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REVERsal to normoglycemia by Treating PREDIABETES: the REVERT-PREDIABETES trial

Status
Not yet recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-522970-35-00
Enrollment
158
Registered
2025-11-23
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-23

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

Conditions

Coronary artery disease, Prediabetes

Brief summary

Presence of a composite of retinopathy, nephropathy, neuropathy, and MASLD in patients with chronic coronary syndrome and prediabetes versus normoglycemia., Incidence of normoglycemia defined as HbA1c <39 mmol/mol after 1 year in the interventional therapy arm compared with conventional therapy.

Detailed description

To examine the 2-year incidence of recurrence of prediabetes or progression to type 2 diabetes in patients with chronic coronary syndrome and initial prediabetes treated with glucose-lowering medications for one year compared with conventional therapy., Baseline presence of a composite of retinopathy, nephropathy, and neuropathy in patients with chronic coronary syndrome and prediabetes versus normoglycemia.., Baseline presence of retinopathy, nephropathy, neuropathy or MASLD, respectively, in patients with chronic coronary syndrome and prediabetes versus normoglycemia., 1-year incidence of normoglycemia defined as HbA1c <42 mmol/mol, Change in HbA1c, Change in eGFR, Change in cystatin-C, Change in hs-CRP, Change in lipid parameters, Change in c-peptide, Change in HOMA-IR, Change in Fib-4, Change in CD163, Change in PRO-C3, Change in MASLD severity, Change in urine albumin-creatinine ratio, Change in weight, Change in waist circumference, 2-year incidence of type 2 diabetes in the interventional therapy arm compared with conventional therapy., Prevalence of prediabetes defined as HbA1c 42-47 mmol/mol in the interventional therapy arm compared with conventional therapy., Prevalence of prediabetes defined as HbA1c 39-47 mmol/mol in the interventional therapy arm compared with conventional therapy.

Interventions

DRUGDAPAGLIFLOZIN
DRUGSEMAGLUTIDE

Sponsors

Region Midtjylland
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Presence of a composite of retinopathy, nephropathy, neuropathy, and MASLD in patients with chronic coronary syndrome and prediabetes versus normoglycemia., Incidence of normoglycemia defined as HbA1c <39 mmol/mol after 1 year in the interventional therapy arm compared with conventional therapy.

Secondary

MeasureTime frame
To examine the 2-year incidence of recurrence of prediabetes or progression to type 2 diabetes in patients with chronic coronary syndrome and initial prediabetes treated with glucose-lowering medications for one year compared with conventional therapy., Baseline presence of a composite of retinopathy, nephropathy, and neuropathy in patients with chronic coronary syndrome and prediabetes versus normoglycemia.., Baseline presence of retinopathy, nephropathy, neuropathy or MASLD, respectively, in patients with chronic coronary syndrome and prediabetes versus normoglycemia., 1-year incidence of normoglycemia defined as HbA1c <42 mmol/mol, Change in HbA1c, Change in eGFR, Change in cystatin-C, Change in hs-CRP, Change in lipid parameters, Change in c-peptide, Change in HOMA-IR, Change in Fib-4, Change in CD163, Change in PRO-C3, Change in MASLD severity, Change in urine albumin-creatinine ratio, Change in weight, Change in waist circumference, 2-year incidence of type 2 diabetes in the inte

Countries

Denmark

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026