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Completed

NCT Number: NCT04113239

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Disease Attributes Disease Susceptibility Endocrine System Diseases Genetic Predisposition Genetic Predisposition to Disease Glucose Metabolism Disorders Metabolic Diseases Metagenome Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

City Clinical Hospital V.P. Demikhova

Moscow, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

16S rRNA gene sequencing

Diagnostic Test

Taking a stool sample for gut microbiome DNA sequencing

DNA-microarray genotyping

Genetic

Taking a saliva sample for genotyping

Primary outcomes

  1. HbA1C

    Time frame: Baseline

    Glycated hemoglobin level

  2. Glucose

    Time frame: Baseline

    Fasting blood glucose level

  3. Gut microbiome composition of participants

    Time frame: Baseline

    Bacteria abundance obtained via sequencing the DNA extracted from the stool sample

  4. Genotypes of participants

    Time frame: Baseline

    Genotypes of thousands of SNPs obtained via DNA-microarray genotyping of the DNA extracted from the saliva sample

Secondary outcomes

  1. Physical activity questionnaire

    Time frame: Baseline

    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).

  2. Food frequency questionnaire

    Time frame: 12 months before baseline

    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.

Sponsors and collaborators

Lead sponsor

Atlas Biomed

Industry

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Oct 2, 2019
Registry last updated
Jul 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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