Back to results

Effect of Pyridoxamine Supplementation on Vascular Function and Insulin Sensitivity

Primary Purpose

Abdominal Obesity Metabolic Syndrome

Status

Completed

Phase

Not Applicable

Locations

Netherlands

Study Type

Interventional

Intervention

Pyridoxamine

Placebo

About this trial

This is an interventional basic science trial for Abdominal Obesity Metabolic Syndrome

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Abdominal obesity: Waist circumference for men should be above 102 cm and for women above 88 cm.
Caucasian (because of skin fluorescence and capillary microscopy measurements)
Aged 18-75 years

Exclusion Criteria:

Diabetes (i.e. using anti-diabetic medication, fasting glucose >7.0 mmol/L, HbA1c >6.5%).
Active or history of cardiovascular disease (e.g. stroke, coronary artery disease, peripheral vascular disease, congestive heart failure, cardiac shunts, cardiac surgery, pulmonary hypertension, cardiac arrhythmias, family history of cardiac arrhythmias or sudden cardiac death)
Hyperlipidemia (defined as serum total cholesterol > 8 mmol/L or TG > 4 mmol/L)
Smoking (>10 cigarettes per day)
High alcohol usage (>4 U/day) or drug abuse
Use of medication known to influence glucose metabolism, vascular function (e.g. glucocorticosteroids, NSAID's)
Higher grade hypertension (> 179 mmHg SBP and/or > 109 mmHg DBP) in order not to expose subjects to unnecessary risks)
Known allergic reaction to ultrasound contrast-agent
Pulmonary or inflammatory disease
Kidney failure or electrolyte disorders
Use of dietary supplements or an investigational product within the previous month
Unstable body weight (no drastic changes in life style before or during the intervention are allowed, this means no weight gain or loss >3 kg in the last two months)
Pregnancy or lactation
No change in use of oral anticonceptiva or IUD (12 weeks prior of during the intervention)
Unwillingness to give up being a blood donor (or having donated blood) from 8 weeks prior to the start of the study and during the study
Insufficient knowledge of the Dutch language

Sites / Locations

Maastricht University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Pyridoxamine (1)

Pyridoxamine (2)

Placebo

Arm Description

Subjects will be asked to consume dietary supplements containing pyridoxamine (dosage 1), three times daily during 8 weeks.

Subjects will be asked to consume dietary supplements containing pyridoxamine (dosage 2), three times daily during 8 weeks

Subjects will be asked to consume dietary supplements containing placebo (amylum solani), three times daily during 8 weeks

Outcomes

Primary Outcome Measures

Insulin sensitivity

Assessed by hyperinsulinemic-euglycemic clamp

Microvascular function

Assessed by contrast-enhanced ultrasound (CEUS) in skeletal muscle

Secondary Outcome Measures

Full Information

NCT ID

NCT02954588

First Posted

November 2, 2016

Last Updated

September 29, 2020

Sponsor

Maastricht University Medical Center

Collaborators

Top Institute Food and Nutrition, Center for Translational Molecular Medicine

1. Study Identification

Unique Protocol Identification Number

NCT02954588

Brief Title

Effect of Pyridoxamine Supplementation on Vascular Function and Insulin Sensitivity

Official Title

The Effect of Pyridoxamine Supplementation on Vascular Function and Insulin Sensitivity; a Double-blind Randomized Placebo Controlled Trial in Abdominally Obese Subjects.

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Completed

Study Start Date

October 14, 2016 (Actual)

Primary Completion Date

January 20, 2020 (Actual)

Study Completion Date

August 8, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Maastricht University Medical Center

Collaborators

Top Institute Food and Nutrition, Center for Translational Molecular Medicine

4. Oversight

5. Study Description

Brief Summary

A growing body of evidence demonstrates that increased adipose mass, especially visceral adipose tissue, contributes directly towards an increase in systemic inflammation, (micro-)vascular dysfunction and the burden of cardiovascular disease (CVD), insulin resistance and type 2 diabetes. Advanced glycation/lipoxidation endproducts (AGEs/ALEs) are a heterogeneous family of unavoidable by-products, which are formed by reactive metabolic intermediates derived from glucose and lipid oxidation. In addition to the overwhelming amount of data demonstrating the role of AGEs/ALEs in the development of (micro-)vascular dysfunction and disease, accumulation of AGEs/ALEs in the expanding adipose tissue contributes to the dysregulation of adipokines and the development of insulin resistance. The investigators want to examine, in a double-blind randomized placebo controlled parallel study, the physiological effect of a dietary intervention with pyridoxamine in abdominally obese persons. A sub-study is implemented next to the clinical trial. The objective of the sub-study is to measure the metabolization and kinetics of pyridoxamine in plasma and urine with UPLC-MS/MS. The sub-study comprises of 5 additional healthy volunteers, with pyridoxamine as an oral supplement.

6. Conditions and Keywords

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

Abdominal Obesity Metabolic Syndrome

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

112 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Pyridoxamine (1)

Arm Type

Active Comparator

Arm Description

Subjects will be asked to consume dietary supplements containing pyridoxamine (dosage 1), three times daily during 8 weeks.

Arm Title

Pyridoxamine (2)

Arm Type

Active Comparator

Arm Description

Subjects will be asked to consume dietary supplements containing pyridoxamine (dosage 2), three times daily during 8 weeks

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Subjects will be asked to consume dietary supplements containing placebo (amylum solani), three times daily during 8 weeks

Intervention Type

Dietary Supplement

Intervention Name(s)

Pyridoxamine

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Insulin sensitivity

Description

Assessed by hyperinsulinemic-euglycemic clamp

Time Frame

Difference after 8 weeks of intervention

Title

Microvascular function

Description

Assessed by contrast-enhanced ultrasound (CEUS) in skeletal muscle

Time Frame

Difference after 8 weeks of intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Abdominal obesity: Waist circumference for men should be above 102 cm and for women above 88 cm. Caucasian (because of skin fluorescence and capillary microscopy measurements) Aged 18-75 years Exclusion Criteria: Diabetes (i.e. using anti-diabetic medication, fasting glucose >7.0 mmol/L, HbA1c >6.5%). Active or history of cardiovascular disease (e.g. stroke, coronary artery disease, peripheral vascular disease, congestive heart failure, cardiac shunts, cardiac surgery, pulmonary hypertension, cardiac arrhythmias, family history of cardiac arrhythmias or sudden cardiac death) Hyperlipidemia (defined as serum total cholesterol > 8 mmol/L or TG > 4 mmol/L) Smoking (>10 cigarettes per day) High alcohol usage (>4 U/day) or drug abuse Use of medication known to influence glucose metabolism, vascular function (e.g. glucocorticosteroids, NSAID's) Higher grade hypertension (> 179 mmHg SBP and/or > 109 mmHg DBP) in order not to expose subjects to unnecessary risks) Known allergic reaction to ultrasound contrast-agent Pulmonary or inflammatory disease Kidney failure or electrolyte disorders Use of dietary supplements or an investigational product within the previous month Unstable body weight (no drastic changes in life style before or during the intervention are allowed, this means no weight gain or loss >3 kg in the last two months) Pregnancy or lactation No change in use of oral anticonceptiva or IUD (12 weeks prior of during the intervention) Unwillingness to give up being a blood donor (or having donated blood) from 8 weeks prior to the start of the study and during the study Insufficient knowledge of the Dutch language

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Casper G Schalkwijk, PhD

Organizational Affiliation

Maastricht University Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Maastricht University Medical Center

City

Maastricht

ZIP/Postal Code

6200MD

Country

Netherlands

12. IPD Sharing Statement

Citations:

PubMed Identifier

34229268

Citation

Van den Eynde MDG, Scheijen JLJM, Stehouwer CDA, Miyata T, Schalkwijk CG. Quantification of the B6 vitamers in human plasma and urine in a study with pyridoxamine as an oral supplement; pyridoxamine as an alternative for pyridoxine. Clin Nutr. 2021 Jul;40(7):4624-4632. doi: 10.1016/j.clnu.2021.05.028. Epub 2021 Jun 10.

Results Reference

derived

Learn more about this trial

Effect of Pyridoxamine Supplementation on Vascular Function and Insulin Sensitivity

We'll reach out to this number within 24 hrs