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

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-27

Study Completion Date

2021-11-25

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Diabetes Mellitus, Type 2 Metagenome Genetic Predisposition

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Diagnosed Type 2 Diabetes Mellitus

Patients with incident type 2 diabetes mellitus

16S rRNA gene sequencing

Intervention Type DIAGNOSTIC_TEST

Taking a stool sample for gut microbiome DNA sequencing

DNA-microarray genotyping

Intervention Type GENETIC

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

Intervention Type DIAGNOSTIC_TEST

Taking a stool sample for gut microbiome DNA sequencing

DNA-microarray genotyping

Intervention Type GENETIC

Taking a saliva sample for genotyping

Interventions

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16S rRNA gene sequencing

Taking a stool sample for gut microbiome DNA sequencing

Intervention Type DIAGNOSTIC_TEST

DNA-microarray genotyping

Taking a saliva sample for genotyping

Intervention Type GENETIC

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Atlas Biomed

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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City Clinical Hospital V.P. Demikhova

Moscow, , Russia

Site Status

Countries

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Russia

Other Identifiers

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T2D+FFQ/GPAQ/Genome/Metagenome

Identifier Type: -

Identifier Source: org_study_id

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