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

Atlas Biomed200 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Diabetes Mellitus, Type 2 Metagenome Genetic Predisposition

Interventions

16S rRNA gene sequencingDIAGNOSTIC_TEST

Taking a stool sample for gut microbiome DNA sequencing

DNA-microarray genotypingGENETIC

Taking a saliva sample for genotyping

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

City Clinical Hospital V.P. Demikhova

Moscow, Russia

Outcomes

Primary Outcomes

HbA1C

Glycated hemoglobin level

Time frame: Baseline

Glucose

Fasting blood glucose level

Time frame: Baseline

Gut microbiome composition of participants

Bacteria abundance obtained via sequencing the DNA extracted from the stool sample

Time frame: Baseline

Genotypes of participants

Genotypes of thousands of SNPs obtained via DNA-microarray genotyping of the DNA extracted from the saliva sample

Time frame: Baseline

Secondary Outcomes

Physical activity questionnaire

Physical Activity Questionnaire. It collects information on physical activity comprising 16 questions grouped in four domains: activity at work (1), travel to and from places (2), recreational activities (3), sedentary behaviour (4).

Time frame: Baseline

Food frequency questionnaire

Food frequency questionnaire assesses usual intake and portion size of more than 130 foods and beverages and more than 25 dietary supplements for the last 12 months. Responses are evaluated and analysed to compile a nutritional picture for each group of subjects.

Time frame: 12 months before baseline

Data from ClinicalTrials.gov

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