UMIN-CTR Clinical Trial

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
Email	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
Email	shoji@gly.oups.ac.jp

Sponsor
Institute	Osaka University of Pharmaceutical Sciences
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000045719