Type II Diabetes MellitusPIONCT01165190
Effect of Pioglitazone on Mitochondrial Function in Muscle and Adipose Tissue in Humans
An observational study of Type II Diabetes Mellitus, run by Arizona State University at 2 sites in United States.
Trial summary
Mitochondrial dysfunction in skeletal muscle results in decreased muscle fatty acid oxidation, leading to conversion of fatty acids into triglycerides and its accumulation inside the muscle tissue. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type II Diabetes Mellitus
- What is being tested?
- pioglitazone
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2008to May 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Both men and women, ages 18-65, any ethnicity.
Who may be able to join
- Subjects must be able to communicate meaningfully with the investigator and must be legally competent to provide written informed consent.
- Subjects may be of either sex with age as described in each protocol. Female subjects must be non-lactating and will be eligible only if they have a negative pregnancy test throughout the study period.
- Subjects must range in age from 18-65.
- Subjects must have the following laboratory values:
- 2-hour OGTT plasma glucose 140-250 mg/dl
- Hematocrit ≥ 35 vol%
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- Serum creatinine ≤ 1.6 mg/dl
- AST (SGOT) < 2.5 times upper limit of normal
- ALT (SGPT) < 2.5 times upper limit of normal
- PT, PTT within the normal range
Who cannot join
- Subjects must not be receiving any medications with known effects on glucose tolerance unless the subject has been on stable dose of such agents for the past three months before entry into the study. Subjects taking systemic glucocorticoids will be excluded. Subjects may be taking a stable dose of estrogens or other hormonal replacement therapy, if the subject has been on these agents for the prior three months.
- History of clinically significant heart disease, including ischemic heart disease (New York Heart Classification greater than grade II; more than non-specific ST-T wave changes on the EKG) and congestive heart failure
- History of peripheral vascular disease (history of claudication)
- History of pulmonary disease (dyspnea on exertion of one flight or less; abnormal breath sounds on auscultation).
- History of peripheral edema
- Uncontrolled hypertension with systolic BP>160 mmHg, diastolic BP>100 mmHg
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- Resting heart rate >100 beats/min
- Autonomic neuropathy
- Heavy alcohol consumption (> 2 drinks/day)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Clinical Research Unit
Tempe, Arizona, 85287
Study site
Tempe, Arizona
About this study
Mitochondrial dysfunction in skeletal muscle results in decreased muscle fatty acid oxidation, leading to conversion of fatty acids into triglycerides and its accumulation inside the muscle tissue. Moreover, in adipose tissue mitochondrial dysfunction results in decreased fatty acid oxidation and triglyceride synthesis, leading to increased circulating fatty acid concentrations, which in turn also leads to lipid accumulation inside muscle tissue. Lipid accumulation inside muscle tissue interferes with the insulin signaling pathway and causes insulin resistance. Mitochondrial dysfunction in both tissues has therefore been proposed to play an important role in insulin resistance in humans.
Pioglitazone, a thiazolidinedione, is an FDA approved medication for the treatment of type 2 diabetes. It improves muscle insulin sensitivity at least in part by lowering intramuscular lipid concentrations but the mechanism by which this occurs is unclear. In the present study, we shall therefore test the hypothesis that pioglitazone improves mitochondrial function in muscle and adipose tissue in humans who are insulin resistant.
- Conditions
- Type II Diabetes Mellitus
- Being tested
- pioglitazone
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pioglitazoneOther
| Study group | Role | What they receive |
|---|---|---|
| Pioglitazone group | Not described Receives: Other: pioglitazone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distribution of adipocyte mitochondria
Measured: 3 months
Secondary outcomes (2)
number of adipocyte proteins
Measured: 3 months
number of mitochondrial proteins
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2010 (estimated)
- Study startMay 2008
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type II Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Arizona State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Collaborators
- Takeda
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01165190
- Sponsor's protocol ID
- 07-012A
- Acronym
- PIO
- Status last verified
- Aug 2024
- First submitted
- 16 Jul 2010
- Last updated
- 13 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Xie X, Sinha S, Yi Z, Langlais PR, Madan M, Bowen BP, Willis W, Meyer C. Role of adipocyte mitochondria in inflammation, lipemia and insulin sensitivity in humans: effects of pioglitazone treatment. Int J Obes (Lond). 2017 Aug 14:10.1038/ijo.2017.192. doi: 10.1038/ijo.2017.192. Online ahead of print.
PubMed 29087390
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pioglitazone on Mitochondrial Function in Muscle and Adipose Tissue in Humans
- ClinicalTrials.gov ID
- NCT01165190
- Acronym / sponsor ID
- PIO / 07-012A
- Conditions
- Type II Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Collaborators
- Takeda
- Study start
- May 2008 (actual)
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 19 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Mitochondrial dysfunction in skeletal muscle results in decreased muscle fatty acid oxidation, leading to conversion of fatty acids into triglycerides and its accumulation inside the muscle tissue. Moreover, in adipose tissue mitochondrial dysfunction results in decreased fatty acid oxidation and triglyceride synthesis, leading to increased circulating fatty acid concentrations, which in turn also leads to lipid accumulation inside muscle tissue. Lipid accumulation inside muscle tissue interferes with the insulin signaling pathway and causes insulin resistance. Mitochondrial dysfunction in both tissues has therefore been proposed to play an important role in insulin resistance in humans.
Pioglitazone, a thiazolidinedione, is an FDA approved medication for the treatment of type 2 diabetes. It improves muscle insulin sensitivity at least in part by lowering intramuscular lipid concentrations but the mechanism by which this occurs is unclear. In the present study, we shall therefore test the hypothesis that pioglitazone improves mitochondrial function in muscle and adipose tissue in humans who are insulin resistant.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pioglitazone group | – | Other: pioglitazone |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Both men and women, ages 18-65, any ethnicity.
Key inclusion criteria (10 listed)
- Subjects must be able to communicate meaningfully with the investigator and must be legally competent to provide written informed consent.
- Subjects may be of either sex with age as described in each protocol. Female subjects must be non-lactating and will be eligible only if they have a negative pregnancy test throughout the study period.
- Subjects must range in age from 18-65.
- Subjects must have the following laboratory values:
Key exclusion criteria (9 listed)
- Subjects must not be receiving any medications with known effects on glucose tolerance unless the subject has been on stable dose of such agents for the past three months before entry into the study. Subjects taking systemic glucocorticoids will be excluded. Subjects may be taking a stable dose of estrogens or other hormonal replacement therapy, if the subject has been on these agents for the prior three months.
- History of clinically significant heart disease, including ischemic heart disease (New York Heart Classification greater than grade II; more than non-specific ST-T wave changes on the EKG) and congestive heart failure
- History of peripheral vascular disease (history of claudication)
- History of pulmonary disease (dyspnea on exertion of one flight or less; abnormal breath sounds on auscultation).
- History of peripheral edema
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pioglitazone | Other | Pioglitazone group |
Primary outcome
Distribution of adipocyte mitochondria
Time frame: 3 months
2 secondary outcomes
number of adipocyte proteins
Time frame: 3 months
number of mitochondrial proteins
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
- Results publication: PubMed 29087390Xie X, Sinha S, Yi Z, Langlais PR, Madan M, Bowen BP, Willis W, Meyer C. Role of adipocyte mitochondria in inflammation, lipemia and insulin sensitivity in humans: effects of pioglitazone treatment. Int J Obes (Lond). 2017 Aug 14:10.1038/ijo.2017.192. doi: 10.1038/ijo.2017.192. Online ahead of print.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type II Diabetes Mellitus, run by Arizona State University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distribution of adipocyte mitochondria (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01165190, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2024.