Digestion disorder
Conditions
Interventions
n.a.
Sponsors
Centre for Human Drug Research
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Male and female subjects, 18 to 50 years of age, inclusive. Obese metabolic unhealthy volunteers with a BMI =30 kg/m2, waist circumference / height = 0.5 and 2 or more criteria for MetS, age and sex matched with healthy volunteer cohort, orHealthy body mass index (BMI) between 18 and 25 kg/m2 and a minimum weight of 50 kg.Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, haematology, blood chemistry, blood serology and urinalysis. In the case of uncertain or questionable results, tests performed during screening may be repeated before randomization to confirm eligibility or judged to be clinically irrelevant for healthy/obese subjects.Subjects of childbearing potential must use effective contraception (see paragraph 4.4.2) for the full duration of the study. Women of childbearing potential are defined as all women physiologically capable of becoming pregnant, unless they meet one of the following conditions:Post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 weeks after surgical bilateral oophorectomy with or without hysterectomy;Post-hysterectomyAble and willing to give written informed consent and to comply with the study restrictions including 48-hour fasting.
Exclusion criteria
Exclusion criteria: Clinically significant abnormalities, as judged by the investigator, in laboratory test results (including hepatic and renal panels, complete blood count, chemistry panel and urinalysis). In the case of uncertain or questionable results, tests performed during screening may be repeated before inclusion or randomization to confirm eligibility or judged to be clinically irrelevant for healthy/obese subjects.Participation in an investigational drug or device study within 3 months prior to dosing or within five half-lives of the investigational drug.Loss or donation of blood over 500 mL within three months prior to screening or donation of plasma within 14 days of screening.Any history or current presence of a (medical) condition that would, in the opinion of the investigator, potentially compromise the safety or compliance of the patient or may preclude the patient’s successful completion of the clinical trial.Smoking of nicotine containing products > 3/ week.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood-based: Transcriptomics: RNAs Fat biopsy Transcriptomics: RNAs | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood based: Metabolism in circulating cells using phosphoflow. Metabolism in tissue-resident immune cells (flowcytometry leukocytes from fat biopsy) Proteomics: Olink reveal panel Metabolomics Gut metabolite panel Lipid panel Fat biopsy: Proteomics: Olink reveal panel Metabolomics Gut metabolite panel Lipid panel Feces: Microbiome composition optional Metabolomics optional | — |
Countries
Netherlands
Contacts
Public ContactN Klarenbeek
Centre for Human Drug Research
Outcome results
None listed