| Trial ID: | L5353 |
| Source ID: | NCT03961659
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| Associated Drug: |
Liraglutid
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| Title: |
Effects of Liraglutid, Dapagliflozin and Acarbose on the Cognitive Function, Olfactory Function, and Odor-induced Brain Activation in Overweight/Obese T2DM Patients Controlled Inadequately With Metformin Monotherapy.
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| Acronym: |
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| Status: |
UNKNOWN
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| Study Results: |
NO
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| Results: |
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| Conditions: |
Type 2 Diabetes Mellitus|Obesity|Cognitive Impairment
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| Interventions: |
DRUG: Liraglutid|DRUG: Dapagliflozin|DRUG: Acarbose
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| Outcome Measures: |
Primary: Change of olfactory brain activation by fMRI, Compare the change of olfactory brain activation by fMRI from baseline to 16 weeks' follow-up, from baseline to 16 weeks' follow-up. | Secondary: Change of cognitive function, Compare the change of Montreal Cognitive Assessment (MoCA, beijing version) from baseline to 16 weeks' follow-up. MoCA score(ranging from 0 to 30)\<26 is considered cognitive impairment and when the score is lower, the cognitive impairment is more serious. MoCA score ≥26 is considered normal cognition., from baseline to 16 weeks' follow-up.|Proportion of patients whose MoCA<26 scores, Compare the proportion of patients whose MoCA\<26 scores at baseline and at 16 weeks' follow-up., at baseline and at 16 weeks' follow-up.|Change of blood glycaemic control, Compare the change of glycosylated hemoglobin(HbA1c) from baseline to 16 weeks' follow-up, from baseline to 16 weeks' follow-up|Proportion of patients whose HbA1c<7%, Analyze the proportion of patients whose HbA1c\<7% at 16 weeks' follow-up., at 16 weeks' follow-up.|Proportion of patients whose weight loss>3% and >5%, Analyze the proportion of patients whose weight loss\>3% and \>5%, from baseline to 16 weeks' follow-up.|Olfactory threshold test, The olfactory threshold test (score range 1-13.5) is determined based on a series of binary dilutions of the N-butanol solution in light mineral oil. The higher the score is, the more sensitive the participant is in detecting an odor. Scores of 8-10 were considered normal olfactory sensitivity, whereas scores of 1-3 signified olfactory dysfunction or anosmia, and scores of ≥10 indicate better olfactory sensitivity., from baseline to 16 weeks' follow-up.
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| Sponsor/Collaborators: |
Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
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| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
|
| Enrollment: |
87
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| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
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| Start Date: |
2019-05
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| Completion Date: |
2021-02
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| Results First Posted: |
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| Last Update Posted: |
2019-05-23
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| Locations: |
at Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University, Nanjing, Jiangsu, 210008, China
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| URL: |
https://clinicaltrials.gov/show/NCT03961659
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