Study of the Genome, Gut Metagenome and Lifestyle of Patients With Incident Type 2 Diabetes Mellitus

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Study of the Genome, Gut Metagenome and Lifestyle of Patients With Incident Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04113239
• Other study ID #: T2D+FFQ/GPAQ/Genome/Metagenome
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Disease Susceptibility
• Genetic Predisposition
• Genetic Predisposition to Disease
• Metagenome

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