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

NCT03778580 | Completed DMC

• 1 other identifier: AAAR5451
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Vitamin B6; Diabetes

Outcome Measures

Primary Outcomes (1)

• Bone formation in serum by P1NP

  change in serum biochemical marker of bone formation, P1NP

  12 months

Secondary Outcomes (1)

• Advanced glycation endproducts

  12 months

Study Arms (2)

pyridoxamine

EXPERIMENTAL

pyridoxamine dihydrochloride (over- the- counter type of vitamin B6) 200 mg po bid for one year

Dietary Supplement: Pyridoxamine Dihydrochloride

identical placebo

PLACEBO COMPARATOR

identical placebo po bid for one year

Drug: placebo

Interventions

Pyridoxamine Dihydrochloride DIETARY_SUPPLEMENT

pyridoxamine dihydrochloride (over- the- counter type of vitamin B6) 200 mg po bid

pyridoxamine

placebo DRUG

placebo

identical placebo

Eligibility Criteria

• Age: 65 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Postmenopausal women ≥65 years
• Diagnosis of T2D for ≥ 5 years, with all HbA1c levels.

You may not qualify if:

• 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 (TSH\<normal), adrenal or anabolic steroids, Aromatase inhibitors, calcitonin, bisphosphonates, 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.

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Medical Center - Harkness Pavillion

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

pyridoxamine dihydrochloride

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Mishaela Rubin,, M.D

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: December 12, 2018
• First Posted: December 19, 2018
• Study Start: March 1, 2018
• Primary Completion: February 28, 2022
• Study Completion: February 28, 2022
• Last Updated: August 3, 2022

Record last verified: 2022-08

Locations

US (1)