Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Study of the Genome, Gut Metagenome and Lifestyle of Patients With Incident Type 2 Diabetes Mellitus
Verified date | February 2021 |
Source | Atlas Biomed |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
A case-control study to identify microbiome and genetic differences between healthy people and patients with incident type 2 diabetes mellitus.
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 |
Country | Name | City | State |
---|---|---|---|
Russian Federation | City Clinical Hospital V.P. Demikhova | Moscow |
Lead Sponsor | Collaborator |
---|---|
Atlas Biomed |
Russian Federation,
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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