UMIN-CTR Clinical Trial

Public title

Effect of oral glucose on hemodynamics after exercise

Acronym

Effect of oral glucose on hemodynamics after exercise

Scientific Title

Effect of oral glucose on hemodynamics after exercise

Scientific Title:Acronym

Effect of oral glucose on hemodynamics after exercise

Region

Japan

Condition

hypertensive patient, hypotensive patient

Classification by specialty

Medicine in general

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Exercise and meal ingestion independently have been shown to induce a reduction of blood pressure by the change of regional hemodynamics in some individuals. Post-exercise hypotension (PEH) lasts approximately two hours in healthy individuals and last beyond half a day in hypertensive patients. Previous studies showed that PEH arises from increased systemic vascular conductance via exercise and non-exercise muscle vasodilation not splanchnic and renal vasodilation. Postprandial hypotension (PPT) occurs frequently in elderly, disorders of the autonomic nervous system. PPH was induced by the vasodilation in gastrointestinal tract. However, this phenomenon was not observed in young healthy subject by vasoconstriction in other vessel (e.g. skeletal muscles) except for organ associated with the digestion and absorption. It has been shown that the vasodilation of skeletal muscles last after dynamic exercise. To determine if the combined effects of exercise and food had a cumulative blood pressure reduction effect on PEH. We evaluate the effects of 75g glucose drink on the systemic and regional hemodynamics response after dynamic exercise.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable

Primary outcomes

We evaluate the effects of 75g glucose drink on the systemic and regional hemodynamics response after dynamic exercise. Trial 1 (glucose ingestion): Subjects are positioned supine for 30 min before drink ingestion. The glucose drink (75g glucose in 225ml) is consumed within 1 min in raised upper body, and then subjects are repositioned supine for 120 min.
Trial 2 (exercise): Subjects are positioned supine for 30 min before exercise. The exercise consiste of a 60-min period of upright cycling at 50% of resting heart rate reserve on 60 rpm. Immediately after the exercise period the subjects are positioned supine for a further 120 min.
Trial 3 (glucose ingestion after exercise): Subjects are positioned supine for 30 min before exercise. The exercise consiste of a 60-min period of upright cycling at 50% resting heart rate reserve on 60 rpm. Immediately after the exercise period the subjects are positioned supine for a further 160 min. The glucose drink (75g glucose in 225ml) is ingested at 40 min after exercise. Blood pressure, heart rate, stroke volume and blood flows of popliteal artery, brachial artery and superior mesenteric artery are measured during the rest, post glucose and post exercise by every 10 min.

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Behavior,custom

Interventions/Control_1

Trial 1 (glucose ingestion): Subjects are positioned supine for 30 min before drink ingestion. The glucose drink (75g glucose in 225ml) is consumed within 1 min in raised upper body, and then subjects are repositioned supine for 120 min.
Trial 2 (exercise): Subjects are positioned supine for 30 min before exercise. The exercise consiste of a 60-min period of upright cycling at 50% resting heart rate reserve on 60 rpm. Immediately after the exercise period the subjects are positioned supine for a further 120 min.
Trial 3 (glucose ingestion after exercise): Subjects are positioned supine for 30 min before exercise. The exercise consiste of a 60-min period of upright cycling at 50% resting heart rate reserve on 60 rpm. Immediately after the exercise period the subjects are positioned supine for a further 160 min. The glucose drink (75g glucose in 225ml) is ingested at 40 min after exercise. Each protocol is undertaken on a separate day with at least 7 days intervening between trials. The order of three protocols is randomly assigned among subjects.

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

Age-lower limit

18

years-old

<=

Age-upper limit

30

years-old

>=

Gender

Male and Female

Key inclusion criteria

Subjects are healthy, normotensive, non-smoking, sedentary with normal activity; they perform no regular endurance training and participate in < 2 h of aerobic exercise per week.

Key exclusion criteria

Non-suitable subjects are disease, smoking, athlete with high activity; they perform regular endurance training and participate in > 2 h of aerobic exercise per week.

Target sample size

10

Name of lead principal investigator

1st name
Middle name
Last name	Masako Yamaoka Endo

Organization

Prefectural University of Hiroshima

Division name

Health Sciences

Zip code

Address

1-1-71 Ujina-higashi, Minami-ku, Hiroshima

TEL

082-251-9770

Email

Name of contact person

1st name
Middle name
Last name	Masako Yamaoka Endo

Organization

Prefectural University of Hiroshima

Division name

Health Sciences

Zip code

Address

1-1-71 Ujina-higashi, Minami-ku,

TEL

082-251-9770

Homepage URL

Email

Institute

Laboratory of Exercise Science and Physiology, Department of Health Sciences, Prefectural University of Hiroshima

Institute

Department

Personal name

Organization

Prefectural University of Hiroshima

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2012

Year

02

Month

16

Day

URL releasing protocol

Publication of results

Published

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

Recruitment status

Main results already published

Date of protocol fixation

2011

Year

12

Month

25

Day

Date of IRB

Anticipated trial start date

2012

Year

01

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2012

Year

02

Month

16

Day

Last modified on

2016

Year

03

Month

16

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007503