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Type 2 diabetes examining complications study

Early onset type 2 diabetes complication rates in Aotearoa New Zealand

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12626000755336
Acronym
TYDES
Enrollment
164
Registered
2026-06-25
Start date
2026-07-13
Completion date
2028-01-10
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Type 2 diabetes (T2D) is increasingly being seen in young people in Aotearoa New Zealand and internationally. There is growing understanding that it may be a more severe form of T2D however little is known about what this looks like for young New Zealanders. This study will recruit young adults aged 40 years with T2D. Using photographs of the eyes, blood and urine tests, and an examination of the feet we will assess and compare each group. The study is designed to see whether early diabetic changes to the eyes, kidneys and nerves are more common in younger people.

Interventions

The study will prospectively assess a group of participants aged less than 40 with a history of type 2 diabetes of less than 10 years duration. Data will be collected at a single time point for each participant. Assessment of microvascular diabetes complications of retinopathy, neuropathy and nephropathy will be made with use of retinal photographs, serum and urine biochemistry and lower limb physical examination. Additional observations of macrovascular diabetes complications on history, ankle

The study will prospectively assess a group of participants aged less than 40 with a history of type 2 diabetes of less than 10 years duration. Data will be collected at a single time point for each participant. Assessment of microvascular diabetes complications of retinopathy, neuropathy and nephropathy will be made with use of retinal photographs, serum and urine biochemistry and lower limb physical examination. Additional observations of macrovascular diabetes complications on history, ankle-brachial indices, toe pressure and lower limb arterial doppler ultrasound will be made. Glycaemia, insulin production and resistance will be assessed through medical history and serum biochemistry. Anthropometry will be assessed using bio-impedance scales, stadiometer and tape measure. Serum lipids will be measured. Physical examination, blood and urine collection other testing is estimated to take 1.5-2 hours. Retinal images will be taken with technicians in optometry or ophthalmology services. Blood collection and all other assessments will be performed by medically trained investigators. Participants will be interviewed to provide demographic, social, medical and medication histories and will undertake questionnaires on diabetes distress (Diabetes Distress Scale), quality of life (SF-36) and physical activity (IPAQ-SF). The obstructive sleep apnoea risk score (STOP-BANG) will be completed. Questionnaires are expected to take 40 minutes to complete with a further 30 minutes of social and medical history. Questionnaires may be completed by participants prior to the study visit at their preference. The majority of assessments will be completed in a single study visit however a separate visit for retinal imaging may be required if existing photographs aren't available. Participants may elect to undertake some of the assessments in a second study visit if a single longer visit is not favoured.

Sponsors

University of Otago
Lead SponsorUniversity

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1) Age of 18 or greater. 2) A diagnosis of type 2 diabetes within 10 years based on documented serum HbA1c or glucose levels. 3) Ability to give written and verbal consent and participate in the study.

Exclusion criteria

1) History of type 1 diabetes, monogenic, syndromic or secondary diabetes (post-pancreatectomy, chronic pancreatitis, cystic fibrosis related, transplant associated). 2) Positive anti-GAD-65 or IA2 antibody. 3) C-peptide less than 200 pmol/L. 4) History of ketoacidosis in the absence of SGLT-2 inhibitor use. 5) Familial hypercholesterolaemia. 6) Pregnancy or breastfeeding. 7) Current or recent participation in an interventional trial. 8) Significant primary renal or neurological condition.

Outcome results

None listed

Source: ANZCTR · Data processed: Jul 3, 2026