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

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

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2; Genetic Predisposition; Metagenome
• Intervention / Treatment: Diagnostic test: 16S rRNA gene sequencing; Genetic: DNA-microarray genotyping

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 Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation
    • City Clinical Hospital V.P. Demikhova

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers and patients with incident type 2 diabetes mellitus from Russia, Moscow

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1C	Glycated hemoglobin level	Baseline
Glucose	Fasting blood glucose level	Baseline
Gut microbiome composition of participants	Bacteria abundance obtained via sequencing the DNA extracted from the stool sample	Baseline
Genotypes of participants	Genotypes of thousands of SNPs obtained via DNA-microarray genotyping of the DNA extracted from the saliva sample	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Atlas Biomed

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2019
• Primary Completion (Actual): October 20, 2021
• Study Completion (Actual): November 25, 2021

Study Registration Dates

• First Submitted: October 1, 2019
• First Submitted That Met QC Criteria: October 1, 2019
• First Posted (Actual): October 2, 2019

Study Record Updates

• Last Update Posted (Actual): July 20, 2022
• Last Update Submitted That Met QC Criteria: July 19, 2022
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Genetics; Microbiome; Diabetes Mellitus, Type 2; Gut Metagenetics; FFQ; GPAQ
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Disease Attributes; Diabetes Mellitus; Diabetes Mellitus, Type 2; Disease Susceptibility; Genetic Predisposition to Disease
• Other Study ID Numbers: T2D+FFQ/GPAQ/Genome/Metagenome

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No