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Completed

NCT Number: NCT06905717

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

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Primary outcomes

  1. Molecular profiles during diabetes treatment

    Time frame: 3 months

    Protein profiles will be compared between diabetes and control and diabetes treatment

Sponsors and collaborators

Lead sponsor

Göteborg University

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Apr 1, 2025
Registry last updated
Apr 1, 2025

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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