UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030840 |
|---|---|
| Receipt number | R000035208 |
| Scientific Title | Observation of using GLP-1 receptor agonist for wellness of brain activity in type 2 diabetes patients with mild cognitive impairment |
| Date of disclosure of the study information | 2018/01/16 |
| Last modified on | 2018/01/16 19:49:22 |
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Basic information
Public title
Observation of using GLP-1 receptor agonist for wellness of brain activity in type 2 diabetes patients with mild cognitive impairment
Acronym
Observation of using GLP-1 receptor Agonist for Wellness of brain Activity in type 2 diabetes patients with Mild Cognitive Impairment / OGAWA-MCI Study
Scientific Title
Observation of using GLP-1 receptor agonist for wellness of brain activity in type 2 diabetes patients with mild cognitive impairment
Scientific Title:Acronym
Observation of using GLP-1 receptor Agonist for Wellness of brain Activity in type 2 diabetes patients with Mild Cognitive Impairment / OGAWA-MCI Study
Region
| Japan |
Condition
Condition
Type 2 diabetes
mild cognitive impairment
Classification by specialty
| Medicine in general | Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to elucidate the
efficacy of GLP-1 receptor agonist, dulaglutide, to cognitive function in type 2 diabetes patients with mild cognitive impairment.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in Japanese version of Montreal Cognitive Assessment (MoCA-J) and Mini Mental State Examination (MMSE)
Key secondary outcomes
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
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
DPP-4 inhibitors and Sulfonylureas or Meglitinides will switch to Dulaglutide 0.75mg once weekly at the timing of obtained agreement in this study.
Interventions/Control_2
Treatment at obtaining consent is continued.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key 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
Key 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
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Sumita |
Organization
Ogawa Red Cross Hospital
Division name
Department of Internal Medicine
Zip code
Address
1525 Ogawa, Ogawa-machi, Hiki-gun, Saitama Japan
TEL
0493-72-2333
sumi.jp@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Sumita |
Organization
Ogawa Red Cross Hospital
Division name
Department of Internal Medicine
Zip code
Address
1525 Ogawa, Ogawa-machi, Hiki-gun, Saitama Japan
TEL
0493-72-2333
Homepage URL
sumi.jp@gmail.com
Sponsor or person
Institute
Ogawa Red Cross Hospital
Institute
Department
Personal name
Funding Source
Organization
Ogawa Red Cross Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 01 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 12 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 01 | Month | 16 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 16 | Day |
Last modified on
| 2018 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035208
