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Clinical Trial Details

Trial ID: L4769
Source ID: NCT06085703
Associated Drug: Henagliflozin
Title: Effects of Henagliflozin on the Brain Function in T2DM Patients With Mild Cognitive Impairment: a Randomized, Parallel Controlled Clinical Trial
Acronym:
Status: RECRUITING
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus|Mild Cognitive Impairment
Interventions: DRUG: Henagliflozin|DRUG: Gliclazide
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 6-month follow-up | Secondary: Change of cognitive function, Type 2 diabetes mellitus patients with MCI were relieved of mild cognitive impairment , which means MoCA scores were not less than 26 points after treatment, or improved referring to the MoCA score or the RBANS total score increased by 0.5 standard deviation compared with baseline after treatment., from baseline to 6-month follow-up|Olfactory threshold test, Whether the olfactory threshold scores of the two groups after intervention were higher than those before treatment and the difference of changes between the two groups. Olfactory testing was performed using Olfactory Function Assessment by Computerized Testing (OLFACT) (Osmic Enterprises, Inc.). Based on the University of Pennsylvania Smell Identification Test (UPSIT), OLFACT tests were computerized, standardized, and self-administered. Higher scores indicated better ability to detect odors. Threshold testing was performed by a series of binary dilutions of n-butanol solution in light mineral oil, and scores ranged from 1 to 13.5., from baseline to 6-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 6-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: 60
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-09-01
Completion Date: 2026-06-30
Results First Posted:
Last Update Posted: 2023-10-17
Locations: Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University, Nanjing, Jiangsu, 210008, China
URL: https://clinicaltrials.gov/show/NCT06085703