Advanced Glycation Endproducts and Bone Material Strength in T2D Treated With Pyridoxamine

Diabetes Mellitus, Type 2 Clinical Trial

Official title: Advanced Glycation Endproducts and Bone Material Strength in Type 2 Diabetes Treated With Pyridoxamine

Status Completed

Clinical Trial Summary

The purpose of this study is to determine if a specific form of Vitamin B known as Pyridoxamine helps improve bone strength over one year in women (>65 yrs old) with Type 2 Diabetes. The investigators know that people with type 2 diabetes have the lower bone material strength and the investigators suspect this is due to high levels of circulating sugars that build up over time (known as Advanced Glycation Endproducts). The investigators will study whether using a specific form of vitamin B, known as pyridoxamine helps improve bone strength and reduce levels of circulating sugars over a one year time period.

Clinical Trial Description

Type 2 Diabetes Mellitus (T2DM) has become one of the most important diseases of our time. Recent research shows that diabetes has negative effects on bones and that people with diabetes might more likely to break a bone. The investigators don't know the reasons for this, but the investigators suspect that normal bone replacement is slowed down in diabetes and this could slow down the growth of new bone. It is possible that the normal material becomes weaker because sugar-related components ("Advanced Glycation Endproducts") are making the bone more brittle. The investigators have shown in past research that people who have type 2 diabetes are more likely to have both weaker bone with lower "bone material strength" and also higher level of sugar-related components("Advanced Glycation Endproducts"). This study will focus on attempting to lower the sugar-related components("Advanced Glycation Endproducts") by treating a group of patients with type 2 diabetes with an over- the- counter B vitamin, known as vitamin B6 or pyridoxamine for one year. The investigators will compare post-menopausal women both before and after pyridoxamine use and study them in terms of different bone features based on blood tests, bone imaging, a bone indentation test and a measurement of sugar-related components in the skin. This study will help to clarify if using pyridoxamine helps improve bone strength in women with diabetes. ;

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

• NCT number: NCT03778580
• Study type: Interventional
• Source: Columbia University
• Status: Completed
• Phase: N/A
• Start date: March 1, 2018
• Completion date: February 28, 2022