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

• Status: Active, not recruiting
• Trial end date: 2022-02-28
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Columbia University
• Treatments: Pyridoxal; Pyridoxamine; Pyridoxine; Vitamin B 6; Vitamins

Criteria

Inclusion Criteria:

• Postmenopausal women ≥65 years

• Diagnosis of T2D for ≥ 5 years, with all HbA1c levels.

Exclusion Criteria:

• Hormone replacement treatment (HTR) use (to avoid the influence of estrogen).

• 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 liver disease' chronic renal disease stage 4 [eGFR < 30 mL/mim/1.73 m2] or worse, malignancy, hypoparathyroidism or hyperparathyroidism,acromegaly, Cushing's syndrome, hypopituitarism, alcohol intake > 3U/day).

• Treatment with any of the following drugs in part year:current corticosteroid, anticonvulsant therapy(phenytoin, phenobarbital, primidone, carbamazepine), SGLT2 inhibitor if on it for < 1 year), pharmacological doses of thyroid hormone (TSHbisphosphonates, denosumab, estrogen, or selective estrogen receptor modulator, sodium fluoride, teriparatide, thiazolidinediones(TZDs).

• Serum 25(OH)D levels < 20 ng/ml. If 25(OH)D levels are < 20 ng/ml, rescreening will be allowed following a vitamin D loading regimen of 50,000 IU/week for 4 weeks. If serum 25(OH) D levels are ≥ 20 ng/ml after supplementation, the subject will be allowed to enroll.

• Current use of pyridoxamine (although not multivitamin or vitamin B6 users because pyridoxamine is not at pharmacologic levels in these supplements).

• Allergy to pyridoxamine and vitamin B6.