None listed
Conditions
Brief summary
Type 2 diabetes mellitus (T2DM) is a common disease that is associated with an increased risk of bone fracture. Recent evidence suggests that pioglitazone, a drug commonly used to treat T2DM by improving the effectiveness of action of the hormone insulin, may increase the risk of bone fracture, by decreasing the activity of bone-forming cells and thereby bone density. At present, little is known about the actions of pioglitazone on bone in humans. Our study is designed to determine the mechanism, magnitude and reversibility of the effects of pioglitazone on blood markers of bone metabolism and bone density in subjects with T2DM. Some evidence suggests that pioglitazone may increase the risk of heart failure, although it may also decrease the risk of heart attack and stroke. We intend to perform blood and ultrasound measurements of heart function in the subjects who participate in our study. The results of the study will assist T2DM patients and their doctors in decisions around use of pioglitazone, the need for bone and/or heart monitoring in patients taking pioglitazone, and use of treatments to prevent bone loss in patients taking pioglitazone.
Interventions
Pioglitazone 30mg per oral daily for 12 months
Sponsors
Andrew Grey
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Type 2 diabetes mellitus (T2DM), as defined by fasting blood glucose > 7mmol/L and/or serum glucose > 11mmol/L 2h after ingesting 75g oral glucose. - impaired glucose tolerance, as defined by fasting blood glucose < 6-7 mmol/L and/or serum glucose 7.8-11mmol/L 2h after ingesting 75g oral glucose
Exclusion criteria
Medical Conditions - subjects with type 2 diabetes mellitus (T2DM) deemed to require early glitazone treatment and meeting Pharmac criteria for funded supply - renal impairment (estimated glomerular filtration rate < 30ml/min). - congestive heart failure, New York Heart Association Grade 2 or higher - clinical liver disease. - untreated thyroid dysfunction. - concurrent major systemic illness, including malignancy. - metabolic bone diseases, or serum alkaline phosphatase (ALP) > 2x normal limit. - primary hyperparathyroidism. - Bone mineral density (BMD) T score < -2.0 at total hip or spine - previous fragility fracture (forearm, humerus, hip, vertebra) - body weight >120kg 2.2.2 Medications - use of oral glucocorticoid drugs equivalent to an average dose of prednisone = 2.5 mg/day in the preceding 12 months - current or past use of bisphosphonate therapy - use of hormone replacement therapy within the last 12 months - use of other medication known to alter bone metabolism - current use of thiazolidinediones Insulin use is not an exclusion criterion, but insulin dose should be stable (+/- 20%) for 3 months before enrolment.
Outcome results
None listed