"TAKE TIME" Pioglitazone Reverses Defects in Mitochondrial Biogenesis in Patients With T2DM

Completed · Phase 4 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 2

In brief

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.

Key facts

Study ID

NCT00402012

Run by

Pennington Biomedical Research Center

People needed

24

Starts

2006-11-01

Expected to finish

2007-12-01

Last updated by the study team

2015-12-18

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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

Where it is running

• Pennington Biomedical Research Center — Baton Rouge, Louisiana, United States

Full record on ClinicalTrials.gov

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