Diabetes Mellitus, Type 2, Genetic Predisposition, Metagenome
Conditions
Keywords
Gut Metagenetics, Diabetes Mellitus, Type 2, Genetics, Microbiome, FFQ, GPAQ
Brief summary
A case-control study to identify microbiome and genetic differences between healthy people and patients with incident type 2 diabetes mellitus.
Detailed 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.
Interventions
DIAGNOSTIC_TEST16S rRNA gene sequencing
Taking a stool sample for gut microbiome DNA sequencing
GENETICDNA-microarray genotyping
Taking a saliva sample for genotyping
Sponsors
Atlas Biomed
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1C | Baseline | Glycated hemoglobin level |
| Glucose | Baseline | Fasting blood glucose level |
| Gut microbiome composition of participants | Baseline | Bacteria abundance obtained via sequencing the DNA extracted from the stool sample |
| Genotypes of participants | Baseline | Genotypes of thousands of SNPs obtained via DNA-microarray genotyping of the DNA extracted from the saliva sample |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physical activity questionnaire | Baseline | 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). |
| Food frequency questionnaire | 12 months before baseline | 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. |
Countries
Russia
Outcome results
None listed