No registrations found.
ID
Source
Brief title
Health condition
Obesity
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
The differences in calcitriol-induced dopaminergic effects between lean and obese participants and the effects of calcitriol on satiety, energy metabolism, and food-related behavior (questionnaires) in association with changes in fMRI responses.
Background summary
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.
Study objective
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.
Study design
Both study interventions will be scheduled approximately one week after each other and will each be followed by two additional safety monitoring blood draws.
Intervention
This study consists of two interventions involving one calcitriol and one placebo (saline) infusion (order determined upon randomization).
Inclusion criteria
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).
Exclusion criteria
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
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7536 |
| Other | METC AMC : METC2018_101 |