UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Intensity and timing of exercise for controling postprandial hyperglycemia in patients with type 2 diabetes
Title of the study (Brief title)	Exercise protcol for postprandial hyperglycemia
Region	Japan

Condition
Condition	Type 2 Diabetes
Classification by specialty	Medicine in general Endocrinology and Metabolism Adult
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	The inhibitory effect of postprandial blood glucose level due to the difference in the exercise intensity for type 2 diabetes.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Comparison the area under the concentration-time curve of blood glucose concentration for 4 hours between exercise intensity.
Key secondary outcomes	1. Correlation between the blood glucose value AUC for 4 hours after lunch and selenoprotein P concentration , general findings , and laboratory values. 2. Comparison between the blood glucose value AUC for 4 hours after lunch and exercise start time. 3. Relation between the blood glucose value AUC for 4 hours after lunch and gene expression.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Day1: a 60-minute bicycle ergometer exercise at 25% HRMax from postprandial 1 hour Day2: a 30-minute bicycle ergometer exercise at 50% HRMax from postprandial 1 hour Day3: a 20-minute bicycle ergometer exercise at 75% HRMax from postprandial 1 hour Day4: a 30-minute bicycle ergometer exercise at 50% HRMax from postprandial 2 hour Day5: no exercise
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	20 years-old <=
Age-upper limit	75 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Type 2 Diabetes 2. Patients with exercise therapy has been formulated in diabetes education hospitalization.
Key exclusion criteria	Poorly controlled hypertension None type 2 diabetes Insulin treatment B2 blocker use patient Positive anti-GAD antibodies Kidny disease(stage 3 or later) Pregnant or lactating women Inability to participate in the study as assessed by the investigators.
Target sample size	20

Research contact person
Name of lead principal investigator	Toshinari Takamura
Organization	Kanazawa University Graduate School of Medical Sciences
Division name	Comprehensive Metabology, Kanazawa University Graduate School of Medical Sciences
Address	13-1 Takara-machi, Kanazawa, Ishikawa
TEL	076-265-2234
Email	ttakamura@m-kanazawa.jp

Public contact
Name of contact person	Yumie Takeshita
Organization	Kanazawa university hospital
Division name	Department of Disease Control and Homeostasis
Address	13-1 Takara-machi, Kanazawa, Ishikawa
TEL	076-265-2234
Homepage URL
Email	takeshita@m-kanazawa.jp

Sponsor
Institute	Kanazawa university hospital Department of Disease Control and Homeostasis
Institute
Department

Funding Source
Organization	Kanazawa university hospital Department of Disease Control and Homeostasis
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	YES
Study ID_1	2070-1
Org. issuing International ID_1	Kanazawa university
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	金沢大学附属病院　恒常性制御学 小松ソフィア病院　内分泌代謝内科

Other administrative information
Date of disclosure of the study information	2016 Year 10 Month 24 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 02 Month 27 Day
Anticipated trial start date	2016 Year 02 Month 27 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 10 Month 24 Day
Last modified on	2016 Year 10 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028238