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

NCT ID: NCT06905717

Last Updated: 2025-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

52 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-15

Study Completion Date

2018-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Diabetes Mellitus, Type 2

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Göteborg University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Göran Bergström, MD, Prof

Role: PRINCIPAL_INVESTIGATOR

Göteborg University

References

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Gummesson A, Bjornson E, Fagerberg L, Zhong W, Tebani A, Edfors F, Schmidt C, Lundqvist A, Adiels M, Backhed F, Schwenk JM, Jansson PA, Uhlen M, Bergstrom G. Longitudinal plasma protein profiling of newly diagnosed type 2 diabetes. EBioMedicine. 2021 Jan;63:103147. doi: 10.1016/j.ebiom.2020.103147. Epub 2020 Dec 3.

Reference Type BACKGROUND
PMID: 33279861 (View on PubMed)

Other Identifiers

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448-16

Identifier Type: -

Identifier Source: org_study_id

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