NCT02444364

Effects of DPP-4 Inhibition on Calcium and Bone Metabolism in Type 2 Diabetes Mellitus

Pilot Project Evaluation of the DPP-4 Inhibition With Sitagliptin on Calcium and Bone Metabolism in Patients With Type 2 Diabetes Mellitus

• Status: Withdrawn
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Missouri-Columbia · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	Sitagliptin	Subjects will receive 90 tablets of 100mg sitagliptin

Timeline

• Start date: 2015-05-01
• Primary completion: 2016-01-01
• Completion: 2016-01-01
• First posted: 2015-05-14
• Last updated: 2017-06-01

Locations

1 site across 1 country: United States