Type 2 diabetes mild cognitive impairment
Conditions
Interventions
DPP-4 inhibitors and Sulfonylureas or Meglitinides will switch to Dulaglutide 0.75mg once weekly at the timing of obtained agreement in this study.
Treatment at obtaining consent is continued.
Sponsors
Ogawa Red Cross Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Type 2 diabetes 2)Patients with HbA1c 8.0% and below 3)Patients with mild cognitive impairment (MoCA-J score is from 18 to 25 and/or MMSE score is from 24 to 27) 4)Patients who are treated with DPP-4 inhibitors and Sulfonylureas or Meglitinides 5)Patient age is 65 years old or more at the timing of obtained agreement in this study 6)Patients having no dosing history of GLP-1 receptor agonist within 6 months 7)Patients whose medicine did not change during the last 3 months 8)Patients with BMI of 22.0 kg/m2 or higher
Exclusion criteria
Exclusion criteria: 1)Type 1 diabetes or suspicion of Type 1 diabetes 2)Dosing of insulin injection 3)Suspicion of dementia (MoCA-J score is 17 and below and/or MMSE score is 23 and below) 4)Dosing of weekly DPP-4 inhibitor 5)Severe ketosis, diabetic coma or precoma 6)Clinical history of pancreatitis 7)Severe infectious disease, pre/post-surgery or serious trauma 8)Severe hepatic dysfunction 9)Pituitary or adrenal gland dysfunction 10)Status of dystrophy/starvation, irregular meal intake, dietary intake deficiency or hyposthenia 11)Excessive alcohol intake 12)Clinical history of allergy or hypersensitivity to GLP-1 receptor agonists 13)Pregnant/ possible pregnant, breastfeeding 14)Psychiatric disorder 15)Inappropriate patients for study participation judged by principal or clinical investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Japanese version of Montreal Cognitive Assessment (MoCA-J) and Mini Mental State Examination (MMSE) | — |
Secondary
| Measure | Time frame |
|---|---|
| Group comparison of the following parameters before and after treatment 1)Physical examination Body weight, BMI, blood pressure, pulse rate and grip strength 2)Presence of symptomatic hypoglycemia 3)Hematology WBC, RBC, Hb, Ht, PLT 4)Biochemistry AST, ALT, LDH, gamma-GTP, TC, HDL-C, TG, LDL-C, Cyc-C, eGFRcyc, Cr, BUN, UA, Alb, Na, K, Cl, HbA1c, fasting blood glucose, fasting serum insulin, fasting serum C-peptide 5)vitamin B12, folic acid 6)TSH, FT3, FT4 7)Inflammatory markers IL-6, TNF-alpha, high sensitivity CRP 8)BNP 9)Urinalysis urine Cr, urine sodium, urine potassium, urine protein, urine albumin 10)Physiological test electrocardiogram (including CVR-R), ABI/PWV 11)Imaging study carotid duplex, head MRI, head MRA, VSRAD, cerebral blood flow scintigraphy 12)Adverse event | — |
Countries
Japan
Contacts
Public ContactTakashi Sumita
Ogawa Red Cross Hospital Department of Internal Medicine
Outcome results
None listed