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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000002772
Receipt No. R000003371
Scientific Title The effects of pioglitazone on postprandial glucose and lipid metabolism and vascular function
Date of disclosure of the study information 2009/11/17
Last modified on 2009/11/17

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Basic information
Public title The effects of pioglitazone on postprandial glucose and lipid metabolism and vascular function
Acronym The effects of pioglitazone on postprandial metabolism and vascular function
Scientific Title The effects of pioglitazone on postprandial glucose and lipid metabolism and vascular function
Scientific Title:Acronym The effects of pioglitazone on postprandial metabolism and vascular function
Region
Japan

Condition
Condition Diabetes mellitus
Classification by specialty
Medicine in general Cardiology Endocrinology and Metabolism
Chest surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate chronic pioglitazone administration on postprandial vascular function and changes in central blood pressure as well as postprandial gulcose and lipid metabolism.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Improvement of postprandial glucose and lipid parameters.
Postprandial changes in arterial stiffness (augmentation index of radial artery) and central blood pressure.
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 Treatment
Type of intervention
Medicine
Interventions/Control_1 Oral administration of Pioglitazone (30mg) for about six months or more.
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
30 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria Patients with type 2 diabetes mellitus
Key exclusion criteria Patients with poorly controled type 2 diabetes mellitus
Patients under insulin therapy
Patients with frequent arrythmia
Patients with renal or liver dysfunction
Patients with malignant or collagen disease
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Jun-ichi Funada
Organization NHO Ehime National Hospital
Division name The department of cardiology
Zip code
Address 366 Yokogawara, Toon, Ehime 791-0281
TEL 089-964-2411
Email

Public contact
Name of contact person
1st name
Middle name
Last name Jun-ichi Funada
Organization NHO Ehime National Hospital
Division name The department of cardiology
Zip code
Address 366 Yokogawara, Toon, Ehime 791-0281
TEL 089-964-2411
Homepage URL
Email

Sponsor
Institute NHO Ehime National Hospital, The department of cardiology
Institute
Department

Funding Source
Organization Omron Healthcare Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
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

Other administrative information
Date of disclosure of the study information
2009 Year 11 Month 17 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
The part of results were presented at the 73rd annual meeting of Japanese circulation society.
Title
The Effects of Pioglitazone on Postprandial Central Blood Pressure Regulation in Patients with Type 2 Diabetes Mellitus

Abstract
Background: We demonstrated blunted central blood pressure (CBP) response in
postprandial state, possibly relevant to decreased nitric oxide (NO) bioavailability and activated oxidative stress due to insulin resistance, in patients with metabolic syndrome. On the other hand, little is known about the effects of improving insulin sensitivity in vivo on postprandial state. 
Methods: 18 consecutive patients with type 2 diabetes mellitus (T2DM) were enrolled this investigation. CBPs were assessed by augmentation index of radial artery using HEM-9000 AI (Omron Healthcare, Kyoto, Japan) during fasting 
state, 60 and 120 min after meal intake (Calorie mate 500kcal), and same protocol was repeated 6 months after pioglitazone treatment. 
Results: Both HOMA index and total insulin secretion during meal loading were significantly lowered by pioglitazone treatment. The sum of CBPs reduction 60 and 120 min after meal loading was also enlarged from 19 to 33 (P<0.05) by pioglitazone treatment despite no significant change in fasting CBP.  The degree of CBP reduction and serum insulin level 120 min after meal loading showed a positive significant relationship (r=0.504, P<0.05) after treatment.  Conclusion: Chronic treatment with pioglitazone shows a decline in postprandial CBP levels in T2DM.  This indicate the possibility of administrating pioglitazone to suppress atherosclerotic progression by increasing NO bioavailability and diminishing oxidative stress especially in postprandial state.
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 Enrolling by invitation
Date of protocol fixation
2007 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2007 Year 08 Month 01 Day
Last follow-up date
2010 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 11 Month 17 Day
Last modified on
2009 Year 11 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003371

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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