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The Interaction Between Metformin and Microbiota - the MEMO Study.

NCT03718715 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 600

Last updated 2020-11-04

No results posted yet for this study

Summary

Metformin has been used in Sweden since 1957, and it is recommended as first line therapy for type 2-diabetes (T2D) in national and international guidelines. However, adverse effects involving diarrhea, constipation, bloating, and abdominal pain are common which leads to discontinuation of medication or not being able to reach therapeutic doses. Here the investigators will perform a prospective study to investigate whether i) participants with T2D who experience adverse events following metformin treatment have an altered microbiota at baseline compared to participants without adverse events and ii) if the microbiota is altered in participants during onset of adverse events. The investigators hypothesis is that adverse effects associated with metformin are caused by an altered gut microbiota, either at base line or following metformin treatment. The study design is a nested case-cohort study. The investigators will recruit 600 patients and expect 200 individuals to have side effects and 400 without during a 24-month study period. Fecal samples will be collected at baseline, 2 months, and 4 months or when gastrointestinal symptoms occur. All fecal samples will be sequenced by 16s rRNA (ribosomal ribonucleic acid) sequencing to obtain a baseline microbiota profile; a subpopulation consisting of homogenous groups of participants will be in depth-analyzed using shotgun sequencing. If the hypothesis is confirmed this project may lead to bacterial therapies that will allow more patients tolerate metformin.

Conditions

Interventions

DRUG

Metformin

Receiving Metformin is no study intervention. The investigators have no influence on the Metformin treatment. All participants receive Metformin provided by the health care system. The individual case determine dose and frequency of the treatment as part of the usual therapy guidelines.

Sponsors & Collaborators

  • Göteborg University

    collaborator OTHER

  • Örebro University, Sweden

    collaborator OTHER

  • Linkoeping University

    collaborator OTHER_GOV

  • Karolinska Institutet

    collaborator OTHER

  • Umeå University

    lead OTHER

Principal Investigators

  • Olov Rolandsson, Professor · Umeå University

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-20
Primary Completion
2021-12-31
Completion
2022-03-31

Countries

  • Sweden

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03718715 on ClinicalTrials.gov