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The Interaction Between Metformin and Microbiota - the MEMO Study.

NCT ID: NCT03718715

Last Updated: 2020-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-20

Study Completion Date

2022-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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prospective cohort

All participants receive Metformin in accordance to the ordinary therapy practice. They will be part of one subject group/cohort. After onset of metformin treatment the subjects who develop gastrointestinal side effects will be compared with cases without gastrointestinal side effects.

Metformin

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Type 2 diabetes (diagnosis set within the last 12 months)
* planned metformin treatment
* Age: 40 - 80 years
* Have provided written informed consent.

Exclusion Criteria

* already started treatment with Metformin
* intestinal disease incl. irritable bowel syndrome
* treatment with antibiotics in the last 3 months
* Inflammatory disorder t.ex. rheumatoid arthritis
* anemia, haemoglobinopathy
* alcohol or drug abuse
* cancer disease under treatment
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Göteborg University

OTHER

Sponsor Role collaborator

Örebro University, Sweden

OTHER

Sponsor Role collaborator

Linkoeping University

OTHER_GOV

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role collaborator

Umeå University

OTHER

Sponsor Role lead

Responsible Party

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Olov Rolandsson

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Olov Rolandsson, Professor

Role: PRINCIPAL_INVESTIGATOR

Umeå University

Locations

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Region Västerbotten

Umeå, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Olov Rolandsson, Professor

Role: CONTACT

[email protected]
+46 90 786 50 00

Facility Contacts

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Kenny Kalin, MD

Role: primary

[email protected]
070-7991186

Other Identifiers

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MEMO

Identifier Type: -

Identifier Source: org_study_id