Status:

ENROLLING_BY_INVITATION

Assessing Incretin Therapy for Cardiovascular Risk Reduction and Diabetes Remission( ITCRDR Study)

Lead Sponsor:

China-Japan Friendship Hospital

Conditions:

Diabetes Mellitus

Cardiovascular Diseases

Eligibility:

All Genders

30-70 years

Phase:

PHASE4

Brief Summary

This study used the diabetes prevention and follow-up research queue in Daqing and the public database of UKbiobank to evaluate the risk factors of cardiovascular and cerebrovascular events in diabete...

Eligibility Criteria

Inclusion

  • Newly diagnosed diabetes, with no previous use of hypoglycemic medications or having discontinued such medications for more than 3 months.
  • Blood glucose elevation detected within one year (fasting blood glucose exceeding 7 mmol/L, postprandial blood glucose or random blood glucose exceeding 11.1 mmol/L).
  • Age between 30 and 70 years (inclusive of boundary values).
  • Hemoglobin A1c between 7% and 10% (inclusive of boundary values).
  • BMI between 24 and 32.5 kg/m² (inclusive of boundary values).

Exclusion

  • History of coronary heart disease or cerebral infarction.
  • Severe liver or kidney disease: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 3 times the upper limit of normal (ULN); glomerular filtration rate less than 30 ml/min/1.73 m².
  • History of malignant tumors.
  • Use of systemic glucocorticoids (excluding local applications or inhalants) for one week or more within the three months prior to screening.
  • Positive urine pregnancy test in women of childbearing age.
  • History of pancreatitis, or amylase and/or lipase \> 3 times the ULN.
  • Personal history or family history of medullary thyroid carcinoma (MTC) in first-degree relatives, or genetic predisposition to MTC (such as multiple endocrine neoplasia syndrome).

Key Trial Info

Start Date :

January 1 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2026

Estimated Enrollment :

142 Patients enrolled

Trial Details

Trial ID

NCT06959784

Start Date

January 1 2024

End Date

December 31 2026

Last Update

May 7 2025

Active Locations (1)

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China-Japan Friendship hospital

Beijing, China, 100029