Study of the Genome, Gut Metagenome and Lifestyle of Patients With Incident Type 2 Diabetes Mellitus
Study Details
Study Description
Brief Summary
A case-control study to identify microbiome and genetic differences between healthy people and patients with incident type 2 diabetes mellitus.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Diagnosed Type 2 Diabetes Mellitus Patients with incident type 2 diabetes mellitus |
Diagnostic Test: 16S rRNA gene sequencing
Taking a stool sample for gut microbiome DNA sequencing
Genetic: DNA-microarray genotyping
Taking a saliva sample for genotyping
|
| Control Volunteers without diagnosed type 2 diabetes mellitus and who don't meet the exclusion criteria |
Diagnostic Test: 16S rRNA gene sequencing
Taking a stool sample for gut microbiome DNA sequencing
Genetic: DNA-microarray genotyping
Taking a saliva sample for genotyping
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | City Clinical Hospital V.P. Demikhova | Moscow | Russian Federation |
Sponsors and Collaborators
- Atlas Biomed
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- T2D+FFQ/GPAQ/Genome/Metagenome