After calcitriol treatment, i. resting state striatal neuronal activity, i.e. BOLD signal, is increased and ii. visual food stimuli-induced neuronal activity of brain areas involved in food intake is reduced.
ID
Bron
Verkorte titel
Aandoening
Obesity
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The effects of calcitriol on neuronal activity in brain areas involved in food intake using functional magnetic resonance imaging (fMRI) in lean and obese subjects.
Achtergrond van het onderzoek
Obesity and obesity-related complications are associated with reduced quality of life and increased social and healthcare-related costs. Altered brain dopamine signaling has been implicated in the development and progression of obesity. Recent evidence from animal studies showed that calcitriol treatment increases dopamine release and reduces food intake and body weight. Whether this is similar in humans has not been experimentally explored. Therefore, we will perform a study to investigate the effects of calcitriol on neuronal activity in brain areas involved in food intake using functional magnetic resonance imaging (fMRI) in lean and obese subjects.
Doel van het onderzoek
After calcitriol treatment, i. resting state striatal neuronal activity, i.e. BOLD signal, is increased and ii. visual food stimuli-induced neuronal activity of brain areas involved in food intake is reduced.
Onderzoeksopzet
Both study interventions will be scheduled approximately one week after each other and will each be followed by two additional safety monitoring blood draws.
Onderzoeksproduct en/of interventie
This study consists of two interventions involving one calcitriol and one placebo (saline) infusion (order determined upon randomization).
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
Age between 18 – 35 years;
Capability to provide informed consent;
Stable weight (<5% change) for 3 months prior to study assessment.
Additionally, for the obese subset:
BMI between 30 – 40 kg/m2;
Metabolically unhealthy, defined as fasting plasma insulin levels >74 pmol/l at screening (89).
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
A potential subject who meets any of the following criteria will be excluded from participation in this study:
Any medical disorder (with the exception of metabolic syndrome and other obesity-related disorders in the obese subset);
Childhood-onset obesity;
Contraindication to MRI scanning (e.g. claustrophobia, pacemaker, metal IUD);
Participants who skip their breakfast or work in shifts;
Serum 25-hydroxyvitamin D (25(OH)D) concentrations below 50 nmol L−1;
Significant sensory or motor impairment;
Subjects taking any medication except for medication for obesity-related metabolic disorders (excluding diabetes treatment)
Subjects who cannot adhere to the experimental protocol for any reason;
The use of weight loss agents or use within 3 months prior to study;
Weight loss surgery or gastrectomy.
Hypercalciemia at screening
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL7536 |
| Ander register | METC AMC : METC2018_101 |