Type 2 Diabetes Clinical Trial
Official title:
Pilot Project Evaluation of the DPP-4 Inhibition With Sitagliptin on Calcium and Bone Metabolism in Patients With Type 2 Diabetes Mellitus
Participants will be persons with Type 2 Diabetes who are likely to have increased risk of
bone fractures. The investigators believe this medication will enhance bone turnover.
The investigators will use DXA measurements to evaluate bone density before and after
subjects take the medication.
Type 2 Diabetes Mellitus (T2DM) is associated with an increased risk of bone fractures even
when there is not decreased bone density via DXA measurements. This appears primarily
related to impaired bone quality and abnormal bone architecture. Although the exact
pathophysiologic mechanisms remain unclear, low bone turnover is considered one of the key
defects. Emerging evidence suggests that dipeptidyl peptidase (DPP) inhibition is associated
with improved bone quality and reduction in fracture risk.
While animal studies have shown an improvement in bone mineral density and trabecular
architecture with sitagliptin treatment, no such studies in humans have yet been undertaken.
We are proposing to extend these animal studies with a pilot clinical trial that seeks to
use serum markers of bone turn-over and calcaneal quantitative ultrasound to evaluate the
effect of DPP-4 inhibition on bone metabolism. Our hypothesis is that DPP-4 inhibition with
sitagliptin will enhance bone turn over and quality in persons with T2DM.
This project project seeks to examine the impact of six months of therapy on sitagliptin, a
DPP-4 inhibitor, on bone metabolism and bone quality in subjects with T2DM. The proposed
study is intended to be a pilot investigation for providing preliminary data for submission
of a more definitive national grant proposal with a larger patient population, blinded
randomized control design and high resolution CT imaging of the lumbar spine.
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