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Insulin Sensitizers on Mitochondrial ATP Production and Mitochondrial ATP Production and Mitochondrial Protein Synthesis on Insulin Resistant Type 2 Diabetes and Obesity
This study is currently recruiting participants.
Verified by Mayo Clinic, March 2007
First Received: February 26, 2007   Last Updated: March 5, 2007   History of Changes
Sponsors and Collaborators: Mayo Clinic
National Institutes of Health (NIH)
Information provided by: Mayo Clinic
ClinicalTrials.gov Identifier: NCT00443755
  Purpose

An association between insulin resistance and mitochondrial dysfunction has been observed in aging, T2D, and in offspring of patients with T2D. It remains to be determined whether pharmacological agents that enhance insulin sensitivity improve muscle mitochondrial function. If these insulin sensitizers improve muscle mitochondrial functions, there are potential therapeutic opportunities to use these drugs to improve mitochondrial dysfunction such as sarcopenia of aging or obesity. Our previous studies demonstrated that insulin stimulates muscle mitochondrial PS and ATP production. It is therefore likely that increasing insulin action stimulates mitochondrial PS and ATP production. If so, these results argue against mitochondrial dysfunction as a cause for insulin resistance. The secondary measurements will demonstrate the underlying mechanism ? whether changes occur at the level of intracellular signaling, transcription or translation. Furthermore, changes in hepatic fat infiltration and endogenous glucose release will be assessed.


Condition Intervention
Type 2 Diabetes
Insulin Resistance
Drug: metformin
Drug: pioglitazone

MedlinePlus related topics: Diabetes Obesity
Drug Information available for: Insulin Pioglitazone Pioglitazone hydrochloride Metformin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title: The Effect of Insulin Sensitizers on Mitochondrial ATP Production and Mitochondrial ATP Production and Mitochondrial Protein Synthesis on Insulin Resistant Type 2 Diabetic and Obese People

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • mitochondrial ATP production and synthesis

Estimated Enrollment: 30
Study Start Date: July 2006
  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • We will study 30 patients with Type 2 Diabetes or impaired fasting glucose (15 men & 15 women) who are > 20 years old.
  • Only patients who use lifestyle modification to manage their diabetes and are not on any oral hypoglycemic agents or insulin will be included.
  • We will enroll subjects who have fasting glucose concentration greater than 100 mg/dl on two consecutive occasions and have a BMI between 27-36 kg/m2.

Exclusion Criteria:

  • We will exclude patients whose blood glucose is above 180 mg/dl. This will avoid the need to perform home glucose monitoring and the potential of unblinding the study by the volunteers.
  • Patients taking oral hypoglycemic agents or insulin would be excluded.
  • Any diseases such as active cardiovascular disease, liver diseases, kidney failure (males with serum creatinine >= 1.5mg/dl, females >=1.4 mg/dl), active endocrinopathies, debilitating chronic disease, anemia, symptoms of undiagnosed illness, history of alcoholism (alcohol use > 4oz/day) or substance abuse, chronic neurological diseases including Alzheimer's disease, stroke, etc, myopathies or any other active disease that may potentially affect the outcome measures.
  • Patients on medicines such as beta blockers, corticosteroids, tricyclics, benzodiazepines, opiates, barbiturates, anticoagulants and any other drugs or preparations that may affect mitochondrial function will be excluded.
  • People allergic to any of the class of drug such as lidocaine will also be excluded.
  • People with pacemakers, certain aneurysm clips and claustrophobia will also be excluded as they cannot undergo magnetic resonance imaging.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00443755

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: K. Sreekumaran Nair     507-255-2415     nair.sree@mayo.edu    
Principal Investigator: K. Sreekumaran Nair, M.D., Ph.D.            
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: K. Sreekumaran Nair, M.D., Ph.D. Mayo Clinic
  More Information

No publications provided

Study ID Numbers: 05-004002, R01 DK41973
Study First Received: February 26, 2007
Last Updated: March 5, 2007
ClinicalTrials.gov Identifier: NCT00443755     History of Changes
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Obesity
Metabolic Diseases
Pioglitazone
Metformin
Diabetes Mellitus
Endocrine System Diseases
Insulin
Hyperinsulinism
Hypoglycemic Agents
Diabetes Mellitus, Type 2
Insulin Resistance
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

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

ClinicalTrials.gov processed this record on May 07, 2009