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

March 31, 2025 updated by: Göteborg University
The T2D Profile study examines the longitudinal molecular profiles of newly diagnosed type 2 diabetes (T2D), before and during guideline-based diabetes treatment.

Study Overview

Status

Completed

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Actual)

52

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Subjects with newly diagnosed Type 2 Diabetes identified from population-based cohorts.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Molecular profiles during diabetes treatment
Time Frame: 3 months
Protein profiles will be compared between diabetes and control and diabetes treatment
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Göteborg University

Investigators

  • Principal Investigator: Göran Bergström, MD, Prof, Göteborg University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2016

Primary Completion (Actual)

June 25, 2018

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

March 2, 2021

First Submitted That Met QC Criteria

March 31, 2025

First Posted (Actual)

April 1, 2025

Study Record Updates

Last Update Posted (Actual)

April 1, 2025

Last Update Submitted That Met QC Criteria

March 31, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 448-16

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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