DiabetesGoDARTSNCT02712632
Genetics of Diabetes Audit and Research in Tayside and Scotland
An observational study of Diabetes, run by University of Dundee at 1 site in United Kingdom.
Trial summary
The GoDARTS study will encompass all patients, with diabetes, aged 16 and upwards who meet the planned inclusion criteria. The study aims to investigate biomarkers associated with diabetes progression, therapeutic response, diabetes complications and related traits, and specifically to investigate mechanisms of action… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Diabetes
- How many people
- 1,227 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Jun 2016to 31 Dec 2020
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The patients for this study will be identified from the SDRN and SHARE Research Registers. (These patients have given prior consent to be contacted about research studies.) Patients will also be selected from secondary and primary care clinics.
Who may be able to join
- Adults aged 16 and over.
- Diagnosis of diabetes within the past 2 years.
- Either Non-Type 1 diabetes controlled by diet only with an HbA1c ≥ 48; or Type 1 diabetes
- Able to give informed consent.
Who cannot join
- Patients with non-type 1 diabetes who have had previous treatment with insulin or an OHA or GLP-1.
Trial locations and contacts
1 site in 1 country.
About this study
The GoDARTS study will encompass all patients, with diabetes, aged 16 and upwards who meet the planned inclusion criteria. The study aims to investigate biomarkers associated with diabetes progression, therapeutic response, diabetes complications and related traits, and specifically to investigate mechanisms of action and response to metformin. The study will specifically target patients who have been diagnosed within the past 2 years and follow up will be by linkage to electronic health record data. Up to 6,000 patients will be recruited into the study over a period of 2-3 years with a primary aim to identify 1000 of these patients who should be suitable to be started on metformin therapy.
Most patients will undergo a single screening visit lasting approximately 20 minutes conducted on an outpatient basis. Patients commenced on metformin therapy will need to attend a second clinic visit to be carried out between 4-6 months after initiation of metformin therapy.
Read more
Up to 9 health boards will be approached regarding participating in the study, and it is estimated that between 4-6 diabetes patients will be recruited into the study each week, at each site.
All screened patients will provide consent for data linkage and longitudinal follow up and their samples and data will be used to supplement the SHARE/SDRN bioresource. The collection into the resource will be managed by the co-ordinating centre study team based at the University of Dundee/NHS Tayside. The resource will be hosted by the Tayside Biorepository and access to samples and data will be managed by the Tayside Biorepository on behalf of the whole of Scotland.
Read the detailed description
This GoDARTS-Scotland proposal aims to investigate biomarkers associated with diabetes progression, therapeutic response, diabetes complications and related traits, and specifically to investigate mechanisms of action and response to metformin. GoDARTS-Scotland will specifically target the patient group who have been diagnosed with diabetes in the previous 2 years and follow up will be by linkage to electronic health record data.
The study will, for the most part, involve a single study visit lasting approximately 20 minutes. Informed consent will be obtained before any study procedures are carried out.
In addition, those patients who are not on metformin will undergo more comprehensive sampling and a second visit, between four to six months, after initiation of metformin. As current guidelines suggest all patients who are newly diagnosed with type 2 diabetes should be treated with metformin the investigator will ask the patient and General Practitioner to consider initiation of metformin, although this is a clinical decision that will be made by the GP. Between four to six months after commencement of Metformin the patient will be asked to return to the clinic for a second visit where additional samples and measures will be taken.
The investigator plans to recruit patients aged 16 and upwards with a diagnosis of diabetes from several Scottish Health Boards.
The Resource will be hosted by the Tayside Biorepository which is part of the East of Scotland Tissue Bank. Access to samples and data will be managed by the Tayside Biorepository on behalf of the whole of Scotland. All initial requests for access will be made to the Tayside Biorepository Access Committee who will manage the process and send requests for access to data to the relevant access committees.
All eligible patients will be recruited into this study from February 2016 until January 2019 and this will allow any necessary follow up visits to take place.
- Conditions
- Diabetes
- Medical subject headings
- Diabetes Mellitus
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c reduction.
For the primary analysis on the determinants of metformin response the primary outcome is HbA1c reduction
Measured: 6 months to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2016 (estimated)
- Study start20 Jun 2016
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- 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
- 1,227 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Dundee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ewan Pearson, MBBChir PhD, Principal investigator, University of Dundee and NHS Tayside
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02712632
- Sponsor's protocol ID
- 2016DM03 GoDARTS-Scotland
- Acronym
- GoDARTS
- Status last verified
- Apr 2021
- First submitted
- 12 Feb 2016
- Last updated
- 23 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetics of Diabetes Audit and Research in Tayside and Scotland
- ClinicalTrials.gov ID
- NCT02712632
- Acronym / sponsor ID
- GoDARTS / 2016DM03 GoDARTS-Scotland
- Conditions
- Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,227 participants (actual)
- Lead sponsor
- University of DundeeUniversity, hospital or other
- Study start
- 20 Jun 2016 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 18 Mar 2016 (estimated)
- 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 GoDARTS study will encompass all patients, with diabetes, aged 16 and upwards who meet the planned inclusion criteria. The study aims to investigate biomarkers associated with diabetes progression, therapeutic response, diabetes complications and related traits, and specifically to investigate mechanisms of action and response to metformin. The study will specifically target patients who have been diagnosed within the past 2 years and follow up will be by linkage to electronic health record data. Up to 6,000 patients will be recruited into the study over a period of 2-3 years with a primary aim to identify 1000 of these patients who should be suitable to be started on metformin therapy.
Most patients will undergo a single screening visit lasting approximately 20 minutes conducted on an outpatient basis. Patients commenced on metformin therapy will need to attend a second clinic visit to be carried out between 4-6 months after initiation of metformin therapy.
Up to 9 health boards will be approached regarding participating in the study, and it is estimated that between 4-6 diabetes patients will be recruited into the study each week, at each site.
All screened patients will provide consent for data linkage and longitudinal follow up and their samples and data will be used to supplement the SHARE/SDRN bioresource. The collection into the resource will be managed by the co-ordinating centre study team based at the University of Dundee/NHS Tayside. The resource will be hosted by the Tayside Biorepository and access to samples and data will be managed by the Tayside Biorepository on behalf of the whole of Scotland.
Detailed description
This GoDARTS-Scotland proposal aims to investigate biomarkers associated with diabetes progression, therapeutic response, diabetes complications and related traits, and specifically to investigate mechanisms of action and response to metformin. GoDARTS-Scotland will specifically target the patient group who have been diagnosed with diabetes in the previous 2 years and follow up will be by linkage to electronic health record data.
The study will, for the most part, involve a single study visit lasting approximately 20 minutes. Informed consent will be obtained before any study procedures are carried out.
In addition, those patients who are not on metformin will undergo more comprehensive sampling and a second visit, between four to six months, after initiation of metformin. As current guidelines suggest all patients who are newly diagnosed with type 2 diabetes should be treated with metformin the investigator will ask the patient and General Practitioner to consider initiation of metformin, although this is a clinical decision that will be made by the GP. Between four to six months after commencement of Metformin the patient will be asked to return to the clinic for a second visit where additional samples and measures will be taken.
The investigator plans to recruit patients aged 16 and upwards with a diagnosis of diabetes from several Scottish Health Boards.
The Resource will be hosted by the Tayside Biorepository which is part of the East of Scotland Tissue Bank. Access to samples and data will be managed by the Tayside Biorepository on behalf of the whole of Scotland. All initial requests for access will be made to the Tayside Biorepository Access Committee who will manage the process and send requests for access to data to the relevant access committees.
All eligible patients will be recruited into this study from February 2016 until January 2019 and this will allow any necessary follow up visits to take place.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The patients for this study will be identified from the SDRN and SHARE Research Registers. (These patients have given prior consent to be contacted about research studies.) Patients will also be selected from secondary and primary care clinics.
Key inclusion criteria (4 listed)
- Adults aged 16 and over.
- Diagnosis of diabetes within the past 2 years.
- Either Non-Type 1 diabetes controlled by diet only with an HbA1c ≥ 48; or Type 1 diabetes
- Able to give informed consent.
Key exclusion criteria (1 listed)
- Patients with non-type 1 diabetes who have had previous treatment with insulin or an OHA or GLP-1.
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
HbA1c reduction.
Time frame: 6 months to 1 year
For the primary analysis on the determinants of metformin response the primary outcome is HbA1c reduction
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 23 Apr 2021.
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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.
Ewan Pearson, MBBChir PhD principal investigator
University of Dundee and NHS Tayside
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes, run by University of Dundee at 1 site in United Kingdom.
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 4 inclusion and 1 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 23 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
HbA1c reduction. (time frame: 6 months to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Apr 2021.