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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000007811
Receipt No. R000009009
Scientific Title Effect of Helicobacter pylori eradication on insulin resistance in patients with pre-diabetes and type 2 diabetes
Date of disclosure of the study information 2012/04/23
Last modified on 2017/04/26

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Basic information
Public title Effect of Helicobacter pylori eradication
on insulin resistance in patients with pre-diabetes and type 2 diabetes
Acronym HELPER Study
Scientific Title Effect of Helicobacter pylori eradication
on insulin resistance in patients with pre-diabetes and type 2 diabetes
Scientific Title:Acronym HELPER Study
Region
Japan

Condition
Condition Impaired glucose tolerance
Impaired fasting glucose
Type 2 diabetes
Helicobacter pylori infection
Classification by specialty
Gastroenterology Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to investigate the effects of Helicobacter pylori (HP) eradication on insulin resistance.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Insulin resistance (fasting serum insulin levels and homeostasis model assessment of insulin resistance (HOMA-IR)) at before and after HP eradication.
Key secondary outcomes HbA1c, lipid profile, C reactive protein, body weight, body mass index and waist circumference at before and after HP eradication.

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 Treatment
Type of intervention
Medicine
Interventions/Control_1 HP eradication
(Lansoprazole 60mg/day, AMPC 1500mg/day and CAM 800mg/day for 7days)
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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1) Patients with pre-diabetes or type 2 diabetes.
2) Patients with fasting plasma glucose <= 140mg/dl or HbA1c <= 8.0%(NGSP).
3) Patients with gastric or duodenal ulcer scar and HP infection.
Key exclusion criteria 1)Patients who initiated or changed antidiabetic drugs within 3 months prior to the study entry.
2)Patients who initiated or changed antidyslipidemic drugs within 3 months prior to the study entry.
3)Patients who initiated or changed antiinflammatory drugs within 3 months prior to the study entry.
4)Patients receiving insulin therapy.
5)Patients with gastric or duodenal ulcer in the acute phase.
6)Patients with severe infection or severe trauma.
7)Patients with malignancy.
8)Patients during pregnancy or lactation.
9)Patients with severe liver dysfunction.
10)Patients with severe renal insufficiency.
11)Patients receiving steroid therapy.
12)Patients who were allergic to HP eradication drugs.
13)Patients incapable of informed consent.
14)Patients determined to be inappropriate by physician.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinobu Satoh
Organization Chigasaki Municipal Hospital
Division name Department of Endocrinology and Metabolism
Zip code
Address 5-15-1 Honson Chigasaki-shi Kanagawa, Japan
TEL 0467-52-1111
Email shinobu@medical.email.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshinobu Kondo
Organization Chigasaki Municipal Hospital
Division name Department of Endocrinology and Metabolism
Zip code
Address 5-15-1 Honson Chigasaki-shi Kanagawa, Japan
TEL 0467-52-1111
Homepage URL
Email bleu-ciel@umin.ac.jp

Sponsor
Institute Chigasaki Municipal Hospital
Institute
Department

Funding Source
Organization None
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
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 茅ヶ崎市立病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2012 Year 04 Month 23 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 Terminated
Date of protocol fixation
2012 Year 03 Month 31 Day
Date of IRB
Anticipated trial start date
2012 Year 05 Month 01 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
2012 Year 04 Month 22 Day
Last modified on
2017 Year 04 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009009

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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