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A clinical research on retinal microstructural changes in the acute phase of diabetic ketoacidosis based on multimodal fundus imaging and their prognostic value

A clinical research on retinal microstructural changes in the acute phase of diabetic ketoacidosis based on multimodal fundus imaging and their prognostic value

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600127140
Enrollment
Unknown
Registered
2026-06-25
Start date
2026-06-30
Completion date
Unknown
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

Diabetic Ketoacidosis (DKA) in Type 2 Diabetes

Interventions

DKA Group:none
Diabetic group without DKA:none

Sponsors

Bejing Tongren Hospital, Capital Medical Uniersity
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1. DKA Group (1) Age 18-50 years old (upper limit set at 50 to reduce interference from age-related retinal changes and cataracts, etc.); (2) Type 2 diabetes, meeting DKA diagnostic criteria (blood glucose > 13.9 mmol/L, arterial pH 3.0 mmol/L or positive urine ketones); (3) Willing to participate in this study and sign informed consent. 2. Diabetes without DKA Control Group: (1) Match control group patients by age, disease duration, and HbA1c distribution based on the enrolled DKA patients, ensuring both groups are balanced on these key confounding factors. Additional inclusion criteria: meet type 2 diabetes diagnostic criteria (same as DKA group), no DKA episodes in the past 3 months.

Exclusion criteria

Exclusion criteria: 1. Exclusion criteria for the DKA group: (1) Severe refractive media opacity (such as cataracts or corneal disease) or inability of the pupil to dilate, which affects high-quality fundus imaging; (2) Other serious eye diseases (such as glaucoma, age-related macular degeneration, retinal vascular occlusion, uveitis, etc.); (3) History of intraocular surgery (excluding cataract surgery) or retinal laser treatment; (4) Severe heart, liver, or kidney dysfunction, or pregnant women; (5) Inability to cooperate with ophthalmic examinations due to consciousness disorders or other reasons.

Design outcomes

Primary

MeasureTime frame
SCP VD;

Secondary

MeasureTime frame
Foveal Avascular Zone Area;Subfoveal Choroidal Thickness;SCP PD / DCP PD;Arterial blood gas (ABG) analysis (pH, HCO3-);INL Thickness;FAZ Perimeter;GCIPL Thickness;DCP VD;ß-hydroxybutyrate;Central Macular Thickness;

Countries

China

Contacts

Public ContactHaibo Zhang

Beijing Tongren Hospital, Capital Medical University

amzhb@163.com+86 10 58533089

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 3, 2026