Acute Effects of Canagliflozin, a Sodium Glucose Co-Transporter 2 (SGLT2) Inhibitor on Bone Metabolism in Healthy Volunteers
Abstract
Background:
\- Canagliflozin (sold as InvokanaTM) is a new medicine for diabetes. But it might increase the bone fracture risk in people with diabetes.
Objective:
\- To see if Invokana has negative side effects on bone health.
Eligibility:
\- Healthy men ages 18 45.
Design:
* Participants will be screened with a medical history, physical exam, and blood tests. A nutritionist will discuss their dietary history and the study dietary requirements. Participants will get a food diary to record what they eat and drink on 3 separate days.
* Participants will have a DEXA scan x-ray test of bone health. Participants will lie still on a table while a small camera passes over the body.
* Participants will have 2 stays in the clinic. They will be 1 week apart and each last 6 overnights starting on a Sunday.
* Before each stay, participants will:
* Pick up food each day for 7 days. They will get breakfast, lunch, dinner, and snacks. They must eat only the food provided during these times.
* Collect their urine twice.
* During the stays, participants will:
* Be evaluated by a doctor and have blood drawn.
* On each Monday, participants will:
* Skip breakfast
* At about 8 a.m. take a placebo pill in one stay, the study drug in the other stay.
* Drink 6 ounces of water every 2 hours for 4 hours.
* An intravenous (IV) catheter will be inserted into an arm. Blood will be drawn every 2 hours from 8 a.m. until noon.
* Get lunch.
* Have blood testing again at 8pm and midnight.
* Repeat the…
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 67 participants or records.
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