UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046336 |
|---|---|
| Receipt number | R000052727 |
| Scientific Title | Effects of postprandial hyperglycemia on vascular endothelial function and pressor response to static handgrip exercise |
| Date of disclosure of the study information | 2021/12/20 |
| Last modified on | 2023/06/12 12:22:09 |
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Basic information
Public title
Effects of postprandial hyperglycemia on vascular endothelial function and pressor response to static handgrip exercise
Acronym
Effects of postprandial hyperglycemia on vascular endothelial function and pressor response to static handgrip exercise
Scientific Title
Effects of postprandial hyperglycemia on vascular endothelial function and pressor response to static handgrip exercise
Scientific Title:Acronym
Effects of postprandial hyperglycemia on vascular endothelial function and pressor response to static handgrip exercise
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Postprandial hyperglycemia/hyperinsulinemia acutely impairs vascular endothelial function (VEF) and exaggerates sympathetic activation, which may augment the pressor response to static handgrip exercise (HG-ex). The purpose of this study was to examine the effects of postprandial hyperglycemia and hyperinsulinemia on VEF in brachial artery and mean arterial pressure (MAP) responses to HG-ex.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
endothelial function, pressor response to static handgrip exercise
Key secondary outcomes
blood glucose, plasma insulin, blood pressure, heart rate
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food | Other |
Interventions/Control_1
Participants consume a high glycemic index breakfast meal at 8:30-9:00, and subsequently rest for 3 hours. Before (baseline) and 1 and 3 hours after consumption of breakfast meal, vascular endothelial function in brachial artery is evaluated using flow mediated dilation (FMD) method by ultrasonography. FMD is calculated as percent change of diameter (%FMD), which is normalized to shear rate area under the curve (AUC) from cuff release to peak dilation (%FMDSRauc). Subsequently, participants perform 30% maximal voluntary contraction static handgrip exercise, followed by postexercise ischemia (PEMI). Blood glucose and plasma insulin levels are measured every 15 or 30 min after consumption of meal and each of area under the curve (AUC) is calculated.
Interventions/Control_2
Participants consume a low glycemic index breakfast meal at 8:30-9:00, and subsequently rest for 3 hours. Before (baseline) and 1 and 3 hours after consumption of breakfast meal, vascular endothelial function in brachial artery is evaluated using flow mediated dilation (FMD) method by ultrasonography. FMD is calculated as percent change of diameter (%FMD), which is normalized to shear rate area under the curve (AUC) from cuff release to peak dilation (%FMDSRauc). Subsequently, participants perform 30% maximal voluntary contraction static handgrip exercise, followed by postexercise ischemia (PEMI). Blood glucose and plasma insulin levels are measured every 15 or 30 min after consumption of meal and each of area under the curve (AUC) is calculated.
Interventions/Control_3
Participants skip a breakfast meal at 8:30-9:00, and subsequently rest for 3 hours. Before (baseline) and 1 and 3 hours after consumption of breakfast meal, vascular endothelial function in brachial artery is evaluated using flow mediated dilation (FMD) method by ultrasonography. FMD is calculated as percent change of diameter (%FMD), which is normalized to shear rate area under the curve (AUC) from cuff release to peak dilation (%FMDSRauc). Subsequently, participants perform 30% maximal voluntary contraction static handgrip exercise, followed by postexercise ischemia (PEMI). Blood glucose and plasma insulin levels are measured every 15 or 30 min after consumption of meal and each of area under the curve (AUC) is calculated.
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
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Age between 20 and 59 years old
2. Not taking any medications and dietary supplements
3. No medical and surgical diseases
4. No smoker
5. A participant who not performed weight changes plus or minus 3 kg in the past three months and who has no intention to weight loss during the study
6. Must not be the participant of others research within the research period (confirm by asking the participants directly and orally when explaining the research content)
7. A participant who can consume the test meal in the study
8. A participant whose menstrual cycle is normal
Key exclusion criteria
1. Not age between 20 and 59 years old
2. A participant who takes medications and dietary supplements
3. A participant who has medical and surgical diseases
4. Smoker
5. A participant who performed weight changes plus or minus 3 kg in the past three months and who has an intention to weight loss during the study
6. A participant who are scheduled to participate to others research.
7. A participant who cannot consume the test meal in the study
8. A participant who is pregnant, suspected of being pregnant, and within 1 year of parturition
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Hideaki |
| Middle name | |
| Last name | Kashima |
Organization
Prefectural University of Hiroshima
Division name
Faculty of Health Sciences
Zip code
734-8558
Address
1-1-71 Ujina-higashi, Minami-ku, Hiroshima
TEL
0822519806
h-kashima@pu-hiroshima.ac.jp
Public contact
Name of contact person
| 1st name | Hideaki |
| Middle name | |
| Last name | Kashima |
Organization
Prefectural University of Hiroshima
Division name
Faculty of Health Sciences
Zip code
734-8558
Address
1-1-71 Ujina-higashi, Minami-ku, Hiroshima
TEL
0822519806
Homepage URL
h-kashima@pu-hiroshima.ac.jp
Sponsor or person
Institute
Prefectural University of Hiroshima
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science KAKENHI
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Prefectural University of Hiroshima
Address
1-1-71 Ujina-higashi, Minami-ku, Hiroshima
Tel
0822519534
kikaku2@pu-hiroshima.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
| 2021 | Year | 12 | Month | 20 | 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
15
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 | 03 | Month | 22 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 22 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 20 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2022 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 12 | Month | 09 | Day |
Last modified on
| 2023 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052727
