Study of the Genome, Gut Metagenome and Lifestyle of Patients With Incident Type 2 Diabetes Mellitus

Atlas Biomed

Status: Completed

Conditions: Genetic Predisposition; Diabetes Mellitus, Type 2; Metagenome

Treatments: Diagnostic Test: 16S rRNA gene sequencing; Genetic: DNA-microarray genotyping

Study type: Observational

Funder types: Industry

Identifiers

NCT04113239

T2D+FFQ/GPAQ/Genome/Metagenome

Details and patient eligibility

About

A case-control study to identify microbiome and genetic differences between healthy people and patients with incident type 2 diabetes mellitus.

Full description

Two groups of people, one composed of healthy volunteers and the other of patients with incident type 2 diabetes mellitus who never received treatment for their condition, fill in the food frequency questionnaire and the physical activity questionnaire. DNA microarray genotyping is used to process the DNA samples of the participants. The data on the composition of the participants' gut microbiota is obtained through sequencing of their stool samples.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Confirmed diagnosis of incident type 2 diabetes mellitus

Exclusion criteria

• Hypoglycaemic therapy prescribed for the correction of any type of hyperglycaemia
• Diabetic ketoacidosis
• Inflammatory bowel diseases (ulcerative colitis, Crohn's disease, coeliac disease)
• Rheumatoid arthritis
• Tuberculosis
• Acute gastrointestinal conditions
• Irritable bowel syndrome
• Multiple intestinal polyposis
• Gallstone disease
• Acute pancreatitis
• Oncological diseases
• Serious mental disorders
• Recent (< 6 months) antimicrobial therapy
• Recent (< 3 months) proton pump inhibitors therapy
• Recent (< 3 months) surgical intervention
• Recent (< 3 weeks) use of probiotics, prebiotics, antacids, nonsteroidal anti-inflammatory drugs
• Pregnancy or breastfeeding
• Current alcohol/drug abuse or addiction within 12 months prior to screening
• Planned relocation from the study area during the study
• Other somatic pathologies or any factors that prevent the inclusion in the study

Trial design

200 participants in 2 patient groups

Diagnosed Type 2 Diabetes Mellitus

Description:

Patients with incident type 2 diabetes mellitus

Treatment:

Genetic: DNA-microarray genotyping

Diagnostic Test: 16S rRNA gene sequencing

Control

Description:

Volunteers without diagnosed type 2 diabetes mellitus and who don't meet the exclusion criteria

Treatment:

Genetic: DNA-microarray genotyping

Diagnostic Test: 16S rRNA gene sequencing