Hypothalamic GLP-1 Response in Healthy Weight and Obesity
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity of Copenhagen
About this trial
The goal of this clinical trial is to learn how the gut hormone glucagon-like peptide-1 (GLP-1) helps the brain sense sugar. It includes adults with healthy weight and adults with obesity.
The main questions this trial aims to answer are:
A. Does GLP-1 cause the brain's response to sugar? B. Do lower GLP-1 levels cause a weaker brain response to sugar in adults with obesity?
Researchers will compare each participant's brain response across four test days. On these days, GLP-1 levels will be blocked, raised, or left unchanged. Sugar will be given either into the stomach or into a vein.
Participants will:
Attend 1 screening visit Visit the clinic for 4 test days Receive sugar and get an MRI scan of their brain on each test day
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age 18-75 years
BMI 18.5-25 kg/m²
Normal glucose tolerance (Fasting glucose < 5.6 mmol/L)
Age and sex-matched with group 1
Disqualifiers
Diabetes mellitus type 1 or type 2, or fasting plasma glucose > 7.0 mmol/L
Treatment with GLP-1 receptor agonists or other GLP-1-based therapies within the past three months
Use of medication affecting appetite, body weight, or glucose metabolism within the past three months
Current eating disorder (anorexia nervosa, bulimia nervosa)
Trial design
Design model
Crossover
Treatments tested in this trial
Gastric glucose
Other interventionGastric glucose administration with intravenous saline infusion.
GLP-1(7-36)NH2
Other interventionGLP-1(7-36)NH2 infusion with gastric glucose administration.
Exendin(9-39)NH2
Other interventionExendin(9-39)NH2 infusion with gastric glucose administration.
Isoglycemic intravenous glucose infusion
Other interventionGlucose infusion with rate adjustment to replicate the individual plasma glucose excursion observed during gastric glucose administration on test day 1.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Healthy weightExperimental treatment 4 interventions
Group B: ObesityExperimental treatment 4 interventions
Trial outcomes
Primary outcomes
1
Hypothalamic response to glucose ingestion during GLP-1 receptor blockade compared with saline
Blood oxygen level-dependent (BOLD) time series are extracted from the hypothalamus and expressed relative to the BOLD signal during fasting. The hypothalamic response to glucose ingestion is defined as the relative difference between the gastric glucose condition and the isoglycemic intravenous glucose condition, pre-specified as the net area under the curve (netAUC). This outcome is reported as the difference between conditions in each group, and compared between groups.
Time frame
During the MRI scan on three test days2
Hypothalamic response to glucose ingestion during GLP-1 infusion compared with saline
Blood oxygen level-dependent (BOLD) time series are extracted from the hypothalamus and expressed relative to the BOLD signal during fasting. The hypothalamic response to glucose ingestion is defined as the relative difference between the gastric glucose condition and the isoglycemic intravenous glucose condition, pre-specified as the net area under the curve (netAUC). This outcome is reported as the difference between conditions in each group, and compared between groups.
Time frame
During the MRI scan on three test daysSecondary outcomes
1
Ad libitum energy intake
Energy intake at an ad libitum meal, recorded as an objective measure of satiety, reported as the difference between conditions within each group.
Time frame
After the MRI scan on four test days2
Subjective appetite sensations
Appetite sensations rated on visual analogue scales (0-100 mm; higher scores indicate a stronger sensation), reported as the difference between conditions within each group.
Time frame
Immediately before and immediately after the MRI scan on four test days3
T2 relaxation time in the mediobasal hypothalamus
T2 relaxation time is measured in the mediobasal hypothalamus using a T2-weighted sequence previously validated for quantification of hypothalamic gliosis. Longer T2 relaxation time indicates greater gliosis.
Time frame
During the MRI scan on one of four test day4
Plasma glucose concentration
Glucose concentration (mmol/L) measured in plasma at fasting baseline and at repeated time points during the MRI scan on each test day. Concentrations are reported for each group and compared between groups.
Time frame
Fasting baseline and during the MRI scan on four test daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Copenhagen
Lead sponsor
Copenhagen University Hospital, Rigshospitalet
Collaborator
Source ClinicalTrials.gov
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