UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017434 |
|---|---|
| Receipt number | R000019086 |
| Scientific Title | Effects of meal-sequences on postprandial glucose levels, incretin secretion and gastric emptying: Evaluation in individuals with type 2 diabetes and healthy control. |
| Date of disclosure of the study information | 2015/05/06 |
| Last modified on | 2016/02/10 23:04:41 |
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Basic information
Public title
Effects of meal-sequences on postprandial glucose levels, incretin secretion and gastric emptying: Evaluation in individuals with type 2 diabetes and healthy control.
Acronym
Effects of meal-sequences on postprandial glucose levels, incretin secretion and gastric emptying: Evaluation in individuals with type 2 diabetes and healthy control.
Scientific Title
Effects of meal-sequences on postprandial glucose levels, incretin secretion and gastric emptying: Evaluation in individuals with type 2 diabetes and healthy control.
Scientific Title:Acronym
Effects of meal-sequences on postprandial glucose levels, incretin secretion and gastric emptying: Evaluation in individuals with type 2 diabetes and healthy control.
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate effects of meal-sequences on postprandial glucose excursions, incretin secretions and gastric emptying
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Glucose levels, their area under the curve, theri glucose levels, and their standard deviations before and after ingestion of steamed rice.
Key secondary outcomes
1) levels of insulin, glucagon, GLP-1, GIP and their area under the curve before and after ingestion of steamed rice.
2) time required for 50% ofsteamed rice to exit the stomach (t1/2).
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
A) Rice before boiled mackerel, B) boiled mackerel before rice, C) grilled beef
Interventions/Control_2
A) boiled mackerel before rice, B) Rice before boiled mackerel, C) grilled beef
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
| 30 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Untreated individuals with type 2 diabetes who full fills following inclusion criteria and healthy volunteers
1) HbA1c 9.0% or less
2) BMI 35 or less
3) Indivisuals on diet and exercise therapies
Key exclusion criteria
Following individuals are excluded from the study
1)Indivisuals with any adjustments of any drugs during the study period
2)Individuals with moderate or severe renal impairment
3)Individuals on peritoneal dialysis or hemodialysis
4)Individuals with severe hepatic dysfunction
5)Individuals with shock, heart failure, myocardial infarct, pulmonary embolism, sever pulmonary dysfunction, hypoxemia
6)Individuals with excessive alcohol intake 7)Individuals with dehydration, and dehydration-causing severe GI symptoms including diarrhea and vomit
8)Individuals with severe ketosis, or coma.
9)Individuals with severe infection, in the perioperative period or with serious injury
10)Individuals with Hb <13.0 mg/dL (male) and Hb <12.5 mg/dL (female)
11)Individuals allergic to mackerels
12)Individuals with a history of GI operation
13) Individuals pregnant or possibly pregnant
14) Individuals found ineligible as a study patient according to the discretion of the investigator or sub-investigators
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Daisuke Yabe |
Organization
Kansai Electric Power Hospital
Division name
Center for Diabetes, Endocrinology and Metabolism
Zip code
Address
2-1-7 Fukushima, Fukushima-ku, Osaka, Japan
TEL
06-6458-5821
ydaisuke-kyoto@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daisuke Yabe |
Organization
Kansai Electric Power Hospital
Division name
Center for Diabetes, Endocrinology and Metabolism
Zip code
Address
2-1-7 Fukushima, Fukushima-ku, Osaka, Japan
TEL
06-6458-5821
Homepage URL
ydaisuke-kyoto@umin.ac.jp
Sponsor or person
Institute
Kansai Electric Power Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Association for Diabetes Education and Care
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
Address
Tel
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
| 2015 | Year | 05 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/pubmed/26704625
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
Completed
Date of protocol fixation
| 2014 | Year | 02 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 02 | Month | 14 | Day |
Last follow-up date
| 2014 | Year | 04 | Month | 02 | Day |
Date of closure to data entry
| 2014 | Year | 05 | Month | 14 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 05 | Month | 06 | Day |
Last modified on
| 2016 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019086
