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Ichiro Horie
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ORCiD: https://orcid.org/0000-0003-3430-5796
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Background Elderly patients with type 2 diabetes mellitus (T2DM) have an increased risk of bone fracture independent of their bone mineral density (BMD), which is explained mainly by the deteriorated bone quality in T2DM compared to non-diabetic adults. Sodium-glucose co-transporter (SGLT) 2 inhibitors have been studied in several trials in T2DM, and the Canagliflozin Cardiovascular Assessment Study showed an increased fracture risk related to treatment with the SGLT2 inhibitor canagliflozin, although no evidence of increased fracture risk with treatment with other SGLT2 inhibitors has been reported. The mechanism of the difference in the fracture risk between the SGLT2 inhibitors is unknown, but the differences among the SGLT2 inhibitors in the selectivity of SGLT2 against SGLT1 may affect bone metabolism, since among the SGLT2 inhibitors the selectivity of canagliflozin is lowest. We will investigate whether the SGLT2 inhibitor luseogliflozin, which has higher SGLT2 selectivity, affects bone metabolism by using high-resolution peripheral quantitative computed tomography (HR-pQCT) which provides direct in vivo morphometric information about the bone microarchitecture.Methods This is a single-center, randomized, open-label, active-controlled, parallel pilot trial. Eligible participants are elderly (age ≥60 years) individuals with T2DM with HbA1c levels at 7.0%–8.9%. A total of 24 participants will be allocated to either the luseogliflozin group (taking luseogliflozin) or control group (taking metformin) in a 1:1 ratio to compare the groups' changes in bone microarchitecture of radius and tibia which are analyzed by HR-pQCT before and 48 weeks after the administration of each medication. The laboratory data associated with glycemic control and bone metabolism will be collected every 12 weeks during the study. Recruitment began in June 2019.Discussion The reason we use metformin as an active control is to avoid yielding differences in glycemic control between the luseogliflozin and control groups. Besides, metformin is considered to have neutral effect on bone. This trial will reveal the effect of luseogliflozin on bone metabolism in elderly patients with T2DM.
Keywords
type 2 diabetes, luseogliflozin, SGLT2 inhibitor, HR-pQCT, fracture, bone
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Editorial decision: Accept
On 24 Mar, 2020
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On 20 Mar, 2020
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On 19 Mar, 2020
Version 1
Posted 06 Sep, 2019
No comments provided
Review #2 received
Received 21 Feb, 2020
Editorial decision: Minor revision
On 21 Feb, 2020
Reviewer #2 agreed
On 20 Feb, 2020
Review #1 received
Received 13 Jan, 2020
Reviewers invited
Invitations sent on 11 Oct, 2019
Reviewer #1 agreed
On 11 Oct, 2019
Editor assigned
On 08 Oct, 2019
Submission checks complete
On 03 Sep, 2019
First submitted
On 30 Aug, 2019
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Subject Areas
Integrative & Complementary Medicine
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A new preprint design is coming!
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See the published version of this preprint at Trials.
This is a preprint, a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Study protocol
Ichiro Horie
Corresponding Author
ORCiD: https://orcid.org/0000-0003-3430-5796
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
View the published article at Trials.
No community comments so far
Editorial decision: Accept
On 24 Mar, 2020
Editor assigned
On 20 Mar, 2020
Submission checks complete
On 19 Mar, 2020
Version 1
Posted 06 Sep, 2019
No comments provided
Review #2 received
Received 21 Feb, 2020
Editorial decision: Minor revision
On 21 Feb, 2020
Reviewer #2 agreed
On 20 Feb, 2020
Review #1 received
Received 13 Jan, 2020
Reviewers invited
Invitations sent on 11 Oct, 2019
Reviewer #1 agreed
On 11 Oct, 2019
Editor assigned
On 08 Oct, 2019
Submission checks complete
On 03 Sep, 2019
First submitted
On 30 Aug, 2019
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
Integrative & Complementary Medicine
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published article at Trials.
Background Elderly patients with type 2 diabetes mellitus (T2DM) have an increased risk of bone fracture independent of their bone mineral density (BMD), which is explained mainly by the deteriorated bone quality in T2DM compared to non-diabetic adults. Sodium-glucose co-transporter (SGLT) 2 inhibitors have been studied in several trials in T2DM, and the Canagliflozin Cardiovascular Assessment Study showed an increased fracture risk related to treatment with the SGLT2 inhibitor canagliflozin, although no evidence of increased fracture risk with treatment with other SGLT2 inhibitors has been reported. The mechanism of the difference in the fracture risk between the SGLT2 inhibitors is unknown, but the differences among the SGLT2 inhibitors in the selectivity of SGLT2 against SGLT1 may affect bone metabolism, since among the SGLT2 inhibitors the selectivity of canagliflozin is lowest. We will investigate whether the SGLT2 inhibitor luseogliflozin, which has higher SGLT2 selectivity, affects bone metabolism by using high-resolution peripheral quantitative computed tomography (HR-pQCT) which provides direct in vivo morphometric information about the bone microarchitecture.Methods This is a single-center, randomized, open-label, active-controlled, parallel pilot trial. Eligible participants are elderly (age ≥60 years) individuals with T2DM with HbA1c levels at 7.0%–8.9%. A total of 24 participants will be allocated to either the luseogliflozin group (taking luseogliflozin) or control group (taking metformin) in a 1:1 ratio to compare the groups' changes in bone microarchitecture of radius and tibia which are analyzed by HR-pQCT before and 48 weeks after the administration of each medication. The laboratory data associated with glycemic control and bone metabolism will be collected every 12 weeks during the study. Recruitment began in June 2019.Discussion The reason we use metformin as an active control is to avoid yielding differences in glycemic control between the luseogliflozin and control groups. Besides, metformin is considered to have neutral effect on bone. This trial will reveal the effect of luseogliflozin on bone metabolism in elderly patients with T2DM.
Figure 1
This is a list of supplementary files associated with this preprint. Click to download.
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