UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of Helicobacter pylori eradication on insulin resistance in patients with pre-diabetes and type 2 diabetes
Title of the study (Brief title)	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	Shinobu Satoh
Organization	Chigasaki Municipal Hospital
Division name	Department of Endocrinology and Metabolism
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	Yoshinobu Kondo
Organization	Chigasaki Municipal Hospital
Division name	Department of Endocrinology and Metabolism
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2012 Year 03 Month 31 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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