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Effect of Pioglitazone on Mitochondrial Function in Muscle and Adipose Tissue in Humans (PIO)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Arizona State University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Takeda Pharmaceuticals North America, Inc.
Information provided by:
Arizona State University
ClinicalTrials.gov Identifier:
NCT01165190
First received: July 16, 2010
Last updated: NA
Last verified: July 2010
History: No changes posted
  Purpose

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.


Condition
Type II Diabetes Mellitus

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of Pioglitazone on Mitochondrial Function in Muscle and Adipose Tissue in Humans

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Arizona State University:

Biospecimen Retention:   Samples Without DNA

Blood, urine, and adipose tissue will be collected.


Estimated Enrollment: 20
Study Start Date: May 2008
Groups/Cohorts
Pioglitazone group

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Both men and women, ages 18-65, any ethnicity.

Criteria

Inclusion Criteria:

  1. Subjects must be able to communicate meaningfully with the investigator and must be legally competent to provide written informed consent.
  2. 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.
  3. Subjects must range in age from 18-65.

  4. Subjects must have the following laboratory values:

    • 2-hour OGTT plasma glucose 140-250 mg/dl
    • Hematocrit ≥ 35 vol%
    • 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

Exclusion Criteria:

  1. 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.
  2. 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
  3. History of peripheral vascular disease (history of claudication)
  4. History of pulmonary disease (dyspnea on exertion of one flight or less; abnormal breath sounds on auscultation).
  5. History of peripheral edema
  6. Uncontrolled hypertension with systolic BP>160 mmHg, diastolic BP>100 mmHg
  7. Resting heart rate >100 beats/min
  8. Autonomic neuropathy
  9. Heavy alcohol consumption (> 2 drinks/day)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01165190

Contacts
Contact: Christian Meyer, MD (480) 965-2473 Christian.Meyer@asu.edu

Locations
United States, Arizona
Clinical Research Unit Recruiting
550 East Orange Street, Arizona, United States, 85287
Contact: Christian Meyer, MD     (480) 965-2473     Christian.Meyer@asu.edu    
Sponsors and Collaborators
Arizona State University
Takeda Pharmaceuticals North America, Inc.
  More Information

No publications provided

Responsible Party: Christian Meyer, M.D., Arizona State University
ClinicalTrials.gov Identifier: NCT01165190     History of Changes
Other Study ID Numbers: 07-012A
Study First Received: July 16, 2010
Last Updated: July 16, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Pioglitazone
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013