Study of the Genome, Gut Metagenome and Lifestyle of Patients With Incident Type 2 Diabetes Mellitus
NCT ID: NCT04113239
Last Updated: 2022-07-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
200 participants
OBSERVATIONAL
2019-11-27
2021-11-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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Diagnosed Type 2 Diabetes Mellitus
Patients with incident type 2 diabetes mellitus
16S rRNA gene sequencing
Taking a stool sample for gut microbiome DNA sequencing
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
16S rRNA gene sequencing
Taking a stool sample for gut microbiome DNA sequencing
DNA-microarray genotyping
Taking a saliva sample for genotyping
Interventions
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16S rRNA gene sequencing
Taking a stool sample for gut microbiome DNA sequencing
DNA-microarray genotyping
Taking a saliva sample for genotyping
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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Atlas Biomed
INDUSTRY
Responsible Party
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Locations
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City Clinical Hospital V.P. Demikhova
Moscow, , Russia
Countries
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Other Identifiers
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T2D+FFQ/GPAQ/Genome/Metagenome
Identifier Type: -
Identifier Source: org_study_id
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