UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047034 |
|---|---|
| Receipt number | R000053661 |
| Scientific Title | The changes from first visit in dietary intake by means of food frequency questionnaire in treatment-naive patients with type 2 diabetes |
| Date of disclosure of the study information | 2022/02/28 |
| Last modified on | 2022/02/28 16:32:37 |
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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
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
k-ofuchi@kensei-kai.com
Sponsor or person
Institute
Naka Kinen Clinic
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053661
