Evidence mapPaperPMID 25802471Full record

Trial reportJournal of diabetes science and technology2015

Addition of a Gastrointestinal Microbiome Modulator to Metformin Improves Metformin Tolerance and Fasting Glucose Levels.

Jeffrey H Burton, Matthew Johnson, Jolene Johnson, Daniel S Hsia, Frank L Greenway, Mark L Heiman

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

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.

0numbers the graph read from it
0cells of the map it votes in
38citing papers in PubMed
3.6field-weighted citation impact, top 7% of its field
1 · What the graph read from it

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.

2 · The registry

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.

NCT04209075 phase2completedstarted 2020, after this paper: background citation

Prebiotics and Metformin Influences Gut and Hormones in Type 2 Diabetes Youth (MIGHTY)

Ran2020Enrolled6Registered outcomes2Posted comparisons0ConditionsDiabetesArmsBiomebliss, Metformin, Placebo
Open the trial in the graph
3 · Its place in the literature

Who cites it

38 citing papers in PubMed, 76 citations in OpenAlex.

  1. Trial
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  6. Review
  7. Rethinking about Metformin: Promising Potentials.Korean journal of family medicine · 2024
    Article
  8. Biomolecular Actions by Intestinal Endotoxemia in Metabolic Syndrome.International journal of molecular sciences · 2024
    Review
  9. Article
  10. Review
  11. Article
  12. Review
  13. Review
  14. Article
  15. Review
  16. Article
  17. Imidazole Propionate is Increased in Diabetes and Associated with Stool Consistency.Diabetes, metabolic syndrome and obesity : targets and therapy · 2022
    Article
  18. Review
  19. The Hormetic Effect of Metformin: "Less Is More"?International journal of molecular sciences · 2021
    Review
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 2 institutions in 1 country.

Jeffrey H BurtonPennington Biomedical Research Center, Baton Rouge, LA, USA.
Matthew JohnsonPennington Biomedical Research Center, Baton Rouge, LA, USA Louisiana State University Health Sciences Center, Baton Rouge, LA, USA.
Jolene JohnsonLouisiana State University Health Sciences Center, Baton Rouge, LA, USA.
Daniel S HsiaPennington Biomedical Research Center, Baton Rouge, LA, USA.
Frank L GreenwayPennington Biomedical Research Center, Baton Rouge, LA, USA.
Mark L HeimanMicroBiome Therapeutics, Broomfield, CO, USA mheiman@mbiome.com.
Pennington Biomedical Research Center · USLouisiana State University Health Sciences Center New Orleans · US

Funding

Louisiana Clinical and Translational Science CenterU54GM104940 · LSU PENNINGTON BIOMEDICAL RESEARCH CTR · 2025 to 2025
$3.9M
Pilot and Feasibility ProgramP30DK072476 · LSU PENNINGTON BIOMEDICAL RESEARCH CTR · 2005 to 2025
$2.2M
PMI-5011 and Insulin ActionP50AT002776 · LSU PENNINGTON BIOMEDICAL RESEARCH CTR · 2005 to 2005
$1.5M
NCCIH NIH HHS P50 AT002776NCCIH NIH HHS P50AT002776NIDDK NIH HHS 2P30DK072476NIDDK NIH HHS P30 DK072476NIDDK NIH HHS T35 DK093428NIGMS NIH HHS 1 U54 GM104940NIGMS NIH HHS U54 GM104940
6 · The paper itself

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.

Indexed as

FastingFood, FormulatedAdultAgedbeta-GlucansBlood GlucoseBody Mass IndexCross-Over StudiesDiabetes Mellitus, Type 2FemaleGastrointestinal MicrobiomeGlucose Tolerance TestHumansHypoglycemic AgentsInulinMalebeta-GlucansBlood GlucoseHypoglycemic AgentsInulinMetforminPlant ExtractsPolyphenolsGI adverse eventsglucosemetforminmetformin intolerancemicrobiome modulatorNM504

Identifiers

PMID25802471
PMCPMC4525649
OpenAlexW2171312946

What Socratic holds

Texttitle and abstract
Read underepoch 390

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.