Advanced Glycation Endproducts and Bone Material Strength in T2D Treated With Pyridoxamine
| Status: | Recruiting |
|---|---|
| Conditions: | Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 65 - Any |
| Updated: | 12/23/2018 |
| Start Date: | March 1, 2018 |
| End Date: | December 31, 2020 |
| Contact: | Monica Siu,, B.A |
| Email: | mps2205@cumc.columbia.edu |
| Phone: | 212-304-5536 |
Advanced Glycation Endproducts and Bone Material Strength in Type 2 Diabetes Treated With Pyridoxamine
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.
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.
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.
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.
Inclusion Criteria:
- Postmenopausal women ≥65 years
- Diagnosis of T2D for ≥ 10 years, HbA1c ≥6.5%.
Exclusion Criteria:
- HRT use (to avoid the influence of estrogen)
- Current use of pyridoxamine (although not multivitamin or vitamin B6 users because
pyridoxamine is not at pharmacologic levels in these supplements)
- Allergy to pyridoxamine or vitamin B6
- Fractures (excluding skull, facial bones, metacarpals, fingers, toes, and fractures
associated with severe trauma) within 12 months
- A history of pathological fractures (eg, due to Paget's disease, myeloma, metastatic
malignancy)
- Type 1 diabetes
- Disorders associated with altered skeletal structure or function (chronic renal
disease stage IV or V, chronic liver disease, malignancy, hypoparathyroidism or
hyperparathyroidism, acromegaly, Cushing's syndrome, hypopituitarism, chronic
obstructive pulmonary disease, alcohol intake > 3U/day)
- Treatment for blood clots or coagulopathy with warfarin
- Treatment with any of the following drugs in part year: corticosteroids ≥ mg/day (3>
mos. at any time or >10 days), anticonvulsant therapy, pharmacological doses of
thyroid hormone (TSH
fluoride, teriparatide, thiazolidinediones (TZDs), SGLT2 inhibitors, calcium
supplementation > 1200 mg/d (within 3 mos).
We found this trial at
1
site
New York, New York 10032
Principal Investigator: Mishaela Rubin, M.D.
Phone: 212-304-5536
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