Clinical trial

Investigating Glucose Metabolism of LEAP2 With Total-body PET/CT

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT06254365

Active, not recruitingNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 60 Years

SexMale

Healthy volunteersAccepted

ConditionObesity

Full registry 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

Treatments and study arms

Exogenous LEAP2 hormone

Biological

This intervention has never been examined in this type of study before.

Primary outcomes

Change in in hepatic MRglu (metabolic rate of glucose)During PET-scan (From time 75 minutes to 145 minutes)

The primary endpoint is the change in hepatic MRglu (metabolic rate of glucose) assessed with total-body PET/CT technique, which will be compared between the two experimental days with infusion of placebo and LEAP2, respectively

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Center for Clinical Metabolic Research, Gentofte Hospital🇩🇰 Hellerup, Capital Region, Denmark

Open map