Status:
COMPLETED
"TAKE TIME" Pioglitazone Reverses Defects in Mitochondrial Biogenesis in Patients With T2DM
Lead Sponsor:
Pennington Biomedical Research Center
Collaborating Sponsors:
Takeda Pharmaceuticals North America, Inc.
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
This study is designed to look at the effect of Pioglitazone treatment on the body's ability to burn food in order to produce energy.
Detailed Description
Skeletal muscle mitochondrial defects are a sine qua non of insulin resistance in patients with T2DM. Pioglitazone decreases free fatty acid levels and restores mitochondria number in adipose tissue w...
Eligibility Criteria
Inclusion
- Men and women aged 18-70 with Type 2 diabetes as defined by:
- Fasting plasma glucose \> 126 mg/dL at entry
- Or a two-hour OGTT glucose \> 200mg/dL
- Or current treatment with one or two oral anti-diabetic drugs, except TZD
- Or currently using insulin
- Fasting plasma glucose \< 200mg/dL at entry
- BMI \>27.0 and \<45.0kg/m2
- Adequate contraception for women (including, but not limited to: oral contraception, hysterectomy, tubal ligation, or post-menopausal as defined by \> 6 months without a menstrual cycle and FSH \> 40 mIU/ml).
Exclusion
- Significant renal, cardiac, liver, lung, or neurological disease (controlled hypertension is acceptable if baseline bp \< 140/90 on medications).
- Prior use of other thiazolidinediones (rosiglitazone \[AVANDIATM\], pioglitazone \[ACTOSTM\])
- Use of drugs known to affect energy metabolism or body weight: including, but not limited to: orlistat, sibutramine, ephedrine, phenylpropanolamine, corticosterone, etc.
- Pregnancy
- Alcohol or other drug abuse
- Unwilling or unable to abstain from caffeine (48h) and tobacco (24h) prior to metabolic rate measurements
- Increased liver function tests at baseline (AST/ALT/GGT/or alkaline phosphatase greater than 2.5 times the upper limit of normal)
- Metal objects that would interfere with the measurement of body composition /MRS such as implanted rods, surgical clips, etc.
- HbA1C of \> 10%.
- NYHA class III/IV CHF is an exclusionary cardiac condition.
- history of deep vein thrombosis (DVT) or pulmonary embolism (PE)
- varicose veins
- major surgery on the abdomen, pelvis, or lower extremities within previous 3 months
- cancer (active malignancy with or without concurrent chemotherapy)
- rheumatoid disease
- bypass graft in limb
- known genetic factor (Factor V Leiden, etc) or hypercoagulable state
- diagnosed peripheral arterial or vascular disease, or intermittent claudication
- family history of primary DVT or PE (pulmonary embolism)
- peripheral neuropathy
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00402012
Start Date
November 1 2006
End Date
December 1 2007
Last Update
December 18 2015
Active Locations (1)
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1
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808