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

Primary Purpose

Diabetes Mellitus, Type 2

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Pyridoxamine Dihydrochloride

placebo

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Vitamin B6, Diabetes

Eligibility Criteria

65 Years - undefined (Older Adult)FemaleDoes not accept healthy volunteers

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 (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.

Sites / Locations

Columbia University Medical Center - Harkness Pavillion

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

pyridoxamine

identical placebo

Arm Description

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

identical placebo po bid for one year

Outcomes

Primary Outcome Measures

Bone formation in serum by P1NP

change in serum biochemical marker of bone formation, P1NP

Secondary Outcome Measures

Advanced glycation endproducts

Skin assessment of advanced glycation endproducts

Full Information

NCT ID

NCT03778580

First Posted

December 12, 2018

Last Updated

August 1, 2022

Sponsor

Columbia University

1. Study Identification

Unique Protocol Identification Number

NCT03778580

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Completed

Study Start Date

March 1, 2018 (Actual)

Primary Completion Date

February 28, 2022 (Actual)

Study Completion Date

February 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Columbia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 2

Keywords

Vitamin B6, Diabetes

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

55 (Actual)

8. Arms, Groups, and Interventions

Arm Title

pyridoxamine

Arm Type

Experimental

Arm Description

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

Arm Title

identical placebo

Arm Type

Placebo Comparator

Arm Description

identical placebo po bid for one year

Intervention Type

Dietary Supplement

Intervention Name(s)

Pyridoxamine Dihydrochloride

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

placebo

Primary Outcome Measure Information:

Title

Bone formation in serum by P1NP

Description

change in serum biochemical marker of bone formation, P1NP

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Advanced glycation endproducts

Description

Skin assessment of advanced glycation endproducts

Time Frame

12 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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 (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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mishaela Rubin,, M.D

Organizational Affiliation

Columbia University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Columbia University Medical Center - Harkness Pavillion

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

12. IPD Sharing Statement

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

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