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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04113239
Other study ID # T2D+FFQ/GPAQ/Genome/Metagenome
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 27, 2019
Est. completion date November 25, 2021

Study information

Verified date February 2021
Source Atlas Biomed
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

A case-control study to identify microbiome and genetic differences between healthy people and patients with incident type 2 diabetes mellitus.


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.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date November 25, 2021
Est. primary completion date October 20, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Russian Federation City Clinical Hospital V.P. Demikhova Moscow

Sponsors (1)

Lead Sponsor Collaborator
Atlas Biomed

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type Measure Description Time frame Safety issue
Primary HbA1C Glycated hemoglobin level Baseline
Primary Glucose Fasting blood glucose level Baseline
Primary Gut microbiome composition of participants Bacteria abundance obtained via sequencing the DNA extracted from the stool sample Baseline
Primary Genotypes of participants Genotypes of thousands of SNPs obtained via DNA-microarray genotyping of the DNA extracted from the saliva sample Baseline
Secondary 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
Secondary Food frequency questionnaire 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
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