The effect of pyridoxamine supplementation on vascular function and insulin sensitivity; a double-blind randomized placebo controlled trial in abdominally obese subjects.

Recruiting

• Conditions: Insulin resistance; obesity; 10018424; 10003216

• Registration Number: NL-OMON50192
• Lead Sponsor: niversiteit Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 172

Inclusion Criteria

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

Exclusion Criteria

- Diabetes mellitus (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 will be allowed. Smokers will be excluded only if they smoke >10
cigarettes per day.
- High alcohol usage (>4 U/day) or drug abuse
- Use of medication known to influence glucose metabolism or vascular function
(e.g. glucocorticosteroids, NSAID's)
- Exclusion of higher grade hypertension (> 179 mmHg SBP and/or > 109 mmHg DBP)
in order not to expose subjects to unnecessary risks. Medication is allowed.
- 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified