The hormone leptin is mainly produced by fat cells in our body. In the human body, the hormone leptin plays a key role in the body's adaptation to a state of hunger. If a person eats too little over a longer period of time, this leads to weight loss and a reduction in fat mass. This also lowers the leptin level in the blood. If the level falls below a certain threshold, numerous functions in the brain and throughout the body are affected, the aim of which is to adjust the organism to a state of hunger. In order to survive, the body then saves energy wherever possible. These include, for example, the cessation of menstruation in women, a drop in body temperature and a reduction in pulse and blood pressure. There is clear evidence from animal experiments that mental functions also change as a result of the drop in leptin levels. For example, physical activity may increase significantly during a state of hunger or depression may occur. Positive effects have already been observed in some patients with anorexia nervosa who have been treated with metreleptin. Therefore, in this study we would like to investigate the effect of metreleptin in a larger number of patients with anorexia nervosa. In order to control for potential influencing factors, half of the participants will receive metreleptin and the other half will receive an inactive substance (placebo).
Aim of the study
The main objective of the study is to investigate the effects of metreleptin - compared to placebo - on depression and body weight in patients with anorexia nervosa. Furthermore, we would like to test the direct effect of metreleptin on the symptoms of anorexia nervosa (e.g., constant thoughts about food, fear of gaining weight, urge to exercise). We also want to investigate how metreleptin affects the brain.
Who can take part?
Criteria for participation in the study (data source: BASEC):
- Diagnosis of anorexia
- BMI > 13 kg/m2; BMI 35 kg
- Hospitalization at the Center for Eating Disorders, Clinic for Consultative Psychiatry and Psychosomatics, University Hospital Zurich
- Age between 18 - 40 years
- Stable physical situation
Exclusion criteria (data source: BASEC):
- Current substance dependence
- Severe mental and/or physical illness: e.g. schizophrenia, inflammatory bowel disease, diabetes, autoimmune diseases, tumors
- Acute suicidal tendencies, current severe self-harming behavior
Procedure
Participants are patients between the ages of 18 and 40 who suffer from anorexia and are receiving inpatient treatment. To study the efficacy of metreleptin, you will be randomly assigned to either the metreleptin group (active drug) or the placebo group (no drug) after a two-week preparation period, and neither you nor the study personnel will be aware of your group assignment throughout the course of the study. This approach is essential to prove the treatment with metreleptin as a possible new treatment approach. In the subsequent treatment phase, you will be injected subcutaneously (i.e. with a very small syringe under the skin) with metreleptin or placebo once a day for 14 days. To be on the safe side, your physical and mental condition will be monitored regularly. Your condition will be checked again after 5 weeks. Before, during and after the treatment, you will fill out questionnaires about your state of health, and blood tests, an ECG and three brain scans will be carried out. You can find more detailed information in the study information documents or by talking to us.
Compensation
200 CHF
Original study name
METRELEPTIN IN ANOREXIA NERVOSA, RANDOMIZED CONTROLLED TRIAL; EFFECTS ON DEPRESSIVE SYMPTOMS AND CONCOMITANT CHANGES IN BRAIN CONNECTIVITY
BASEC number
2022-01328
Sponsors
USZ Foundation - The Foundation of the University Hospital Zurich