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

NCT06254365 | Active Not Recruiting

• 2 other identifiers: H-23042551NNF20OC0084114
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Change in in hepatic MRglu (metabolic rate of glucose)

  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

  During PET-scan (From time 75 minutes to 145 minutes)

Secondary Outcomes (9)

• Standardized uptake values (SUVs)

  During PET-scan (From time 75 minutes to 145 minutes)

• Change MRglu (metabolic rate of glucose) in organs of interest

  During PET-scan (From time 75 minutes to 145 minutes)

• Hepatic intracellular phosphorylation rate

  During PET-scan (From time 75 minutes to 145 minutes)

• Hepatic glucose influx and efflux rates

  During PET-scan (From time 75 minutes to 145 minutes)

• Plasma glucose

  During PET-scan (From time 75 minutes to 145 minutes)

Study Arms (2)

LEAP2 infusion then placebo infusion

EXPERIMENTAL

Participants are randomized to either first recieve LEAP2 infusion and then LEAP2 infusion or th other way around. This arm describes - first LEAP2 infusion and then placebo infusion

Biological: Exogenous LEAP2 hormone

Placebo infusion then LEAP2 infusion

EXPERIMENTAL

Participants are randomized to either first recieve LEAP2 infusion and then LEAP2 infusion or th other way around. This arm describes - first placebo infusion and then LEAP2 infusion

Biological: Exogenous LEAP2 hormone

Interventions

Exogenous LEAP2 hormone BIOLOGICAL

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

LEAP2 infusion then placebo infusion; Placebo infusion then LEAP2 infusion

Eligibility Criteria

• Age: 18 Years - 60 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Caucasian
• Body mass index 30-50 kg/m2
• Informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Gentofte, Copenhagen: lead

Study Sites (1)

Center for Clinical Metabolic Research, Gentofte Hospital

Hellerup, Capital Region, 2900, Denmark

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Filip K Knop, MD, PhD, Professor

  Center for Clinical Metabolic Research, Gentofte Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Professor

Study Record Dates

• First Submitted: February 2, 2024
• First Posted: February 12, 2024
• Study Start: February 21, 2024
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: June 19, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)