| Trial ID: | L5849 |
| Source ID: | NCT06217887
|
| Associated Drug: |
Loxenatide Group
|
| Title: |
Efficacy Comparison of Polyethylene Glycol Loxenatide and Gliclazide on the Brain Function in T2DM Patients
|
| Acronym: |
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus|Cognitive Function Abnormal
|
| Interventions: |
DRUG: loxenatide Group|DRUG: Gliclazide Group
|
| Outcome Measures: |
Primary: Change of olfactory brain activation by fMRI, Whether the activation degree of olfactory task fMRI brain area in the two groups after intervention was different from that before treatment and the difference of changes between the two groups. All patients underwent odor-induced task fMRI on a 3.0T MR scanner with 222 volumes for task fMRI and 230 volumes for resting-state fMRI. The odor-induced task consisted of "fresh air" "rest" and "scent". Odor-induced brain activation was assessed by a general linear model using Statistical Parametric Mapping 12 (SPM12) software. Following extraction of the three separate conditions "fresh air," "scent," and "rest" from the whole sequence, contrasts were made for each participant between "fresh air \> rest" and "scent \> rest." Odor-induced fMRI data were analyzed in the mask of the olfactory network, including the regions of bilateral parahippocampus, amygdala, piriform cortex, insula, orbitofrontal cortex, hippocampus, and entorhinal cortices., from baseline to 4-month follow-up | Secondary: Change of cognitive function, Cognitive function were improved, which means MoCA scores were improved after treatment, the RBANS total score increased by 0.5 standard deviation compared with baseline after treatment., from baseline to 4-month follow-up|Change of metabolism, The changes of glycosylated hemoglobin among the two groups before and after intervention. The level of glycosylated hemoglobin \<7% means better glucose metabolism., from baseline to 4-month follow-up
|
| Sponsor/Collaborators: |
Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
58
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2020-05-10
|
| Completion Date: |
2024-06
|
| Results First Posted: |
|
| Last Update Posted: |
2024-01-23
|
| Locations: |
Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University, Nanjing, Jiangsu, 210008, China
|
| URL: |
https://clinicaltrials.gov/show/NCT06217887
|
