UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057522 |
|---|---|
| Receipt number | R000065643 |
| Scientific Title | Investigation of the mechanism of improvement of renal function before and after metabolic surgery |
| Date of disclosure of the study information | 2025/04/07 |
| Last modified on | 2026/02/05 06:04:09 |
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Basic information
Public title
Investigation of the mechanism of improvement of renal function before and after metabolic surgery
Acronym
Investigation of the mechanism of improvement of renal function before and after metabolic surgery
Scientific Title
Investigation of the mechanism of improvement of renal function before and after metabolic surgery
Scientific Title:Acronym
Investigation of the mechanism of improvement of renal function before and after metabolic surgery
Region
| Japan |
Condition
Condition
Adiposity
Classification by specialty
| Surgery in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Renal function assessment, changes in perirenal lipid content and metabolomic analysis of plasma and urine will be observed in detail to reveal new mechanisms of renal function improvement with dynamic metabolic improvement by metabolic surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Urinary biomarkers that correlate with the efficacy of metabolic surgery and improvement in hypertension, type 2 diabetes, and CKD will be evaluated and studied. In addition, postoperative weight including BMI, status of obesity related disorders, medication status (diabetes medications, antihypertensive medications, etc.), glucose tolerance test, blood tests (blood count, biochemistry, blood sugar, etc.), respiratory function tests, all-night polysomnography, contrast enhanced (plain) CT of the thoracoabdominal pelvic region, histopathological examination (liver tissue), and postoperative urine Metabolomic changes will be evaluated for regulator changes involved in fibrosis of adipocyte tissue and changes in perirenal adipose tissue volume, using multiomics analysis of plasma and urine.
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who are scheduled to undergo MS and have given their consent to participate in this study.
Patients with MS should have the following conditions
1) Severely obese patients with a Body Mass Index (BMI) of 35 kg/m2 or higher and one or more of the following complications: type 2 diabetes, hypertension, dyslipidemia, sleep apnea syndrome, or metabolic disfunction associated steatotic liver disease including metabolic dysfunction associated fatty liver disease
2) Obese patients with BMI of 32 - 34.9 kg/m2 and type 2 diabetes mellitus with HbA1c of 8.0% or higher (NGSP: National Glycohemogulobin Standardization Program value), or hypertension which is difficult to control for systolic blood pressure of 160 mmHg or lower even with antihypertensive drug therapy for 6 months or longer, dyslipidemia
which is difficult to manage for LDL cholesterol 140 mg/dL or lower or non-HDL cholesterol 170 mg/dL or lower even with statins or other drugs for at least 6 months. Sleep apnea syndrome is limited to patients who are (AHI Apnea Hyponea Index > 30) or fatty liver disease related to metabolic dysfunction, metabolic disfunction associated steatotic liver disease including metabolic dysfunction associated fatty liver disease of two or more of the following
Key exclusion criteria
not applicable
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Sasaki |
Organization
Iwate Medical University School of Medicine
Division name
Department of Surgery
Zip code
028-3609
Address
2-1-1 Idai-dori, Yahaba-cho, Shiwa-gun, Iwate
TEL
019-613-7111
sakira@iwate-med.ac.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Umemura |
Organization
Iwate Medical University School of Medicine
Division name
Department of Surgery
Zip code
028-3609
Address
2-1-1 Idai-dori, Yahaba-cho, Shiwa-gun, Iwate
TEL
019-613-7111
Homepage URL
aumemura@iwate-med.ac.jp
Sponsor or person
Institute
Iwate Medical University
Institute
Department
Personal name
Akira Sasaki
Funding Source
Organization
Iwate Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Iwate Medical University Ethics Review Committee
Address
2-1-1 Idai-dori, Yahaba-cho, Shiwa-gun, Iwate
Tel
019-613-7111
ysuto.iwate.076@gmail.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
| 2025 | Year | 04 | Month | 07 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 03 | Month | 21 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 21 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 21 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observations items
Medical record information
Age, gender, medical history, drug administration history (whether or not antipsychotic or sleeping medication is taken), smoking history, alcohol consumption habits, weight, body mass index (BMI), weight loss, excess weight loss, total weight loss will be evaluated.
Results of abdominal ultrasound and abdominal CT scan performed as usual medical examination will be used to evaluate visceral fat mass, subcutaneous fat mass and perirenal fat mass.
75g OGTT to evaluate insulin levels, blood glucose levels, GLP-1 measurements, insulinogenic index, disposition Index. Pre- and postoperative changes in respiratory function are evaluated with respiratory function tests. Sleep apnea syndrome will be evaluated by PSG. Carotid artery stenosis is evaluated by head MRI and carotid artery echocardiography.
Blood tests: Creatinine, eGFR, cystatin C, AST, ALT, gamma-GTP, TG, TC, LDL, MDA-LDL, HbA1c, C-peptide, renin, aldosterone, angiotensin I, high sensitivity CRP, TNF-alpha, ferritin, hyaluronic acid, type IV collagen 7S, MDA-LDL, blood ketone fractions, PAI-1, and leptin are evaluated.
Metabolome analysis using urinalysis and urine samples and high depth proteosome analysis using plasma
In addition to the usual medical care described above, urine albumin content, urine protein content and 24-hour creatinine clearance will be measured by urinalysis. In addition, metabolome analysis will be used to include HIF-1alpha and TGF-beta related to fat fibrosis. Additional laboratory tests will be added as needed.
Management information
Registered date
| 2025 | Year | 04 | Month | 04 | Day |
Last modified on
| 2026 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065643
