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

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ClinicalTrials.gov Identifier: NCT03778580
Recruitment Status : Recruiting
First Posted : December 19, 2018
Last Update Posted : May 24, 2019
Sponsor:
Information provided by (Responsible Party):
Mishaela Rubin, Columbia University

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Dietary Supplement: Pyridoxamine Dihydrochloride Drug: placebo Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Advanced Glycation Endproducts and Bone Material Strength in Type 2 Diabetes Treated With Pyridoxamine
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: pyridoxamine
pyridoxamine dihydrochloride (over- the- counter type of vitamin B6) 200 mg po bid for one year
Dietary Supplement: Pyridoxamine Dihydrochloride
pyridoxamine dihydrochloride (over- the- counter type of vitamin B6) 200 mg po bid

Placebo Comparator: identical placebo
identical placebo po bid for one year
Drug: placebo
placebo




Primary Outcome Measures :
  1. Bone formation in serum by P1NP [ Time Frame: 12 months ]
    change in serum biochemical marker of bone formation, P1NP

  2. Bone material strength [ Time Frame: 12 months ]
    bone material strength index by impact microindentation


Secondary Outcome Measures :
  1. Advanced glycation endproducts [ Time Frame: 12 months ]
    Skin assessment of advanced glycation endproducts



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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 for blood clots or coagulopathy. Only Coumadin will be excluded. Other blood thinners will not be exclusionary because there has been no excessive bleeding with the use of these agents with microindentation according to Dr. Adolfo Diez-Perez, a leader in the technique of microindentation.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03778580


Contacts
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Contact: Monica Siu,, B.A 212-304-5536 mps2205@cumc.columbia.edu
Contact: Rukshana Majeed,, B.A 212-305-9489 rm3324@columbia.edu

Locations
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United States, New York
Columbia University Medical Center - Harkness Pavillion Recruiting
New York, New York, United States, 10032
Contact: Monica Siu Clinical Research Coordinator    212-304-5536    mps2205@cumc.columbia.edu   
Contact: Rukshana Majeed Clinical Research Coordinator    212-305-9489    rm3324@columbia.edu   
Principal Investigator: Mishaela Rubin, M.D.         
Sponsors and Collaborators
Columbia University
Investigators
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Principal Investigator: Mishaela Rubin,, M.D Columbia University
  Study Documents (Full-Text)

Documents provided by Mishaela Rubin, Columbia University:
Study Protocol  [PDF] October 10, 2018


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Responsible Party: Mishaela Rubin, Associate Professor of Medicine, Columbia University
ClinicalTrials.gov Identifier: NCT03778580    
Other Study ID Numbers: AAAR5451
First Posted: December 19, 2018    Key Record Dates
Last Update Posted: May 24, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mishaela Rubin, Columbia University:
Vitamin B6
Diabetes
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vitamins
Vitamin B 6
Pyridoxal
Pyridoxine
Pyridoxamine
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Vitamin B Complex