Obesity MedDRA version: 20.0 Level: PT Classification code 10029883 Term: Obesity System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Sponsors
UZ Leuven
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subject is female between 18 and 65 years of age. Subject has a BMI between 25 and 30 kg/m² and has a stable body weight for at least 3 consecutive months at the start of the study and keeps a stable weight during the study visits. Women of child-bearing potential agree to apply during the entire duration of the trial a highly effective method of birth control, which is defined as those which result in a low failure rate (i.e., less than 1% per year) when used constantly and correctly such as implants, injectables, combined oral contraceptive method, or some intrauterine devices (IUDs), sexual abstinence, or vasectomized partner. Women of non-childbearing potential may be included if surgically sterile (tubal ligation or hysterectomy) or postmenopausal with at least 2 year without spontaneous menses. Subject understands the study procedures and agrees to participate in the study by giving written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subject is under age of legal consent, male, pregnant or breastfeeding. Subject with a BMI = 25 kg/m² or BMI = 30 kg/m². Subject is on a diet to induce weight loss or any other treatment for obesity. Subject has current symptoms or a history of gastrointestinal or other significant somatic or psychiatric diseases or drug allergies. Subject has diabetes. Subject has a significant heart, lung, liver or kidney disease. Subject has any history of a neurological disorder. Subject has a history of abdominal surgery. Those having undergone a simple appendectomy more than 1 year prior to the screening visit may participate. Subject has retinopathy . Subject suffers from psoriasis. Subject has porphyria. Subject shows abnormal eating behavior or has an eating disorder. History or current use of drugs that can affect glycaemia, gastrointestinal function, motility or sensitivity or gastric acidity. History or current use of centrally acting medication, including antidepressants, antipsychotics and/or benzodiazepines (in the last year before screening visit). Subject consumes excessive amounts of alcohol, defined as >14 units per week for women and >21 units per week for men. Subject is currently (defined as within approximately 1 year of the screening visit) a regular or irregular user (including "recreational use") of any illicit drugs (including marijuana) or has a history of drug (including alcohol) abuse. Further, patient is unwilling to refrain from the use of drugs during this study. High caffeine intake (> 500 ml coffee daily or equivalent). Inability or unwillingness to perform all of the study procedures, or the subject is considered unsuitable in any way by the principal investigator. Recent participation (<30 days) or simultaneous participation in another clinical study. Subjects with lactose intolerance. Subjects with quinine allergy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To detect changes in hedonic food intake after acute administration of hydroxychloroquine sulphate compared to placebo;Secondary Objective: (1) To detect changes in the release of gastrointestinal hormones after acute administration of hydroxychloroquine sulphate compared to placebo (2) To detect changes in appetite-related sensations after acute adminsitration of hydroxychloroquine sulphate compared to placebo (3) To detect changes in blood glucose levels after acute administration of hydroxychloroquine sulphate compared to placebo;Primary end point(s): Hedonic food intake compared between placebo and treatment with hydroxychloroquine sulphate;Timepoint(s) of evaluation of this end point: Hedonic food intake will be assessed using a chocolate milkshake drinking task 60 min after administration. Subjects are instructed to drink ad libitum from a chocolate milkshake until fully satiated | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Gastrointestinal hormone release compared between placebo and treatment with hydroxychloroquine sulphate - Appetite-related sensations compared between placebo and treatment with hydroxychloroquine sulphate - Glucose whole blood levels compared between placebo and treatment with hydroxychloroquine sulphate;Timepoint(s) of evaluation of this end point: Hormone release and whole blood glucose will be measured in blood samples collected at regular timepoints after administration. First sample 10 min prior to administration. Followed by collections every 10 min after administration for a period of one hour. A final blood samples will be collected 30 min after consumption of the chocolate milkshake. Appetite-related sensations (hunger, prospective food consumption, fullness and satiety) will be scored by the subjects on visual analogue scales of 100 mm. Subjects will score their appetite-related sensations every 10 min from the start of the study until the end. | — |
Countries
Belgium
Contacts
Public ContactClinical Trials info TARGID
KU Leuven
Outcome results
None listed