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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnosed Type 2 Diabetes Mellitus | Patients with incident type 2 diabetes mellitus |
| |
| Control | Volunteers without diagnosed type 2 diabetes mellitus and who don't meet the exclusion criteria |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 16S rRNA gene sequencing | Diagnostic Test | Taking a stool sample for gut microbiome DNA sequencing |
|
| Measure | Description | Time Frame |
|---|---|---|
| HbA1C | Glycated hemoglobin level | Baseline |
| Glucose | Fasting blood glucose level | Baseline |
| Gut microbiome composition of participants | Bacteria abundance obtained via sequencing the DNA extracted from the stool sample | Baseline |
| Genotypes of participants | Genotypes of thousands of SNPs obtained via DNA-microarray genotyping of the DNA extracted from the saliva sample | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline |
| Food frequency questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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Healthy volunteers and patients with incident type 2 diabetes mellitus from Russia, Moscow
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City Clinical Hospital V.P. Demikhova | Moscow | Russia |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D020022 | Genetic Predisposition to Disease |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| DNA-microarray genotyping | Genetic | Taking a saliva sample for genotyping |
|
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. |
| 12 months before baseline |
| D004700 | Endocrine System Diseases |
| D004198 | Disease Susceptibility |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |