Clinical trial NCT06959784: Assessing Incretin Therapy for Cardiovascular Risk Reduction and Diabetes Remission( ITCRDR Study)
Official title: Evidence Based Evaluation of Incretin Drugs in Reducing the Risk of Cardiovascular and Cerebrovascular Events and Promoting the Remission of Diabetes
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE4
Conditions: Diabetes Mellitus
Cardiovascular Diseases
Cerebrovascular Disease
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
First posted: 2025-05-07
Enrollment: 142
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 diabetes patients, and built the first risk prediction model of cardiovascular and cerebrovascular events in diabetes patients based on the Chinese population follow-up queue and externally verified, so as to identify high-risk groups and guide the early prevention of cardiovascular and cerebrovascular diseases in diabetes patients. To evaluate the effect of incretin drugs on reducing the risk of cardiovascular and cerebrovascular events, and the impact on the remission rate of diabetes in people with initial diabetes, a randomized, multicenter, controlled clinical study was conducted. The long-term follow-up of 2 years was conducted to evaluate whether the cardiovascular and cerebrovascular risks of those who stopped drug treatment after remission of diabetes compared with those who continued drug treatment were reduced, as well as the long-term impact of incretin on cardiovascular and cerebrovascular risks and the role of long-term mitigation of diabetes.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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).

Primary outcomes:
measure: Cardiovascular and cerebrovascular event risk score
timeFrame: One-year follow-up
measure: Major Adverse Cardiovascular Events
timeFrame: Baseline and every 12 weeks until 96 weeks
measure: Cerebrovascular disease events
timeFrame: Baseline and every 12 weeks until 96 weeks
Secondary outcomes:
measure: The remission rate of diabetes
timeFrame: at 9 months, 1 year and 2 years of follow-up
measure: Glycated hemoglobin
timeFrame: Baseline and every 12 weeks until 96 weeks
measure: Fasting and postprandial blood glucose levels
timeFrame: at 2 year and 8 year of follow-up
measure: pancreatic islet function
timeFrame: Baseline, 48 weeks and 96 weeks
measure: Heart rate
timeFrame: Baseline, 48 weeks and 96 weeks
measure: Carotid artery peak systolic velocity
timeFrame: Baseline, 48 weeks and 96 weeks
measure: Routine urine examination
timeFrame: Baseline, 48 weeks and 96 weeks
measure: Urine microalbumin
timeFrame: Baseline, 48 weeks and 96 weeks
measure: Heart rhythm
timeFrame: Baseline, 48 weeks and 96 weeks
measure: Carotid artery peak diastolic velocity
timeFrame: Baseline, 48 weeks and 96 weeks
measure: Carotid resistance index
timeFrame: Baseline, 48 weeks and 96 weeks
measure: common carotid artery diameter
timeFrame: Baseline, 48 weeks and 96 weeks
measure: Carotid artery wall thickness
timeFrame: Baseline, 48 weeks and 96 weeks
measure: Carotid Intima-media Thickness
timeFrame: Baseline, 48 weeks and 96 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan Friendship hospital
Study officials:
References: