Status:
COMPLETED
Restriction of Dietary AGEs to Prevent Diabetes in Overweight Individuals
Lead Sponsor:
Maastricht University Medical Center
Conditions:
Advanced Glycation Endproducts
AGEs
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Current efforts to arrest the epidemic of type 2 diabetes mellitus (T2DM) have had limited success. Thus there is an urgent need for effective approaches to prevent the development of T2DM. It is wide...
Eligibility Criteria
Inclusion
- Abdominal obesity: waist circumference for men ≥ 102 cm, and for women ≥ 88 cm.
- Aged 18 years and older
- Caucasian (because of skin fluorescence and capillary microscopy measurements)
Exclusion
- 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)
- 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)
- Pulmonary or inflammatory disease
- Kidney failure or electrolyte disorders
- Pregnancy or lactation
- No change in use of oral anticonceptiva or IUD (12 weeks prior of during the intervention)
- Known allergic reaction to ultrasound contrast-agent
- Smoking (active or cessation \<1 year prior to screening date).
- High alcohol usage (\>4 U/day) or drug abuse
- Use of dietary supplements or an investigation product within the previous month
- Significant food allergies/intolerance
- Vegetarianism
- Subjects who intend to donate blood during the intervention or subjects who have donated blood less than three months before the start of the intervention.
- Participation in another biomedical trial during the past 30 days.
Key Trial Info
Start Date :
September 7 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 3 2021
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT03866343
Start Date
September 7 2018
End Date
March 3 2021
Last Update
March 8 2021
Active Locations (1)
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1
Maastricht University
Maastricht, Limburg, Netherlands, 6226