UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061616 |
|---|---|
| Receipt number | R000070494 |
| Scientific Title | A prospective study on the effects of pharmacological treatment on endothelial function in patients with obesity complicated by hypertension |
| Date of disclosure of the study information | 2026/05/18 |
| Last modified on | 2026/05/18 14:45:27 |
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Basic information
Public title
Prospective study evaluating changes in vascular function after obesity treatment in patients with obesity and hypertension
Acronym
Obesity-FMD Study
Scientific Title
A prospective study on the effects of pharmacological treatment on endothelial function in patients with obesity complicated by hypertension
Scientific Title:Acronym
FMD-Obesity Prospective Study
Region
| Japan |
Condition
Condition
Obesity complicated by hypertension
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To prospectively evaluate the effects of pharmacological treatment with GLP-1 receptor agonists or GLP-1/GIP receptor agonists on flow-mediated dilation (FMD) in patients with obesity complicated by hypertension. In addition, exploratory analyses will be performed to investigate associations with autonomic nervous function (CVRR) and neuroendocrine markers (ACTH and serum cortisol).
Basic objectives2
Others
Basic objectives -Others
Exploratory
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in flow-mediated dilation (FMD) from baseline to 52 weeks after initiation of pharmacological treatment
Key secondary outcomes
Changes in coefficient of variation of R-R intervals (CVRR), ACTH, serum cortisol, body weight, BMI, HbA1c, lipid profile, liver function, renal function, and ABI/CAVI from baseline to 52 weeks after treatment initiation. Exploratory analyses will also be performed to evaluate associations between changes in FMD and changes in CVRR, ACTH, and serum cortisol.
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
1. Patients diagnosed with obesity who are scheduled to initiate treatment with GLP-1 receptor agonists or GLP-1/GIP receptor agonists
2. Patients complicated by hypertension (receiving antihypertensive medication or having outpatient blood pressure of 140/90 mmHg or higher)
3. Patients aged 18 years or older
4. Written informed consent for participation in this study
Key exclusion criteria
1. Pregnant or breastfeeding women
2. Patients considered inappropriate for participation by the investigators
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takanobu |
| Middle name | |
| Last name | Saheki |
Organization
Kagawa University Hospital
Division name
Department of Clinical Laboratory
Zip code
761-0793
Address
Kagawa University Hospital 1750-1 Ikenobe, Miki-cho, Kita-gun,
TEL
087-891-2230
saheki.takanobu@kagawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Takanobu |
| Middle name | |
| Last name | Saheki |
Organization
Kagawa University Hospital
Division name
Department of Clinical Laboratory
Zip code
761-0793
Address
Kagawa University Hospital 1750-1 Ikenobe, Miki-cho, Kita-gun,
TEL
087-891-2230
Homepage URL
saheki.takanobu@kagawa-u.ac.jp
Sponsor or person
Institute
Kagawa University Hospital
Institute
Department
Personal name
Funding Source
Organization
Kagawa University Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Support Center, Kagawa University Hospital
Address
1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa 761-0793, Japan
Tel
087-898-5111
chiken-m@kagawa-u.ac.jp
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
| 2026 | Year | 05 | Month | 18 | 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
| 2026 | Year | 01 | Month | 22 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 27 | Day |
Anticipated trial start date
| 2026 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a single-center prospective observational study in patients with obesity complicated by hypertension. Participants receiving GLP-1 receptor agonists or GLP-1/GIP receptor agonists as part of routine clinical practice will be observed without study-specific therapeutic intervention. Flow-mediated dilation (FMD), coefficient of variation of R-R intervals (CVRR), ACTH, serum cortisol, anthropometric parameters, and metabolic parameters will be evaluated at baseline, 24 weeks, and 52 weeks after treatment initiation.
Management information
Registered date
| 2026 | Year | 05 | Month | 18 | Day |
Last modified on
| 2026 | Year | 05 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070494
