Diabetes Mellitus, Type 2NCT06905717
The T2D Profile - Studies of the Omics Profile in Type 2 Diabetes
An observational study of Diabetes Mellitus, Type 2, run by Göteborg University.
Trial summary
The T2D Profile study examines the longitudinal molecular profiles of newly diagnosed type 2 diabetes (T2D), before and during guideline-based diabetes treatment. Read more about this study
- Who is it for?
- Ages 50 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2016to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with newly diagnosed Type 2 Diabetes identified from population-based cohorts.
Who may be able to join
- 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).
Who cannot join
- 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.
About this study
The T2D Profile study examines the longitudinal molecular profiles of newly diagnosed type 2 diabetes (T2D), before and during guideline-based diabetes treatment.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2
- Medical subject headings
- Diabetes Mellitus, Type 2
What is being measured
The primary outcome is the main question the study is designed to answer.
Molecular profiles during diabetes treatment
Protein profiles will be compared between diabetes and control and diabetes treatment
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2025
- Study start15 Jun 2016
- Primary completion25 Jun 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Göran Bergström, MD, Prof, Principal investigator, Göteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06905717
- Sponsor's protocol ID
- 448-16
- Status last verified
- Mar 2025
- First submitted
- 2 Mar 2021
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33279861
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The T2D Profile - Studies of the Omics Profile in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT06905717
- Acronym / sponsor ID
- 448-16
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Study start
- 15 Jun 2016 (actual)
- Primary completion
- 25 Jun 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 1 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with newly diagnosed Type 2 Diabetes identified from population-based cohorts.
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Molecular profiles during diabetes treatment
Time frame: 3 months
Protein profiles will be compared between diabetes and control and diabetes treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Background: PubMed 33279861Gummesson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Göran Bergström, MD, Prof principal investigator
Göteborg University
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2, run by Göteborg University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Molecular profiles during diabetes treatment (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06905717, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025.