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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000042926 |
Receipt No. | 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 | 2021/01/06 |
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 |
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Condition | ||
Condition | Type 2 Diabetes Mellitus | |
Classification by specialty |
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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 |
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Age-upper limit |
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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) 5.Patients who have not administration of drugs for hyperuricemia from at least 6 weeks before the date of consent 6.<45% of total energy from carbohydrate and patients who have not intake barley within 6 weeks before consent |
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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 |
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Target sample size | 10 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | Nakakinen clinic |
Institute | |
Department |
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 |
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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 | Preinitiation | ||||||
Date of protocol fixation |
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Date of IRB |
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Anticipated trial start date |
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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 |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049000 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |