The T2D Profile - Studies of the Omics Profile in Type 2 Diabetes

Göteborg University

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Study type: Observational

Funder types: Other

Identifiers

NCT06905717

448-16

Details and patient eligibility

About

The T2D Profile study examines the longitudinal molecular profiles of newly diagnosed type 2 diabetes (T2D), before and during guideline-based diabetes treatment.

Full description

The study included a total of 3 visits: At baseline and after 1 and 3 months of diabetes treatment according to standard of care. Visits included clinical examinations, questionnaires and clinical chemistry. In addition, samples were collected at each visits for comprehensive molecular profiling including proteomics, genomics, transcriptomics, metabolomics, lipidomics, antibody profiling, mass cytometry and gene profiling of fecal microbiota.

Enrollment: 52 patients

Sex: All

Ages: 50 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed informed consent to participate in the study.
• Age 50-65 years.
• T2D diagnosis (fasting p-glucose ≥7.0 mmol/L or an oral glucose tolerance test 2 hour p-glucose ≥11.1 mmol/L [or ≥12.2 mmol/L if measured capillary] at two separate occasions).

Exclusion criteria

• Diabetes medication before study start.
• Severe hyperglycemia requiring hospitalization or immediate insulin treatment, as judged by the investigator.
• Presence of any clinically significant disease which, in the opinion of the investigator, may interfere with the subject´s ability to participate in the study.
• Any major surgical procedure or trauma within 4 weeks of the first study visit.