The Interaction Between Metformin and Microbiota - the MEMO Study.

Umeå University

Status: Unknown

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Metformin

Study type: Observational

Funder types: Other

Identifiers

NCT03718715

MEMO

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

600 participants in 1 patient group

prospective cohort

Description:

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.

Treatment:

Drug: Metformin