Genetics of Diabetes Audit and Research in Tayside and Scotland

NCT02712632 | Completed

• 1 other identifier: 2016DM03 GoDARTS-Scotland
• Study Type: observational
• Target: 1,227
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

• HbA1c reduction.

  For the primary analysis on the determinants of metformin response the primary outcome is HbA1c reduction

  6 months to 1 year

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Dundee: lead

Study Sites (1)

University of Dundee

Dundee, Tayside, DD1 9SY, United Kingdom

Location

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.

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Ewan Pearson, MBBChir PhD

  University of Dundee and NHS Tayside

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2016
• First Posted: March 18, 2016
• Study Start: June 20, 2016
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: April 23, 2021

Record last verified: 2021-04

Locations

GB (1)