UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042053
Receipt number R000047995
Scientific Title Exploratory clinical trial of clamp OGL (clamp with oral glucose load) in patients with type 2 diabetes
Date of disclosure of the study information 2020/10/08
Last modified on 2023/03/01 18:13:41

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Basic information

Public title

clamp OGL study for type 2 diabetes

Acronym

clamp OGL study

Scientific Title

Exploratory clinical trial of clamp OGL (clamp with oral glucose load) in patients with type 2 diabetes

Scientific Title:Acronym

Exploratory clinical trial of clamp OGL for type 2 diabetes

Region

Japan


Condition

Condition

patients with type 2 diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Determine the appropriate condition settings for the clamp OGL

Basic objectives2

Others

Basic objectives -Others

Evaluate hepatic glucose uptake, insulin secretion, and insulin sensitivity

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

hepatic glucose uptake

Key secondary outcomes

insulin secretion
insulin sensitivity


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

Prevention

Type of intervention

Other

Interventions/Control_1

Carry out clamp OGL

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


Not applicable

Gender

Male and Female

Key inclusion criteria

(1) Patients with type 2 diabetes
(2) Age more than 20 years old
(3) Fasting blood glucose level below 130 mg/dL

Key exclusion criteria

(1) Type 1 diabetes
(2) Pancreatic diabetes or pancreatic disease
(3) Post gastrectomy
(4) Insulin antibody
(5) Allergy to insulin
(6) Severe renal dysfunction
(7) Severe liver dysfunction
(8) Severe heart disease
(9) Drug user that affect glucose metabolism
(10) Pregnancy
(11) Mental disease

Target sample size

10


Research contact person

Name of lead principal investigator

1st name Kazuhiko
Middle name
Last name Sakaguchi

Organization

Kobe university

Division name

Department of Diabetes and Endocrinology

Zip code

650-0017

Address

7-5-2, Kusunoki-Cho, Chuo-ku, Kobe

TEL

078-382-5861

Email

kzhkskgc@med.kobe-u.ac.jp


Public contact

Name of contact person

1st name Kazuhiko
Middle name
Last name Sakaguchi

Organization

Kobe university

Division name

Department of Diabetes and endocrinology

Zip code

650-0017

Address

7-5-2, Kusunoki-Cho, Chuo-ku, Kobe

TEL

078-382-5861

Homepage URL


Email

kzhkskgc@med.kobe-u.ac.jp


Sponsor or person

Institute

Kobe university

Institute

Department

Personal name



Funding Source

Organization

Donation

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethics committee of Kobe university

Address

7-5-1, Kusunokicho, Chuo-ku, Kobe

Tel

0784125107

Email

kainyu@med.kobe-u.ac.jp


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

2020 Year 10 Month 08 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

Completed

Date of protocol fixation

2020 Year 10 Month 08 Day

Date of IRB

2021 Year 01 Month 25 Day

Anticipated trial start date

2020 Year 12 Month 15 Day

Last follow-up date

2022 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 10 Month 08 Day

Last modified on

2023 Year 03 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047995


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name