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

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

Detailed Description
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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.

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

Conditions
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Diabetes Mellitus, Type 2, Metagenome, Genetic Predisposition

Intervention / Treatment
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* Diagnostic Test: 16S rRNA gene sequencing
* Genetic: DNA-microarray genotyping


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Diagnosed Type 2 Diabetes Mellitus<br>Patients with incident type 2 diabetes mellitus | Diagnostic Test: 16S rRNA gene sequencing<br>* Taking a stool sample for gut microbiome DNA sequencing<br>Genetic: DNA-microarray genotyping<br>* Taking a saliva sample for genotyping<br>|
| Control<br>Volunteers without diagnosed type 2 diabetes mellitus and who don't meet the exclusion criteria | Diagnostic Test: 16S rRNA gene sequencing<br>* Taking a stool sample for gut microbiome DNA sequencing<br>Genetic: DNA-microarray genotyping<br>* Taking a saliva sample for genotyping<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gut Metagenetics, Diabetes Mellitus, Type 2, Genetics, Microbiome, FFQ, GPAQ