Status:
ACTIVE_NOT_RECRUITING
LIGHT-MCI Trial: GLP-1 Agonist, SGLT2 Inhibitor, and DPP-4 Inhibitor for MCI Remission in Type 2 Diabetes
Lead Sponsor:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Collaborating Sponsors:
Nanjing First Hospital, Nanjing Medical University
The Affiliated Jiangning Hospital of Nanjing Medical University
Conditions:
Type 2 Diabetes Mellitus
Mild Cognitive Impairment
Eligibility:
All Genders
40-75 years
Phase:
NA
Brief Summary
This is an investigator-led prospective, randomized, open label, parallel study to explore and evaluate the therapeutic effects of Liraglutide, Empagliflozin and Linagliptin on the cognitive function ...
Detailed Description
The LIGHT-MCI trial is an investigator-led, prospective, randomized, open label, parallel, multi-center study to explore and evaluate the therapeutic effects of Liraglutide, Empagliflozin and Linaglip...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Participants aged ≥40 and ≤75 years, of any gender.
- Type 2 diabetes diagnosed according to the American Diabetes Association criteria
- Mild cognitive impairment diagnosed according to the established criteria
- Cognitive concern from the patient, or an informant or skilled clinicians
- Objective evidence of cognitive impairment: education-adjusted MoCA score ≤ 25 and ≥ 18; or ≥1.0 standard deviation below the mean of age- and education-specific groups on any cognitive subdomain
- Preservation of independence in daily living abilities: Barthel Index score ≥ 60
- Absence of dementia
- Treatment with a stable glucose lowering regimen of metformin monotherapy (≥ 1,000 mg daily) or combination with sulfonylurea/glibenclamide/glycosidase inhibitor/basal insulin over the previous 3 months
- Glycosylated hemoglobin (HbA1c) during screening between ≥7.0% and ≤10.0%
- BMI of ≥ 19 kg/m2
- Education duration of ≥6 years
- Right-handed participants
- Understanding of the research procedures and methods, potential benefits and risks of the trial, and sign written informed consent
- Exclusion criteria
- History of other dementia-related neurological diseases, depression within the past 2 years, developmental disorders, mania, depression, schizophrenia, etc.
- Significant nasal sinusitis, nasal cavity and sinus polyps, cranial or nasopharyngeal tumors and other space-occupying lesions, congenital diseases and trauma of the nose, maxillofacial area, and skull base that affect olfaction. Symptoms of upper respiratory tract infection on the day of MRI examination, including nasal congestion, rhinorrhea, fever, etc.
- Acute metabolic complications such as diabetic ketoacidosis, hyperglycemic hyperosmolar state and hypoglycemic coma within the previous 6 months
- Severe organ dysfunction of heart, liver, kidneys, and thyroid, including unstable angina, myocardial infarction, or grade II and above cardiac insufficiency within 3 months before screening; estimated glomerular filtration rate (eGFR) by CKD-EPI formula \<45 mL/min/1.73 m², alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater exceeding twice the upper limit of normal, hyperthyroidism or uncontrolled hypothyroidism
- History of medullary thyroid carcinoma, pancreatitis, multiple endocrine neoplasia syndrome type 2, recurrent urinary tract infections, severe gastrointestinal diseases or history of gastrointestinal surgery, history of malignant tumors
- With MRI contraindications, such as implanted metal prosthesis, claustrophobia, etc.
- Females who are pregnant, lactating, breast feeding or of child bearing age without effective contraception
- Participated in other clinical trials within the previous 6 months
- Known or suspected allergy to the study drugs
- Received treatment with GLP-1RAs, dual GLP-1R/GCGR agonist, SGLT-2 inhibitors or DPP4 inhibitors in the past 3 months
- Known history of drug or alcohol abuse within the past 6 months
Exclusion
Key Trial Info
Start Date :
October 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2026
Estimated Enrollment :
396 Patients enrolled
Trial Details
Trial ID
NCT05313529
Start Date
October 8 2022
End Date
July 31 2026
Last Update
January 6 2026
Active Locations (5)
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1
Department of Endocrinology, Changzhou No.2 People's Hospital, the Affiliated Hospital of Nanjing Medical University
Changzhou, Jiangsu, China, 213000
2
Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University
Nanjing, Jiangsu, China, 210000
3
Department of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China, 210008
4
Department of Endocrinology, the Affiliated Jiangning Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 211100