Status:
RECRUITING
Gut Hormone LEAP2 in Metabolism and Eating Behaviour: Fixed Meal Testing
Lead Sponsor:
Imperial College London
Conditions:
Eating Behavior
Obesity
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
The goal of this interventional study is to measure the blood levels of the gut hormones LEAP2 and acyl ghrelin (AG), appetite and food intake after consuming liquid meals of different caloric sizes, ...
Eligibility Criteria
Inclusion
- Male or female between the ages of 18 and 60 years;
- Without obesity with body mass index (BMI) 18.0-29.9 kg/m2 or with obesity with BMI 30.0-50.0 kg/m2;
- Healthy as determined by medical history and vital signs;
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form;
- Participant is able to read, comprehend and record information written in English.
Exclusion
- History of, or current abuse or dependence on alcohol or drugs;
- Current smoker or less than 2 years since quitting (cigarette, cigars, e-cigarettes) or use of nicotine replacement therapy;
- Significant current or past medical or psychiatric history that, in the opinion of the investigators, contraindicates their participation;
- History of type 1 or type 2 diabetes mellitus;
- History of ischaemic heart disease, heart failure, cardiac arrhythmia, peripheral vascular, cerebrovascular disease or uncontrolled hypertension;
- Current diagnosis of anaemia or iron deficiency;
- Body weight instability (change in body weight of more than 5% over the preceding 3 months);
- Use of current regular prescription or over-the-counter medications that in the opinion of the Investigators may affect participant safety or outcome measures;
- Clinically significant abnormalities in screening blood tests abnormalities which in the opinion of the study physician, is clinically significant e.g. diabetes mellitus, hypothyroidism, renal impairment, abnormal liver function tests \[bilirubin, alanine transaminase (ALT), aspartate transaminase (AST), gamma-glutamyl transferase (GGT)\] \>3x upper limit of normal, other than due to fatty liver disease; Current pregnancy or breast-feeding in female volunteers (the Investigators will recommend using contraception for the duration of the visits to avoid participant drop-out);
- Pulse rate \<40 or \>100 beats per minute OR systolic blood pressure \>160 and \<100 OR diastolic blood pressure \>95 and \<50 in the semi-supine position;
- Volunteer has participated in a clinical trial and has received an investigational product within the following time period prior to the first experimental visit in the current study: 90 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer);
- Exposure to more than 3 new investigational medicinal products within 12 months prior to the scan;
- Vegan, gluten or lactose-intolerant (as test meals in the paradigms may include animal products, dairy and wheat products);
- Volunteers who have donated, or intend to donate, blood within three months before the screening visit or following study visit completion;
- Known history of SARS-CoV-2 infection (Covid-19) in the last 4 weeks;
- Ongoing symptoms suggestive of complications from previous SARS-CoV-2 infection ('long Covid-19') such as loss or change in sense of smell or taste, shortness of breath, palpitations, lethargy;
- SCOFF questionnaire score \>1/5 indicating eating disorders (Luck et al. 2002);
- DSM-V criteria for alcohol use disorder (AUD) \>2/11 indicating mild AUD (American-Psychiatric-Association 2013);
- Participants who have had previous obesity surgery or are on medications for obesity;
- Dutch Eating Behaviour Questionnaire (DEBQ) restraint score \>3/5 indicating highly restrained eating behaviour.
Key Trial Info
Start Date :
August 29 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06013592
Start Date
August 29 2023
End Date
August 1 2025
Last Update
June 26 2024
Active Locations (1)
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1
PsychoNeuroEndocrinology Research Group, Division of Psychiatry, Dept. of Brain Sciences, Imperial College London
London, United Kingdom, W12 0NN