UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000814 |
|---|---|
| Receipt number | R000000976 |
| Scientific Title | Effects of pioglitazone and metformin on mitochondrial function evaluated with 31P MRS in type 2 DM. |
| Date of disclosure of the study information | 2007/10/01 |
| Last modified on | 2017/09/06 15:01:58 |
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Basic information
Public title
Effects of pioglitazone and metformin on mitochondrial function evaluated with 31P MRS in type 2 DM.
Acronym
31P MRS measurement of mitochondrial function and insulin resistance.
(3M study)
Scientific Title
Effects of pioglitazone and metformin on mitochondrial function evaluated with 31P MRS in type 2 DM.
Scientific Title:Acronym
31P MRS measurement of mitochondrial function and insulin resistance.
(3M study)
Region
| Japan |
Condition
Condition
type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
1. To evaluate the correlation between the severity of insulin resistance and mitochondrial dysfunction of skeletal muscle in type 2 diabetes in Japan. (cross-sectional study)
Using phosphorous-31 magnetic resonance spectroscopy(31P-MRS), we determine mitochondrial function of skeletal muscle by measuring phosphocreatine recovery half time(Pcr half time) immediately after exercise. We compare mitochondrial function with intramyocellular lipid content(IMCL), hepatic lipid content(HLC) measured with 1H-MRS, Glucose Infusion Rate(GIR) calculated by hyperinsulinemic-euglycemic glucose clamp and the amount of several adipocytokines.
2. To study whether insulin sensitizing agents(thiazolidinediones or biguanide) improve mitochondrial function of skeletal muscle, whether improvement of mitochondrial function correlate with the changes of IMCL, GIR, or adipocytokines.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Measurement of mitochondrial function of skeletal muscle before and after 24 weeks treatment with different insulin sensitizers.
Key secondary outcomes
1. Measurement of the amount of visceral fat, IMCL and HLC before and after 24 weeks treatment.
2. Measurement of GIR before and after 24 weeks treatment.
3. Measurement of FPG, IRI, HbA1c, total-cholesterol, triglyceride, HDL-cholesterol, LDL-cholesterol, FFA, adipocytokines before and after 24 weeks treatment.
4. Measurement of body weight and waist before and after 24 weeks treatment.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
pioglitazone (15-30mg/day)
Interventions/Control_2
metformin (750mg/day)
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
type 2 diabetes mellitus Japanese patients not used either thiazolidinediones nor biguanide.
Key exclusion criteria
1. Severe renal dysfunction(serum creatinine>2.0mg/dl)
2. Severe liver dysfunction(AST, ALT>50IU/ml)
3. Severe heart failure
4. History of hypersensitivity to pioglitazone or metformin
5. During the pregnancy or nursing
6. Arteriosclerosis obliterans (ASO) (ABI<0.9)
7. Poor control of plasma glucose (FPG>150mg/dl)
8. Inadequate to entry to this study
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiko Sakaguchi |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine
Zip code
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe 650-0017
TEL
078-382-5861
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhiko Sakaguchi |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine
Zip code
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe 650-0017
TEL
078-382-5861
Homepage URL
kzhkskgc@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Kobe University Graduate School of Medicine
Department of radiology
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
| 2007 | Year | 10 | Month | 01 | 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
| 2007 | Year | 08 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2009 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2007 | Year | 08 | Month | 30 | Day |
Last modified on
| 2017 | Year | 09 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000976
