UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040102 |
|---|---|
| Receipt number | R000045719 |
| Scientific Title | Research on support for patients with type 2 diabetes by collaboration between nutritionists and pharmacists in pharmacies |
| Date of disclosure of the study information | 2020/05/20 |
| Last modified on | 2022/10/11 19:10:53 |
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Basic information
Public title
Research on support for patients with type 2 diabetes by collaboration between nutritionists and pharmacists in pharmacies
Acronym
Research on support for patients with type 2 diabetes by collaboration between nutritionists and pharmacists in pharmacies
Scientific Title
Research on support for patients with type 2 diabetes by collaboration between nutritionists and pharmacists in pharmacies
Scientific Title:Acronym
Research on support for patients with type 2 diabetes by collaboration between nutritionists and pharmacists in pharmacies
Region
| Japan |
Condition
Condition
type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the effect of dieticians and pharmacists working together to improve dietary support for outpatients with type 2 diabetes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
HbA1c
Key secondary outcomes
LDL-c, TG, BP, the tendency of Henshoku, Satisfaction of the pharmacy
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Nutritionist and pharmacist jointly support lifestyle improvement for patients with type 2 diabetes
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Being a type 2 diabetic patient
2. 20-80 years old
3. No serious complications (proliferative retinopathy, gangrene of lower limbs due to neuropathy, dialysis due to diabetic nephropathy)
4. No abnormalities in mastication and swallowing functions
5. Have not received other private eating habit improvement support services
6. Does not impose any restrictions on food (eg vegetarianism) for religious or other reasons
7. The use of questionnaires and instructional devices is possible
8. No experience of mental or nervous system disease
9. No malignancy
Key exclusion criteria
1. Anyone who does not meet any of the selection criteria
2. Those who did not give consent to participate in the study
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Mitsuko |
| Middle name | |
| Last name | Onda |
Organization
Osaka University of Pharmaceutical Sciences
Division name
Laboratory of social and Administrative pharmacies
Zip code
569-1094
Address
4-20-1,Nasahara, Takatsuki, Osaka
TEL
0726901024
shoji@gly.oups.ac.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Shoji |
Organization
Osaka University of Pharmaceutical Sciences
Division name
laboratory of Social and Administrative Pharmacies
Zip code
569-1094
Address
4-20-1, Nasahara, Takatsuki, Osaka
TEL
0726901024
Homepage URL
shoji@gly.oups.ac.jp
Sponsor or person
Institute
Osaka University of Pharmaceutical Sciences
Institute
Department
Personal name
Funding Source
Organization
policy-based medical services foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka University of Pharmaceutical Sciences, Research Ethics Committee
Address
4-20-1, Nasahara, Takatsuki, Osaka
Tel
0726901103
kenkyus@gly.oups.ac.jp
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
| 2020 | Year | 05 | Month | 20 | Day |
Related information
URL releasing protocol
https://doi.org/10.18549/PharmPract.2022.2.2657
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.18549/PharmPract.2022.2.2657
Number of participants that the trial has enrolled
9
Results
The mean (SD) of HbA1c, the primary endpoint, was 7.3 (1.0) at baseline and decreased to 6.6 (0.8) after 6 months (p=0.028, r=0.72). Also, the HDL-c increased from 55.0 (14.8) to 63.1 (10.1) (p=0.110, r=0.51), and the DMDSES score increased from 51.7 (8.3) to 60.2 (8.4) (p=0.025, r=0.79), the satisfaction score increased from 24.0 (4.0) to 26.1 (3.3) (p=0.161, r=0.51). Moderate decreases were also observed in LDL-c (p=0.235, r=0.47) and TG (p=0.368, r=0.37).
Results date posted
| 2022 | Year | 10 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The mean age was 70.1 years, and 62.5% of the patients were male. Half of the patients had complications of hypertension or dyslipidemia. The physical activity level was 1 in 75.0% and 3 in 25.0%. None of the patients smoked, and 37.5% drank alcohol.
Participant flow
Nine patients were recruited for the study at three pharmacies. One person dropped out during the intervention period. An analysis was conducted on the 8 patients who completed the intervention period.
Adverse events
No adverse events attributable to the interventions in this study have been identified.
Outcome measures
The primary outcome was the change in Hemoglobin A1c (HbA1c). The secondary outcomes were low-density lipoprotein-cholesterol (LDL-c), Triglyceride (TG), high-density lipoprotein-cholesterol (HDL-c), degree of unbalanced diet, degree of dietary self-management and satisfaction with pharmacy services.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2020 | Year | 04 | Month | 06 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 04 | Month | 08 | Day |
Last modified on
| 2022 | Year | 10 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045719
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| Registered date | File name |
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