Vitamin D3 in Obesity: Identification of Central Nervous System Targets Using High-Technology Functional MRI

Investigator initiated trial0 个研究点目标入组 30 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

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•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).

•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

发起方

Investigator initiated trial