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Study on dietary fat retention in liver using MRI

Tracking of dietary fatty acids in liver by 1H-[13C]- magnetic resonance spectroscopy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON28348
Enrollment
20
Registered
2015-10-30
Start date
2012-08-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fatty liver/NAFLD, type 2 diabetes (T2DM).

Interventions

High fat meal with 13C labeled fatty acids

Sponsors

Maastricht University Medical Center
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion criteria: Lean subjects (study 1): - Age 18-65 years - Normal BMI 18-25 kg/m2 - Stable dietary habits - Generally healthy, no medication use Obese subjects (study 2): - Age 18-65 years, - Obese, BMI 30-35 kg/m2 - Stable dietary habits (no weight-reducing diet last year) - Generally healthy, no medication use

Exclusion criteria

Exclusion criteria: Persons that have any of the following will be excluded from the study: - Any medical condition requiring treatment and/or medication use - Alcohol consumption of more than 20 g per day (± 2 units) or other drug abuse - Unstable body weight (weight gain or loss > 3 kg in the past three months) - Contraindications for MRI scan: • Aneurysm clips • Implanted neural stimulator • Implanted cardiac pacemaker of defibrillator • Cochlear implant • Iron- containing corpora aliena in the eye or brain • Artificial (heart) valves which is contraindicated for MRS • Claustrophobia - Subjects, who do not want to be informed about unexpected medical findings, or do not wish that their treating physician is informed, cannot participate in the study. Possible unexpected findings could include: dark or highlighted spots in the liver or contrast differences between different muscle groups. In case one of those unexpected findings are recognised by the performing researcher, a radiologist will be contacted first for advice. On his/her advice further investigations will be performed and/or the physician will be contacted.

Design outcomes

Primary

MeasureTime frame
The main study parameters per study-group are: Studie 1 (lean subjects) -Determination of the lowest dose that allows for sufficient signal to noise ratio and to determine time of maximal 13C accumulation in liver. Time point of maximal increase. Studie 2 (obese subjects) -Minimal dose for significant postprandial increase of enrichment in liver. -Time point of maximal increase. -Difference in dose compared to lean subjects.

Secondary

MeasureTime frame
• Total- and 13C-enriched blood plasma levels of FFA, triglycerides, glucose.

Contacts

Public ContactLucas Lindeboom
lucas.lindeboom@maastrichtuniversity.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)