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

Phase 4Enrolling By InvitationNCT06959784

China-Japan Friendship Hospital142 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

142

Conditions

Diabetes Mellitus Cardiovascular Diseases

Eligibility

Sex: ALLMin age: 30 YearsMax age: 70 Years

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

Cardiovascular and cerebrovascular event risk score

The cardiovascular and cerebrovascular event score (0-100%)is based on the cardiovascular and cerebrovascular event risk prediction model for diabetic patients established in Objective 1. In this prediction model, age, gender, smoking status, body mass index, waist circumference, glycated hemoglobin, blood sugar, blood pressure, and blood lipids correspond to certain scores. Higher scores indicate a higher risk of cardiovascular and cerebrovascular events and a worse outcome.

Time frame: One-year follow-up

Major Adverse Cardiovascular Events

The Mace event includes cardiovascular death, non-fatal myocardial infarction and non-fatal stroke.

Time frame: Baseline and every 12 weeks until 96 weeks

Cerebrovascular disease events

Cerebrovascular diseases include ischemic stroke, hemorrhagic stroke, transient ischemic attack, cerebral vascular malformation, etc.

Time frame: Baseline and every 12 weeks until 96 weeks

Secondary Outcomes

The remission rate of diabetes

Time frame: at 9 months, 1 year and 2 years of follow-up

Glycated hemoglobin

Reduced levels of glycated hemoglobin

Time frame: Baseline and every 12 weeks until 96 weeks

Fasting and postprandial blood glucose levels

Time frame: at 2 year and 8 year of follow-up

pancreatic islet function

The study evaluated pancreatic islet cell function by testing fasting insulin, insulin one hour after a steamed bread meal, and insulin two hours after a steamed bread meal.