Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
GlaxoSmithKline
With
Population Health Research Institute
Age
50–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Men or women with: a) newly detected type 2 diabetes based on a fasting plasma glucose greater than or equal to 7.0 mmol/l (126 mg/dL) or a 2 hour plasma glucose (FPG) greater than or equal to 11.1 mmol/l (200 mg/dL) on an oral glucose tolerance test, or b) a history of type 2 diabetes
Hemoglobin A1c (A1C) 6.5-9.5% inclusive (for assays with upper limit of normal of 6%) within one month of screening
Age ≥ 50 years and evidence of vascular disease defined as ≥1of:
* prior myocardial infarction
* prior stroke
* coronary, carotid or peripheral artery revascularization ≥ 4 years earlier
* previous documented myocardial ischemia on either an exercise stress test or on any cardiac imaging, or previous unstable angina with ECG changes or cardiac enzyme elevation OR
Age ≥ 55 years and evidence of subclinical vascular disease defined as ≥1 of:
* microalbuminuria or proteinuria
* history of treated or untreated hypertension with left ventricular hypertrophy by electrocardiogram (ECG) or echocardiogram
* 50% stenosis on any imaging of coronary, carotid or lower extremity arteries
* ankle/brachial index \<0.9 OR
Age ≥ 60 years and at least 2 of the following cardiovascular disease risk factors:
* current tobacco use
* LDL-c ≥3.4 mmol/L (130 mg/dL) or on a lipid lowering medication
* HDL-c \< 1.0 mmol/L (40 mg/dL) for men and \< 1.3 mmol/L (50 mg/dL) for women or triglycerides ≥ 2.3 mmol/L (200 mg/dL)
* BP lowering medication use or untreated SBP ≥ 140 mmHg or DBP ≥ 95 mmHg
* Waist to hip ratio \> 1.0 for men and \> 0.8 for women
On no insulin and on less than or equal to 2 anti-diabetes drugs where at least one drug is at or below the half-maximal dose (as indicated in the MOP) with stable dosing for 10 weeks prior to screening
You may not be if
Type 1 diabetes
Current need for insulin treatment
Symptomatic hyperglycemia requiring immediate therapy in the judgment of the physician
An acute cardiovascular event within 30 days prior to randomization
Symptomatic heart failure (i.e. New York Heart Association class II or higher) or any episode of previous pulmonary edema or known ejection fraction \< 0.4 or current use of loop diuretics
Any fracture within the past 1 year
Currently planned coronary, carotid or peripheral artery revascularization or cardiac valve surgery
Coronary, carotid or peripheral artery revascularization within the 4 years prior to screening in the absence of angina, MI, or stroke in the intervening period
End stage renal disease requiring renal replacement therapy
Receiving drug therapy to treat liver disease
A diagnosis of cancer (other than superficial squamous, basal cell skin cancer, or adequately treated cervical carcinoma in situ) in the past 3 years or current treatment for the active cancer (other than prophylactic)
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level \> 2.5 times the upper limit of normal
A prior heart transplant or awaiting a heart transplant
Previous or current hypercalcemia, hyperparathyroidism, osteomalacia or other contraindication for vitamin D therapy
Regular use of or indication for greater than 400IU of vitamin D daily
Clinically or medically unstable with expected survival \< 1 year
Unwillingness to permit sites to contact their primary physicians to communicate information about the study and the participant's data
Any other factor likely to limit protocol compliance or reporting of adverse events
Inability to discontinue a TZD (if taking one) in the judgement of the physician/investigator
Contraindications to or history of hypersensitivity to the investigational products
History of renal stones within the past 2 years
Participation in another clinical trial of an investigational agent
Clareo Health | Thiazolidinedione Intervention With Vitamin D Evaluation
