Effects of Liraglutid, Dapagliflozin and Acarbose on the Cognitive Function, Olfactory Function, … (NCT03961659) | Clinical Trial Compass
UnknownNot Applicable
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.
China87 participantsStarted 2019-05
Plain-language summary
This is a prospective, randomized, open label, parallel, 16-week study to explore and evaluate the therapeutic effects of liraglutid, dapagliflozin and acarbose on the cognitive function, olfactory function, and odor-induced brain activation in overweight/obese patients with type 2 diabetes mellitus(T2DM) inadequately controlled with metformin monotherapy.
Who can participate
Age range40 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≧ 40 and ≦75 years old
* T2DM patients controlled with metformin monotherapy with stable, maximum tolerated doses (≧1500mg/d, ≧12 weeks)
* HbA1c\>7% and ≤9%
* Body mass index(BMI) ≥25kg/m2 and with stable weight during previous 3 months
* Right handedness
* Possessed over 6-year education
* Provision of informed consent prior to any study specific procedures
* Mini-Mental State Examination (MMSE) \>24
Exclusion Criteria:
* Allergies to research drugs
* Treated with glucagon-like peptide-1 receptor agonists, dipeptidyl peptidase-4 inhibitors, sodium-glucose cotransporter 2 inhibitors, insulins, and glycosidase inhibitors in the previous 6 months
* Moderate to severe renal dysfunction defined as estimated glomerular filtration rate(eGFR)\<60ml/min/1.73m2 ( eGFR was estimated by CKD-EPI creatinine equation using an online calculator).
* Hepatic insufficiency
* A history of neurological and psychiatric disorders, nasal pathologies, abnormal thyroid, pancreatitis, repeated urinary tract infection, chronic gastrointestinal dysfunction, any disease that may worsen by intestinal flatulence, alcohol or substance abuse, steroid treatment
* Any acute disease
* Inability to undergo tests or MRI scanning
* Pregnant or lactating women
* Participating in other clinical trials at the same time or within 6 months prior to the start of the trial
What they're measuring
1
Change of olfactory brain activation by fMRI
Timeframe: from baseline to 16 weeks' follow-up.
Trial details
NCT IDNCT03961659
SponsorThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School