UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007811 |
|---|---|
| Receipt number | 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 12:43:39 |
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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
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
bleu-ciel@umin.ac.jp
Sponsor or person
Institute
Chigasaki Municipal Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009009
