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

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pennington Biomedical Research Center
• Collaborator: Takeda Pharmaceuticals North America, Inc.
• Treatments: Pioglitazone

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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