UMIN-CTR Clinical Trial

Basic information
Public title	The changes from first visit in dietary intake by means of food frequency questionnaire in treatment-naive patients with type 2 diabetes
Acronym	The changes from first visit in dietary intake by means of food frequency questionnaire in treatment-naive patients with type 2 diabetes
Scientific Title	The changes from first visit in dietary intake by means of food frequency questionnaire in treatment-naive patients with type 2 diabetes
Scientific Title:Acronym	The changes from first visit in dietary intake by means of food frequency questionnaire in treatment-naive patients with type 2 diabetes
Region	Japan

Condition
Condition	Type 2 Diabetes Mellitus
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To retrospectively assess the changes from first visit in dietary intake by means of food frequency questionnaire in treatment-naive patients with type 2 diabetes
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Changes from first visit in total energy intake and intake of three macronutrients (carbohydrate, protein, and fat)
Key secondary outcomes	1.Changes in HbA1c, body mass index and antidiabetic drugs 2.Changes in the ratio of three macronutrients 3.Changes in the ratio of main nutrients 4.Changes in serum uric acid and triglyceride, and the relationship between their parameters and total energy intake or intake of three macronutrients

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1.Treatment-naive patients with type 2 diabetes 2.Aged >=20 years (irrespective of sex) 3.Patients who have assessment of 1-week food frequency questionnaire at least 3 times from first visit
Key exclusion criteria	1.Patients in the study is judged by the investigator or sub-investigator as inappropriate for any other reason
Target sample size	13

Research contact person
Name of lead principal investigator	1st name Takeshi Middle name Last name Osonoi
Organization	Naka Kinen Clinic
Division name	department of internal medicine
Zip code	311-0113
Address	745-5 Nakadai, Naka-shi, Ibaraki
TEL	029-353-2800
Email	t-osonoi@kensei-kai.com

Public contact
Name of contact person	1st name Kensuke Middle name Last name Ofuchi
Organization	Naka Kinen Clinic
Division name	Department of clinical research laboratory
Zip code	311-0113
Address	745-5 Nakadai, Naka-shi, Ibaraki
TEL	029-353-2800
Homepage URL
Email	k-ofuchi@kensei-kai.com

Sponsor
Institute	Naka Kinen Clinic
Institute
Department

Funding Source
Organization	Hakubaku Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	the ethics review committee of the Naka Kinen Clinic
Address	745-5 Nakadai, Naka-shi, Ibaraki
Tel	029-353-2800
Email	t-osonoi@kensei-kai.com

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	那珂記念クリニック（茨城県）

Other administrative information
Date of disclosure of the study information	2022 Year 02 Month 28 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	13
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	Completed
Date of protocol fixation	2021 Year 10 Month 18 Day
Date of IRB	2021 Year 10 Month 27 Day
Anticipated trial start date	2021 Year 10 Month 27 Day
Last follow-up date	2022 Year 01 Month 31 Day
Date of closure to data entry	2022 Year 02 Month 04 Day
Date trial data considered complete	2022 Year 02 Month 10 Day
Date analysis concluded	2022 Year 03 Month 18 Day

Other
Other related information	Dietary intake in Japanese outpatients with type 2 diabetes: 2-year follow up study.

Management information
Registered date	2022 Year 02 Month 28 Day
Last modified on	2022 Year 02 Month 28 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053661