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Clinical Trials in Denmark / NCT07854886
Starting soon Not applicable

Hypothalamic GLP-1 Response in Healthy Weight and Obesity

NCT07854886 · tracked via the Priya Life Science Denmark tracker
Sponsor
University of Copenhagen
Phase
Not applicable
Started
2026-10-01
Last updated
2026-10-02

Condition(s) studied

ObesityNormal WeightGlucose Intolerance

Investigational drug(s) / intervention(s)

Gastric glucoseGLP-1(7-36)NH2Exendin(9-39)NH2Isoglycemic intravenous glucose infusion

Gastric glucose: Gastric glucose administration with intravenous saline infusion.

GLP-1(7-36)NH2: GLP-1(7-36)NH2 infusion with gastric glucose administration.

Exendin(9-39)NH2: Exendin(9-39)NH2 infusion with gastric glucose administration.

Isoglycemic intravenous glucose infusion: Glucose infusion with rate adjustment to replicate the individual plasma glucose excursion observed during gastric glucose administration on test day 1.

Study summary

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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
Accepted
Inclusion Criteria: Group 1: * Age 18-75 years * BMI 18.5-25 kg/m² * Normal glucose tolerance (Fasting glucose \< 5.6 mmol/L) Group 2: * Age and sex-matched with group 1 * BMI≥30 kg/m² * Impaired glucose tolerance (Fasting glucose 5.6 - 6.9 mmol/L) Exclusion Criteria: * 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) * Known serious chronic disease, including but not limited to: * Heart disease * Anemia (hemoglobin \<7.0 mmol/L for women, \<8.0 mmol/L for men) * Renal impairment (eGFR \<60 mL/min/1.73m²) * Hepatic impairment (ALT or AST \>3 times upper limit of normal) * Known monogenic obesity * Substance abuse (current or within the past year) * Previous bariatric surgery * Contraindications to study procedures, including: * Esophageal or nasal obstruction (e.g. tumors, strictures) * Coagulopathy * History of skull base trauma * Esophageal varices * Hiatal hernia * Claustrophobia * Inability to comply with MRI requirements (e.g. remaining still) * Presence of non-removable magnetic objects incompatible with MRI * Any other condition or circumstance that, in the opinion of the study physician, may compromise safe participation in the study. Exclusion criteria for women: * Pregnancy, breastfeeding, or wish to become pregnant during the study period * Women of childbearing potential not using adequate contraception * Women using hormonal contraception (oral contraceptives, progestin- containing implants or hormonal intrauterine device.)

Primary outcome measure(s)

  • Hypothalamic response to glucose ingestion during GLP-1 receptor blockade compared with saline — During the MRI scan on three test days
    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.
  • Hypothalamic response to glucose ingestion during GLP-1 infusion compared with saline — During the MRI scan on three test days
    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.

Trial sites (1)

FacilityCityRegionStatus
University of Copenhagen, Department of Biomedical Sciences Copenhagen Denmark

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07854886 on ClinicalTrials.gov ↗ ← All trials in Denmark