Comparing the effects of loxenatide and gliclazide on brain function in diabetes patients
Efficacy Comparison of Polyethylene Glycol Loxenatide and Gliclazide on the Brain Function in T2DM Patients: a Randomized, Parallel Controlled Clinical Trial
This study is testing whether loxenatide or gliclazide can improve brain function in people with Type 2 Diabetes who have normal or slightly impaired thinking skills.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 58 (estimated) |
| Ages | 40 Years to 75 Years |
| Sex | All |
| Sponsor | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT06217887 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effects of polyethylene glycol loxenatide on cognitive and olfactory functions in patients with Type 2 Diabetes Mellitus (T2DM) who have normal cognitive status or mild cognitive impairment. It is a prospective, randomized, open-label trial lasting four months, where participants will be divided into two groups: one receiving loxenatide and the other receiving gliclazide, while continuing their metformin treatment. The study will assess various parameters including cognitive assessments, olfactory tests, and functional MRI scans to measure brain activation in response to odors. A total of 58 patients will be enrolled and monitored throughout the study period.
Who should consider this trial
Good fit: Ideal candidates are adults aged 40-75 with Type 2 Diabetes Mellitus, normal cognitive function or mild cognitive impairment, and stable metformin treatment.
Not a fit: Patients with severe cognitive impairment, significant liver or kidney dysfunction, or those unable to undergo MRI scans may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve cognitive and olfactory functions in T2DM patients, potentially enhancing their quality of life.
How similar studies have performed: While there have been studies on diabetes and cognitive function, the specific use of loxenatide in this context is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * patients with type 2 diabetes mellitus ; * Aged:40 -75 years ; * Cognitive function assessment suggests normal status or mild cognitive impairment; * a stable dose of metformin monotherapy (≥1,500 mg daily) for at least 90 days, * HbA1c 7 - 10%; * ≥6 years of education; * Right-handed. Exclusion Criteria: * patients unable to complete brain MRI scanning; * nasal disease that affected olfactory function; * hepatic dysfunction with liver transaminases \> 2.5 times upper normal limits and renal impairment with an estimated glomerular filtration rate \< 60ml/min/1.73m2 ; * acute cardio/cerebrovascular disease, psychiatric disorders, pancreatitis, acute infection, malignant tumor,thyroid disease and homorne drug use; * a history of related drug allergy; * alcohol or drug misuse; * pregnant, breast-feeding or intending to become pregnant.
Where this trial is running
Nanjing, Jiangsu
- Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Study coordinator: Yan Bi, MD, PhD
- Email: biyan@nju.edu.cn
- Phone: 86-25-83-105302
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.