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Effect of Pyridoxamine Supplementation on Vascular Function and Insulin Sensitivity

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ClinicalTrials.gov Identifier: NCT02954588
Recruitment Status : Recruiting
First Posted : November 3, 2016
Last Update Posted : May 1, 2018
Sponsor:
Collaborators:
Top Institute Food and Nutrition
Center for Translational Molecular Medicine
Information provided by (Responsible Party):
Maastricht University Medical Center

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.


Condition or disease Intervention/treatment Phase
Abdominal Obesity Metabolic Syndrome Dietary Supplement: Pyridoxamine Dietary Supplement: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Effect of Pyridoxamine Supplementation on Vascular Function and Insulin Sensitivity; a Double-blind Randomized Placebo Controlled Trial in Abdominally Obese Subjects.
Actual Study Start Date : October 14, 2016
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Pyridoxamine (1)
Subjects will be asked to consume dietary supplements containing pyridoxamine (dosage 1), three times daily during 8 weeks.
Dietary Supplement: Pyridoxamine
Active Comparator: Pyridoxamine (2)
Subjects will be asked to consume dietary supplements containing pyridoxamine (dosage 2), three times daily during 8 weeks
Dietary Supplement: Pyridoxamine
Placebo Comparator: Placebo
Subjects will be asked to consume dietary supplements containing placebo (amylum solani), three times daily during 8 weeks
Dietary Supplement: Placebo



Primary Outcome Measures :
  1. Insulin sensitivity [ Time Frame: Difference after 8 weeks of intervention ]
    Assessed by hyperinsulinemic-euglycemic clamp

  2. Microvascular function [ Time Frame: Difference after 8 weeks of intervention ]
    Assessed by contrast-enhanced ultrasound (CEUS) in skeletal muscle



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Abdominal obesity: Waist circumference for men should be between 102 cm and 120 cm, for women between 88 cm and 106 cm.
  • Caucasian (because of skin fluorescence and capillary microscopy measurements)
  • Aged 18-65 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 (active or cessation <1 year prior to screening date)
  • High alcohol usage (>4 U/day) or drug abuse
  • Lipid lowering medication (e.g. statins)
  • Use of medication known to influence glucose metabolism, vascular function and/or lipid metabolism (e.g. statins, glucocorticosteroids, NSAID's)
  • Inability to stop antihypertensive medication for 13 weeks. Exclusion of 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

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): NCT02954588


Contacts
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Contact: Mathias Van den Eynde +31 (0) 433884250 m.vandeneynde@maastrichtuniversity.nl

Locations
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Netherlands
Maastricht University Medical Center Recruiting
Maastricht, Netherlands, 6200MD
Contact: Mathias Van den Eynde    +31 (0) 433884250    m.vandeneynde@maastrichtuniversity.nl   
Sponsors and Collaborators
Maastricht University Medical Center
Top Institute Food and Nutrition
Center for Translational Molecular Medicine
Investigators
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Principal Investigator: Casper G Schalkwijk, PhD Maastricht University Medical Center

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Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT02954588     History of Changes
Other Study ID Numbers: NL51023.068.16
First Posted: November 3, 2016    Key Record Dates
Last Update Posted: May 1, 2018
Last Verified: April 2018

Additional relevant MeSH terms:
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Metabolic Syndrome
Insulin Resistance
Obesity, Abdominal
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Obesity
Overnutrition
Nutrition Disorders
Insulin
Pyridoxamine
Hypoglycemic Agents
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances