Clinical trial

Effects of Antagonizing the Ghrelin Receptor on Total-body Glucose Metabolism in Obesity

Name
H-23042551
Description
The naturally occurring hormone LEAP2 is proposed to have opposite effects to that of the 'hunger hormone' ghrelin. Other that appetite regulation, LEAP2 is involved in glucose metabolism through mechanisms yet not fully understood. With two experimental days; one recieving LEAP2 and one recieving placebo infusion in a randomized order, the study will explore the effect of LEAP2 (vs. placebo) on glucose metabolism through total-body PET/CT-scans and thereby gain a deeper understanding of the ghrelin/LEAP2 system and its interaction with glucose metabolism. Furthermore, the project will generate scanning references in individuals with obesity that are usable in forthcoming research projects.
Trial arms
Trial start
2024-02-05
Estimated PCD
2024-08-01
Trial end
2025-02-01
Status
Recruiting
Treatment
Exogenous LEAP2 hormone
This intervention has never been examined in this type of study before.
Arms:
LEAP2 infusion then placebo infusion, Placebo infusion then LEAP2 infusion
Size
9
Primary endpoint
Change in in hepatic MRglu (metabolic rate of glucose)
During PET-scan (From time 75 minutes to 145 minutes)
Eligibility criteria
Inclusion Criteria: * Caucasian * Age between 18 and 60 years at the time of inclusion * Body mass index 30-50 kg/m2 * Informed consent Exclusion Criteria: * Anaemia (haemoglobin below normal range) * Alanine aminotransferase (ALAT) and/or aspartate aminotransferase (ASAT) ≥2 times normal values) or present hepatobiliary and/or gastrointestinal disorder(s) * Nephropathy (serum creatinine above normal range and/or albuminuria) * Glycated haemoglobin (HbA1c) ≥48 mmol/mol and/or type 2 diabetes requiring medical treatment * Regular tobacco smoking or use of other nicotine-containing products * Claustrophobia * Any ongoing medication that the investigator evaluates would interfere with trial participation. * Any physical or psychological condition that the investigator evaluates would interfere with trial participation including any acute or chronic illnesses
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 9, 'type': 'ESTIMATED'}}
Updated at
2024-02-14

1 organization

1 product

1 indication

Indication
Obesity