UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012167
Receipt number R000014224
Scientific Title Effects of beta-cryptoxanthin on glucose metabolism (Acute phase)
Date of disclosure of the study information 2013/10/30
Last modified on 2013/10/30 13:35:11

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Basic information

Public title

Effects of beta-cryptoxanthin on glucose metabolism (Acute phase)

Acronym

Acute effect of beta-cryptoxanthin

Scientific Title

Effects of beta-cryptoxanthin on glucose metabolism (Acute phase)

Scientific Title:Acronym

Acute effect of beta-cryptoxanthin

Region

Japan


Condition

Condition

IGT
Type2 diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of the present study was to evaluate the glucose metabolism of beta-cryptoxanthin containing beverages versus placebo in patients with IGT and type 2 diabetes.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Blood glucose fluctuation
M values, MAGE, and blood glucose standard deviation were calculated from CGM

Key secondary outcomes

1.Changes in the physical findings(Body weight/waist circumference/Blood pressure/
Heart rate/The body composition by impedance method)
2.Evaluation of verification and safety of adverse events (hypoglycemia, hyperglycemia, gastrointestinal symptoms)
3.Factors associated with effect of glucose metabolism


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit


Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

beta-cryptoxanthin containing beverages

Interventions/Control_2

placebo

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


 Not applicable

Gender

Male and Female

Key inclusion criteria

1.Impaired glucose tolerance patients and patients with type 2 diabetes
2.purpose education hospitalization
3.Patient capable of glycemic control
4.FPG <400mg/dl on admission and
FPG <150 mg / dl at the start of the test

Key exclusion criteria

1.history of type 1 diabetes or history of ketoacidosis
2.history of hypoglycemia severe symptoms associated with loss of consciousness or coma
3.severe infection, the severe trauma
4. poorly controlled hypertension, systolic blood pressure >160 mmHg, or diastolic blood pressure >100
5.patients with grade 3 or more of the Ministry of Health, Labour and Welfare drug side effects classification serious complication
6.pregnancy or breast feeding
7.inability to participate in the study as assessed by the investigators

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tsuguhito Ota

Organization

Kanazawa University

Division name

Brain/Liver Interface Medicine Research Center

Zip code


Address

13-1 Takara-machi Kanazawa, Japan

TEL

076-265-2863

Email

tota@staff.kanazawa-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tsuguhito Ota

Organization

Kanazawa University Hospital

Division name

Department of Medicine

Zip code


Address

13-1 Takaramachi, Kanazawa, Japan

TEL

076-265-2234

Homepage URL


Email

tota@staff.kanazawa-u.ac.jp


Sponsor or person

Institute

Brain/Liver Interface Medicine Research Center, Japan

Institute

Department

Personal name



Funding Source

Organization

National Agruculture and Food Research Organization

Organization

Division

Category of Funding Organization

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

2013 Year 10 Month 30 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


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

Open public recruiting

Date of protocol fixation

2013 Year 10 Month 03 Day

Date of IRB


Anticipated trial start date

2013 Year 10 Month 15 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 10 Month 30 Day

Last modified on

2013 Year 10 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014224


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name