UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040785
Receipt number R000046571
Scientific Title Fecal excretion of FDG by metformin in FDG-PET
Date of disclosure of the study information 2020/06/16
Last modified on 2023/04/17 14:17:15

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Basic information

Public title

Fecal excretion of FDG by metformin in FDG-PET

Acronym

Fecal excretion of FDG by metformin in FDG-PET

Scientific Title

Fecal excretion of FDG by metformin in FDG-PET

Scientific Title:Acronym

Fecal excretion of FDG by metformin in FDG-PET

Region

Japan


Condition

Condition

type 2 diabetes mellitus

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To prove that 18F-FDG is excreted in feces in patients with type 2 diabetes taking metformin

Basic objectives2

Others

Basic objectives -Others

Fecal FDG excretion of metformin in FDG-PET

Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Fecal FDG excretion of metformin in FDG-PET

Key secondary outcomes



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

Diagnosis

Type of intervention

Medicine

Interventions/Control_1

Inducing Defecation with laxative

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) Adult. Regardless of gender
2) Those who have 18F-FDG accumulated visually in the intestinal tract after the descending colon by FDG-PET/CT test.

Key exclusion criteria

1) Gastrointestinal cancer
2) Stubborn constipation
3) Inflammatory bowel disease
4) Patients with intestinal bleeding, inflammation in the abdominal cavity or perforation or risk of perforation of the intestinal tract.
5) Nausea, vomiting or severe abdominal pain
6) Patients just after lower gastrointestinal surgery
7) Patients with ischemic heart disease
8) People with general weakness

Target sample size

10


Research contact person

Name of lead principal investigator

1st name Mitsuhiro
Middle name
Last name Nakazaki

Organization

Public interest incorporated association,Kagoshima Kyousaikai,Nanpuh Hospital

Division name

Diabetes/Endocrinology

Zip code

892-8512

Address

14-3 Nagatacho, Kagoshima City, Kagoshima Prefecture, Japan

TEL

0992269111

Email

m-nakazaki@nanpuh.or.jp


Public contact

Name of contact person

1st name Shuko
Middle name
Last name Minami

Organization

Public interest incorporated association,Kagoshima Kyousaikai,Nanpuh Hospital

Division name

Clinical Research Support Office

Zip code

892-8512

Address

14-3 Nagata-cho,, Kagoshima City, Kagoshima Prefecture, Japan

TEL

0998052663

Homepage URL


Email

crc-kenkyu@nanpuh.or.jp


Sponsor or person

Institute

Public interest incorporated association,Kagoshima Kyousaikai,Nanpuh Hospital

Institute

Department

Personal name



Funding Source

Organization

Public interest incorporated association,Kagoshima Kyousaikai,Nanpuh Hospital

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

Public interest incorporated association,Kagoshima Kyousaikai,Nanpuh Hospital

Address

14-3 Nagata-cho, Kagoshima City, Kagoshima Prefecture, Japan

Tel

0992269111

Email

crc-kenkyu@nanpuh.or.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 06 Month 16 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

1

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 01 Month 10 Day

Date of IRB

2020 Year 01 Month 10 Day

Anticipated trial start date

2020 Year 01 Month 10 Day

Last follow-up date

2023 Year 03 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 06 Month 16 Day

Last modified on

2023 Year 04 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046571


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name