-A Pilot Study.Metabolites · 2022Article
- Effects of Oral Glucose-Lowering Agents on Gut Microbiota and Microbial Metabolites.Frontiers in endocrinology · 2022Review
- Polyethylene Glycol Loxenatide Injection (GLP-1) Protects Vascular Endothelial Cell Function in Middle-Aged and Elderly Patients With Type 2 Diabetes by Regulating Gut Microbiota.Frontiers in molecular biosciences · 2022Article
- Imidazole Propionate is Increased in Diabetes and Associated with Stool Consistency.Diabetes, metabolic syndrome and obesity : targets and therapy · 2022Article
- Pharmacomicrobiomics in Western Medicine and Traditional Chinese Medicine in Type 2 Diabetes.Frontiers in endocrinology · 2022Review
- The Hormetic Effect of Metformin: "Less Is More"?International journal of molecular sciences · 2021Review
- Metformin treatment and gastrointestinal symptoms in youth: Findings from a large tertiary care referral center.Pediatric diabetes · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 2 institutions in 1 country.
Funding
Abstract
backgroundAdverse effects of metformin are primarily related to gastrointestinal (GI) intolerance that could limit titration to an efficacious dose or cause discontinuation of the medication. Because some metformin side effects may be attributable to shifts in the GI microbiome, we tested whether a GI microbiome modulator (GIMM) used in combination with metformin would ameliorate the GI symptoms.
methodsA 2-period crossover study design was used with 2 treatment sequences, either placebo in period 1 followed by GIMM in period 2 or vice versa. Study periods lasted for 2 weeks, with a 2-week washout period between. During the first week, type 2 diabetes patients (T2D) who experienced metformin GI intolerance took 500 mg metformin along with their assigned NM504 (GIMM) or placebo treatment with breakfast and with dinner. In the second week, the 10 subjects took 500 mg metformin (t.i.d.), with GIMM or placebo consumed with the first and third daily metformin doses. Subjects were permitted to discontinue metformin dosing if it became intolerable.
resultsThe combination of metformin and GIMM treatment produced a significantly better tolerance score to metformin than the placebo combination (6.78 ± 0.65 [mean ± SEM] versus 4.45 ± 0.69, P = .0006). Mean fasting glucose levels were significantly (P < .02) lower with the metformin-GIMM combination (121.3 ± 7.8 mg/dl) than with metformin-placebo (151.9 ± 7.8 mg/dl).
conclusionCombining a GI microbiome modulator with metformin might allow the greater use of metformin in T2D patients and improve treatment of the disease.
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What Socratic holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.