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

Email

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


Email

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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name