Abdominal Obesity Metabolic SyndromeNCT02954588
Effect of Pyridoxamine Supplementation on Vascular Function and Insulin Sensitivity
A study testing Pyridoxamine in people with Abdominal Obesity Metabolic Syndrome, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Abdominal Obesity Metabolic Syndrome
- What is being tested?
- Pyridoxamine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 1 siteNetherlands
- Study dates
- 14 Oct 2016to 8 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Pyridoxamine Supplementation on Vascular Function and Insulin Sensitivity; a Double-blind Randomized Placebo Controlled Trial in Abdominally Obese Subjects.
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.
- Conditions
- Abdominal Obesity Metabolic Syndrome
- Being tested
- Pyridoxamine, Placebo
- Medical subject headings
- Abdominal obesity metabolic syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PyridoxamineDietary supplement
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Pyridoxamine (1) | Active comparator | Subjects will be asked to consume dietary supplements containing pyridoxamine (dosage 1), three times daily during 8 weeks. Receives: Dietary Supplement: Pyridoxamine |
| Pyridoxamine (2) | Active comparator | Subjects will be asked to consume dietary supplements containing pyridoxamine (dosage 2), three times daily during 8 weeks Receives: Dietary Supplement: Pyridoxamine |
| Placebo | Placebo comparator | Subjects will be asked to consume dietary supplements containing placebo (amylum solani), three times daily during 8 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensitivity
Assessed by hyperinsulinemic-euglycemic clamp
Measured: Difference after 8 weeks of intervention
Microvascular function
Assessed by contrast-enhanced ultrasound (CEUS) in skeletal muscle
Measured: Difference after 8 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2016 (estimated)
- Study start14 Oct 2016
- Primary completion20 Jan 2020
- Study completion8 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Abdominal Obesity Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Top Institute Food and Nutrition, Center for Translational Molecular Medicine
- Responsible party
- Sponsor
- Investigators
- Casper G Schalkwijk, PhD, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02954588
- Sponsor's protocol ID
- NL51023.068.16
- Status last verified
- Sep 2020
- First submitted
- 2 Nov 2016
- Last updated
- 1 Oct 2020
- Results posted
- No
Publications
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.
PubMed 34229268
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pyridoxamine Supplementation on Vascular Function and Insulin Sensitivity; a Double-blind Randomized Placebo Controlled Trial in Abdominally Obese Subjects.
- ClinicalTrials.gov ID
- NCT02954588
- Acronym / sponsor ID
- NL51023.068.16
- Conditions
- Abdominal Obesity Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Top Institute Food and Nutrition, Center for Translational Molecular Medicine
- Study start
- 14 Oct 2016 (actual)
- Primary completion
- 20 Jan 2020 (actual)
- Study completion
- 8 Aug 2020 (actual)
- First posted
- 3 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pyridoxamine (1) | Active comparator | Dietary Supplement: PyridoxamineSubjects will be asked to consume dietary supplements containing pyridoxamine (dosage 1), three times daily during 8 weeks. |
| Pyridoxamine (2) | Active comparator | Dietary Supplement: PyridoxamineSubjects will be asked to consume dietary supplements containing pyridoxamine (dosage 2), three times daily during 8 weeks |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboSubjects will be asked to consume dietary supplements containing placebo (amylum solani), three times daily during 8 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pyridoxamine | Dietary supplement | Pyridoxamine (1), Pyridoxamine (2) |
| Placebo | Dietary supplement | Placebo |
Primary outcome
Insulin sensitivity
Time frame: Difference after 8 weeks of intervention
Assessed by hyperinsulinemic-euglycemic clamp
Microvascular function
Time frame: Difference after 8 weeks of intervention
Assessed by contrast-enhanced ultrasound (CEUS) in skeletal muscle
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2020.
- Derived from this study: PubMed 34229268Van 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Casper G Schalkwijk, PhD principal investigator
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pyridoxamine in people with Abdominal Obesity Metabolic Syndrome, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin sensitivity (time frame: Difference after 8 weeks of intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02954588, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2020.