Genetics of Diabetes Audit and Research in Tayside and Scotland (GoDARTS)

• ClinicalTrials.gov Identifier: NCT02712632
• Recruitment Status: Completed
• First Posted: March 18, 2016
• Last Update Posted: April 23, 2021
• Sponsor: University of Dundee
• Information provided by (Responsible Party): University of Dundee

Study Description

Brief 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 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.

Condition or disease
Diabetes

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

• Study Type: Observational
• Actual Enrollment: 1227 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Genetics of Diabetes Audit and Research in Tayside and Scotland
• Actual Study Start Date: June 20, 2016
• Actual Primary Completion Date: December 31, 2020
• Actual Study Completion Date: December 31, 2020

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. 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

Biospecimen Retention:   Samples With DNA

At visit 1 blood samples will be collected for DNA and RNA extraction. Urine samples will be collected to measure for biomarkers. Stool samples will be collected to measure for microbiota. (Stool samples will only be collected from those patients who are initiated on metformin therapy during the study period.

For those patients who are commenced on metformin therapy during the study a second study visit is required where all blood, urine and stool samples will be repeated.

Eligibility Criteria

• Ages Eligible for Study: 16 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Probability Sample

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.

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Patients with non-type 1 diabetes who have had previous treatment with insulin or an OHA or GLP-1.

Contacts and Locations

Locations

United Kingdom

University of Dundee

Dundee, Tayside, United Kingdom, DD1 9SY

Sponsors and Collaborators

University of Dundee

Investigators

• Principal Investigator: Ewan Pearson, MBBChir PhD; University of Dundee and NHS Tayside

More Information

• Responsible Party: University of Dundee
• ClinicalTrials.gov Identifier: NCT02712632
• Other Study ID Numbers: 2016DM03 GoDARTS-Scotland
• First Posted: March 18, 2016
• Last Update Posted: April 23, 2021
• Last Verified: April 2021

Additional relevant MeSH terms:

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases