UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002772 |
|---|---|
| Receipt number | 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 16:29:57 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
Sponsor or person
Institute
NHO Ehime National Hospital, The department of cardiology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003371
