LEAP2 on Postprandial Glucose Metabolism and Food Intake n Obese Males
LEAP2-OBCT
1 other identifier
interventional
20
1 country
1
Brief Summary
The study aims to delineate the effects of the naturally occurring peptide liver-enriched antimicrobial peptide 2 (LEAP-2) on postprandial glucose metabolism and food intake in obese volunteers. The overall objective is to investigate the physiological importance of LEAP-2 in obese subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable obesity
Started Aug 2022
Shorter than P25 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 24, 2022
CompletedFirst Submitted
Initial submission to the registry
October 19, 2022
CompletedFirst Posted
Study publicly available on registry
November 2, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2023
CompletedNovember 2, 2022
October 1, 2022
8 months
October 19, 2022
October 31, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
Food intake, kilojoules
Difference in food intake during an ad libitum meal. Food intake is examined as kilojoules of food eaten during the ad libitum meal.
290 to 320 minutes
Food intake, kilojoules per kilogram body weight
Difference in food intake during an ad libitum meal. Food intake is examined as kilojoules per kilogram body weight of food eaten during the ad libitum meal.
290 to 320 minutes
Secondary Outcomes (11)
VAS, appetite
-35 to 320 minutes
VAS, satiety
-35 to 320 minutes
VAS, hunger
-35 to 320 minutes
VAS, thirst
-35 to 320 minutes
Alterations in gastric emptying
-35 to 320 minutes
- +6 more secondary outcomes
Study Arms (2)
Placebo
PLACEBO COMPARATORIV infusion of saline, approximately 5.5 hours
Liver-enriched antimicrobial peptide 2
EXPERIMENTALIV infusion of LEAP2, approximately 5.5 hours
Interventions
Intravenous infusion, mixed meal test, ad libitum meal test
Eligibility Criteria
You may qualify if:
- Caucasian men
- Age between 18 and 25 years
- Body mass index between 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 history of hepatobiliary and/or gastrointestinal disorder(s)
- Nephropathy (serum creatinine above normal range and/or albuminuria)
- Allergy or intolerance to ingredients included in the standardised meals
- First-degree relatives with diabetes and/or glycated haemoglobin (HbA1c) \>48 mmol/mol
- Regular tobacco smoking or use of other nicotine-containing products
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Center for Clinical Metabolic Research, Gentofte Hospital
Hellerup, Capital Region, 2900, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, MD, PhD
Study Record Dates
First Submitted
October 19, 2022
First Posted
November 2, 2022
Study Start
August 24, 2022
Primary Completion
May 1, 2023
Study Completion
May 1, 2023
Last Updated
November 2, 2022
Record last verified: 2022-10