UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042926 |
|---|---|
| Receipt number | R000049000 |
| Scientific Title | Influence of low-carbohydrate diets on serum uric acid in patients with newly diagnosed type 2 diabetes mellitus |
| Date of disclosure of the study information | 2021/01/06 |
| Last modified on | 2022/01/06 10:20:58 |
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Basic information
Public title
Influence of low-carbohydrate diets on serum uric acid in patients with newly diagnosed type 2 diabetes mellitus
Acronym
Influence of low-carbohydrate diets on serum uric acid in patients with newly diagnosed type 2 diabetes mellitus
Scientific Title
Influence of low-carbohydrate diets on serum uric acid in patients with newly diagnosed type 2 diabetes mellitus
Scientific Title:Acronym
Influence of low-carbohydrate diets on serum uric acid in patients with newly diagnosed type 2 diabetes mellitus
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 clarify the efficacy and the safety of nutrition counseling and barley intake on increased serum uric acid levels following low-carbohydrate diets in patients with newly diagnosed type 2 diabetes mellitus.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes of serum uric acid and carbohydrate energy ratio at 12 weeks after barley intake
Key secondary outcomes
Changes of several parameters at 4, 8, and 12 weeks after barley intake as shown below
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.Patients providing written informed consent to participate in the study
2.Aged >=20 years (irrespective of sex)
3.Serum uric acid level >6.0, <10.0 mg/dL at consent
4.A >0.5 mg/dL increase in serum uric acid level at consent compared to before that (2-6 weeks before consent)or serum uric acid level >=7.0 mg/dL both before and at consent
5.Patients who have not administration of drugs for hyperuricemia from at least 6 weeks before the date of consent
6.50% of total energy from carbohydrate and patients who have not intake barley at consent
Key exclusion criteria
1.Type 1 diabetes
2.Patients with severe ketosis, diabetic coma or pre-coma, severe infection, perioperative, or severe trauma
3.Patients with severe renal dysfunction or treated with hemodialysis for end-stage renal disease
4.History of acute coronary syndrome, cerebrovascular disease, myocarditis, contractile pericarditis, or severe valvular disease within 12 weeks before consent
5.Patients with liver dysfunction (AST or ALT >100IU/L) or urolithiasis
6.Diagnosed or suspected malignant tumors (patients who do not have a treatment history of anticancer therapy within 1 year before consent, and have no plan to do so will not be excluded)
7.Pregnant, breast-feeding, or possibly pregnant women
8.Patients treated with SGLT2 inhibitor, losartan, or irbesartan within 6 weeks before consent
9.Patients in the study is judged by the investigator or sub-investigator as inappropriate for any other reason
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Takoeshi |
| Middle name | |
| Last name | Osonoi |
Organization
Nakakinen clinic
Division name
Director
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
Nakakinen clinic
Division name
Department of clinical research
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
Nakakinen clinic
Institute
Department
Personal name
Funding Source
Organization
Hakubaku Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics committee of Nakakinen clinic
Address
745-5 Nakadai, Naka-shi, Ibaraki
Tel
029-353-2800
k-ofuchi@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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 01 | Month | 06 | 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
Terminated
Date of protocol fixation
| 2020 | Year | 11 | Month | 20 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 23 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 18 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
It is reported that low-carbohydrate diets did result in increased in serum uric acid levels in overweight or obese subjects in USA.
Management information
Registered date
| 2021 | Year | 01 | Month | 06 | Day |
Last modified on
| 2022 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049000
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
