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Integration of Metabolomics and Multi-Modal fMRI Functional Imaging Techniques to Investigate the Role and Mechanisms of GLP-1 Receptor Agonist PEG-Loxenatide in Alleviating Early Damage in Diabetic Cardiomyopathy

Integration of Metabolomics and Multi-Modal fMRI Functional Imaging Techniques to Investigate the Role and Mechanisms of GLP-1 Receptor Agonist PEG-Loxenatide in Alleviating Early Damage in Diabetic Cardiomyopathy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300079158
Enrollment
Unknown
Registered
2023-12-26
Start date
2024-01-01
Completion date
Unknown
Last updated
2024-01-08

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

Conditions

diabetes

Interventions

One:Treatment of PEG-Loxenatide
Two:Insulin glargine

Sponsors

Chu Hsien-lMemorial Hospital of TianjinMedical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.Definite diagnosis of type 2 diabetes (using the 1999 WHO diagnostic criteria). 2.Not previously treated with anti-diabetic medications, or if treated with metformin alone, the duration should be no less than 8 weeks, with HbA1C levels between 7% and 9.0%. Duration of diabetes is less than 10 years. 3.Age is greater than or equal to 18 years old and less than 70 years old. 4.Family history of type 2 diabetes-related cardiomyopathy. 5.BMI greater than or equal to 28kg/m². 6.Other treatments: including stable lipid-lowering, blood pressure management, antiplatelet therapy, etc., for a duration of at least 3 months. 7.Willing to participate in and cooperate with the study, and signing the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Type 1 diabetes; 2.Currently using glucocorticoids and other medications affecting blood sugar, or screened within the last 3 months for the use of GLP-1 receptor agonists or DPP4 enzyme inhibitors; 3.Allergic to GLP-1 receptor agonists; 4.Experienced acute complications of diabetes in the last 2 months, such as diabetic ketoacidosis, hyperosmolar hyperglycemic state, lactic acidosis, etc.; 5.History of compromised immune function or malignant tumors, family or personal history of type 2 multiple endocrine neoplasia (MEN2), familial medullary thyroid carcinoma (FMTC), or personal history of non-familial medullary thyroid carcinoma; calcitonin greater than or equal to 50ng/L; 6.History of acute or chronic pancreatitis; 7.Experienced acute myocardial infarction, cerebrovascular accident, or severe infection within the 6 months prior to enrollment; 8.Uncontrolled hypertension: systolic blood pressure greater than 180mmHg and/or diastolic blood pressure greater than 110mmHg; 9.Abnormal liver function, with ALT or AST levels exceeding three times the normal upper limit; 10.Previously undergone percutaneous coronary intervention; individuals with arterial aneurysms; patients with cardiac pacemakers, nerve stimulators, artificial metallic heart valves, etc.; those with intraocular metal foreign bodies, implanted inner ear devices, metal prosthetics, metal joints, or ferromagnetic foreign bodies within the body; 11.Pregnant or planning to become pregnant, women in lactation; 12.Epilepsy, claustrophobia, or patients unable to cooperate with magnetic resonance imaging (MRI); 13.History of mental illness or individuals not adhering to the study plan and unable to perform research tasks.

Design outcomes

Primary

MeasureTime frame
Balanced Turbo Field Echo;Characteristics of myocardial tissue;

Secondary

MeasureTime frame
height;weight;blood pressure;heart rate;Liver function;kidney function;OGTT;HbA1c;blood lipids;UCG;ACR;uma;ROS;Hs-CRP;

Countries

China

Contacts

Public ContactHongyan Liu

Chu Hsien-lMemorial Hospital of TianjinMedical University

liuhongyan0323@126.com+86 136 6207 9378

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026