Study of the Genome, Gut Metagenome and Lifestyle of Patients With Incident Type 2 Diabetes Mellitus
1 other identifier
observational
200
1 country
1
Brief Summary
A case-control study to identify microbiome and genetic differences between healthy people and patients with incident type 2 diabetes mellitus.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 1, 2019
CompletedFirst Posted
Study publicly available on registry
October 2, 2019
CompletedStudy Start
First participant enrolled
November 27, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 20, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 25, 2021
CompletedJuly 20, 2022
February 1, 2021
1.9 years
October 1, 2019
July 19, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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 Outcomes (2)
Physical activity questionnaire
Baseline
Food frequency questionnaire
12 months before baseline
Study Arms (2)
Diagnosed Type 2 Diabetes Mellitus
Patients with incident type 2 diabetes mellitus
Control
Volunteers without diagnosed type 2 diabetes mellitus and who don't meet the exclusion criteria
Interventions
Taking a stool sample for gut microbiome DNA sequencing
Taking a saliva sample for genotyping
Eligibility Criteria
Healthy volunteers and patients with incident type 2 diabetes mellitus from Russia, Moscow
You may qualify if:
- Confirmed diagnosis of incident type 2 diabetes mellitus
You may not qualify if:
- 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Atlas Biomedlead
Study Sites (1)
City Clinical Hospital V.P. Demikhova
Moscow, Russia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 1, 2019
First Posted
October 2, 2019
Study Start
November 27, 2019
Primary Completion
October 20, 2021
Study Completion
November 25, 2021
Last Updated
July 20, 2022
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will not share