Diabetes Mellitus, Type 2NCT04113239
Study of the Genome, Gut Metagenome and Lifestyle of Patients With Incident Type 2 Diabetes Mellitus
An observational study of Diabetes Mellitus, Type 2 and Metagenome, run by Atlas Biomed at 1 site in Russia.
Trial summary
A case-control study to identify microbiome and genetic differences between healthy people and patients with incident type 2 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2, Metagenome, Genetic Predisposition
- What is being tested?
- 16S rRNA gene sequencing and DNA-microarray genotyping
- How many people
- 200 participants
- Where
- 1 siteRussia
- Study dates
- 27 Nov 2019to 25 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers and patients with incident type 2 diabetes mellitus from Russia, Moscow
Who may be able to join
- Confirmed diagnosis of incident type 2 diabetes mellitus
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
A case-control study to identify microbiome and genetic differences between healthy people and patients with incident type 2 diabetes mellitus.
Read the 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.
- Being tested
- 16S rRNA gene sequencing, DNA-microarray genotyping
- Keywords
- Gut Metagenetics, Diabetes Mellitus, Type 2, Genetics, Microbiome, FFQ, GPAQ
- Medical subject headings
- Diabetes Mellitus, Type 2, Genetic Predisposition to Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
16S rRNA gene sequencingDiagnostic test
Taking a stool sample for gut microbiome DNA sequencing
DNA-microarray genotypingGenetic
Taking a saliva sample for genotyping
| Study group | Role | What they receive |
|---|---|---|
| Diagnosed Type 2 Diabetes Mellitus | Patients with incident type 2 diabetes mellitus Receives: Diagnostic Test: 16S rRNA gene sequencing; Genetic: DNA-microarray genotyping | |
| Control | Volunteers without diagnosed type 2 diabetes mellitus and who don't meet the exclusion criteria Receives: Diagnostic Test: 16S rRNA gene sequencing; Genetic: DNA-microarray genotyping |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1C
Glycated hemoglobin level
Measured: Baseline
Glucose
Fasting blood glucose level
Measured: Baseline
Gut microbiome composition of participants
Bacteria abundance obtained via sequencing the DNA extracted from the stool sample
Measured: Baseline
Genotypes of participants
Genotypes of thousands of SNPs obtained via DNA-microarray genotyping of the DNA extracted from the saliva sample
Measured: Baseline
Secondary outcomes (2)
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).
Measured: 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.
Measured: 12 months before baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2019
- Study start27 Nov 2019
- Primary completion20 Oct 2021
- Study completion25 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atlas Biomed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04113239
- Sponsor's protocol ID
- T2D+FFQ/GPAQ/Genome/Metagenome
- Status last verified
- Feb 2021
- First submitted
- 1 Oct 2019
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Genome, Gut Metagenome and Lifestyle of Patients With Incident Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT04113239
- Acronym / sponsor ID
- T2D+FFQ/GPAQ/Genome/Metagenome
- Keywords
- Gut Metagenetics, Diabetes Mellitus, Type 2, Genetics, Microbiome, FFQ, GPAQ
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Atlas BiomedIndustry (pharma, biotech, devices)
- Study start
- 27 Nov 2019 (actual)
- Primary completion
- 20 Oct 2021 (actual)
- Study completion
- 25 Nov 2021 (actual)
- First posted
- 2 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A case-control study to identify microbiome and genetic differences between healthy people and patients with incident type 2 diabetes mellitus.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diagnosed Type 2 Diabetes Mellitus | – | Diagnostic Test: 16S rRNA gene sequencing, Genetic: DNA-microarray genotypingPatients with incident type 2 diabetes mellitus |
| Control | – | Diagnostic Test: 16S rRNA gene sequencing, Genetic: DNA-microarray genotypingVolunteers without diagnosed type 2 diabetes mellitus and who don't meet the exclusion criteria |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers and patients with incident type 2 diabetes mellitus from Russia, Moscow
Key inclusion criteria (1 listed)
- Confirmed diagnosis of incident type 2 diabetes mellitus
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 16S rRNA gene sequencingTaking a stool sample for gut microbiome DNA sequencing | Diagnostic test | Control, Diagnosed Type 2 Diabetes Mellitus |
| DNA-microarray genotypingTaking a saliva sample for genotyping | Genetic | Control, Diagnosed Type 2 Diabetes Mellitus |
Primary outcome
HbA1C
Time frame: Baseline
Glycated hemoglobin level
Glucose
Time frame: Baseline
Fasting blood glucose level
Gut microbiome composition of participants
Time frame: Baseline
Bacteria abundance obtained via sequencing the DNA extracted from the stool sample
Genotypes of participants
Time frame: Baseline
Genotypes of thousands of SNPs obtained via DNA-microarray genotyping of the DNA extracted from the saliva sample
2 secondary outcomes
Physical activity questionnaire
Time frame: Baseline
Food frequency questionnaire
Time frame: 12 months before baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2 and Metagenome, run by Atlas Biomed at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1C (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2022; AzTrials last refreshed its copy on 8 Nov 2026.