Normal WeightNCT06487832
Effect of GLP1 Receptor Agonist on Brain Insulin Responsiveness
A study testing Subcutaneous GLP1-RA in people with Normal Weight and Overweight and Obesity, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
The overarching goal of the current study is to investigate the effect of GLP-1 on brain insulin responsiveness in a randomized, single-blinded, within subject cross-over study design. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Normal Weight, Overweight and Obesity, Insulin Sensitivity
- What is being tested?
- Subcutaneous GLP1-RA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jul 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI between 18.5 and 24.9 kg/m2; and between 27.5 kg/m2 and 40 kg/m2
- Written consent to participate in the study
- Written consent to be informed about incidental findings
Who cannot join
- Type 1 or type 2 diabetes, LADA, MODY, or cardiovascular diseases such as chronic heart failure, myocardial infarction, status post stroke
- BMI < 18.5 or > 40 kg/m2
- Persons who cannot legally give consent
- Pregnancy or lactation
- History of severe mental or somatic disorders including neurological diseases (incl. epileptic seizures)
- Taking psychotropic drugs
Show all 27Show fewer
- Chronic diseases or medication that influence glucose metabolism
- Regular use of analgesic drugs
- Previous bariatric surgery
- Known allergy against one or more of the used agents
- Acute infection and/or antibiotic treatment within the last 4 weeks
- Hemoglobin values less than 10.5 g/dl for women, less than 11.5 g/dl for men
- Other diseases that in the opinion of the investigator may jeopardize the success of the study or indicate a risk to the volunteer
- Participation in a lifestyle intervention study or a pharmaceutical study within the last 30 days
- Metal implants which cannot be removed as pacemakers, artificial heart valve, electrical devices as insulin pumps, large tattoos, retainer over more than 4 teeth, contraceptive coil, implanted magnetic metal parts as screws or plates after a surgery
- Persons with claustrophobia
- Persons with tinnitus
- Weight loss or gain of >5% in the last 3 months
- Pancreatic diseases
- History or family history of multiple endocrine neoplasia (MEN2) or medullary thyroid cancer
- History of malignant thyroid disease
- History of malignant disease in the past 5 years
- Surgery in the last three months
- Chronic tobacco use of more than 10 cigarettes/day
- Women who do not consent to refrain from breastfeeding until 2 months after the end of the study
- Women of childbearing age who do not consent to use safe method of contraception from 28 days before until 2 months after the end of the study or refrain from heterosexual intercourse during this time
- Women of childbearing age who do not consent to take a pregnancy test
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Clinic Tubingen, Department of Internal Medicine IV
Tübingen, 72076
Stephanie Kullmann, PhD, 0049707129 ext. 87703, stephanie.kullmann@med.uni-tuebingen.de
About this study
Official title: Impact of the Incretin System on Brain Insulin Sensitivity in Humans with Normal Weight, Overweight and Obesity
The overarching goal of the current study is to investigate the effect of GLP-1 on brain insulin responsiveness in a randomized, single-blinded, within subject cross-over study design. To this end, investigators will compare the effect of the administration of semaglutide versus placebo, followed by an fMRI with administration of intranasal insulin or placebo.
Read the detailed description
Investigate the effect of the GLP1 receptor agonist (i.e. 0.25 mg semaglutide) vs. placebo on the brain using functional magnetic resonance imaging (fMRI) in combination with 160IU intranasal insulin vs. placebo administration in healthy male and female participants of normal-weight and overweight/obesity. Participants will furthermore undergo tasks that assess cognitive functions and eating behavior. Brain insulin responsiveness (primary outcome) is defined as the cerebral response to intranasal insulin compared to placebo by means of cerebral blood flow and resting-state BOLD measurements. Secondary outcomes include diffusion weighted imaging, neural food cue reactivity, cognitive functions and metabolic predictors.
- Being tested
- Subcutaneous GLP1-RA, Subcutaneous placebo
- Keywords
- GLP-1, Brain, functional magnetic resonance imaging, Semaglutide
- Medical subject headings
- Overweight, Obesity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subcutaneous GLP1-RAOther
Subcutaneous administration of semaglutide
Subcutaneous placeboOther
Subcutaneous administration of NaCl
| Study group | Role | What they receive |
|---|---|---|
| GLP-1 | Experimental | Acute administration of 0.25 mg semaglutide (0.19 ml) Receives: Other: Subcutaneous GLP1-RA |
| Placebo | Placebo comparator | Acute administration of 0.19 ml NaCl Receives: Other: Subcutaneous placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral response after insulin compared to placebo nasal spray
Resting-state cerebral blood flow and BOLD-fMRI response from before to 30 min after nasal spray administration
Measured: 24 hours after semaglutide or placebo administration
Secondary outcomes (6)
Neural food-cue reactivity after insulin compared to placebo nasal spray
BOLD-fMRI response to food cues 30 min after nasal spray administration
Measured: 24 hours after semaglutide or placebo administration
Diffusion-weighted imaging (DWI)
Diffusion weighted parameter based on MRI measurements
Measured: 24 hours after semaglutide or placebo administration
Heart rate variability (HRV)
HRV based on ECG measurements
Measured: 24 hours after semaglutide or placebo administration
Change in subjective feeling of hunger and food craving
On a visual analogue scale, subjective feeling of hunger and food craving will be assessed using questionnaires.
Measured: 24 hours after semaglutide or placebo administration
Change in mood
Using a questionnaire, positive and negative affect state will be assessed.
Measured: 24 hours after semaglutide or placebo administration
Performance during cognitive tests
Cambridge Cognition Tests Battery
Measured: 24 hours after semaglutide or placebo administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start1 Jul 2024
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal WeightStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- In a randomized, single-blinded, within subject cross-over design, we will compare cerebral response from before to after intranasal insulin or placebo administration after a single dose of 0.25 mg semaglutide administration versus placebo administration
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andreas L. Birkenfeld, MD, Study director, Institute for Diabetes research and Metabolic Diseases at the University of Tubingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06487832
- Sponsor's protocol ID
- 065/2024BO1
- Status last verified
- Jun 2024
- First submitted
- 27 Jun 2024
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Incretin System on Brain Insulin Sensitivity in Humans with Normal Weight, Overweight and Obesity
- ClinicalTrials.gov ID
- NCT06487832
- Acronym / sponsor ID
- 065/2024BO1
- Keywords
- GLP-1, Brain, functional magnetic resonance imaging, Semaglutide
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 5 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overarching goal of the current study is to investigate the effect of GLP-1 on brain insulin responsiveness in a randomized, single-blinded, within subject cross-over study design. To this end, investigators will compare the effect of the administration of semaglutide versus placebo, followed by an fMRI with administration of intranasal insulin or placebo.
Detailed description
Investigate the effect of the GLP1 receptor agonist (i.e. 0.25 mg semaglutide) vs. placebo on the brain using functional magnetic resonance imaging (fMRI) in combination with 160IU intranasal insulin vs. placebo administration in healthy male and female participants of normal-weight and overweight/obesity. Participants will furthermore undergo tasks that assess cognitive functions and eating behavior. Brain insulin responsiveness (primary outcome) is defined as the cerebral response to intranasal insulin compared to placebo by means of cerebral blood flow and resting-state BOLD measurements. Secondary outcomes include diffusion weighted imaging, neural food cue reactivity, cognitive functions and metabolic predictors.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- In a randomized, single-blinded, within subject cross-over design, we will compare cerebral response from before to after intranasal insulin or placebo administration after a single dose of 0.25 mg semaglutide administration versus placebo administration
| Arm | Type | Receives |
|---|---|---|
| GLP-1 | Experimental | Other: Subcutaneous GLP1-RAAcute administration of 0.25 mg semaglutide (0.19 ml) |
| Placebo | Placebo comparator | Other: Subcutaneous placeboAcute administration of 0.19 ml NaCl |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- BMI between 18.5 and 24.9 kg/m2; and between 27.5 kg/m2 and 40 kg/m2
- Written consent to participate in the study
- Written consent to be informed about incidental findings
Key exclusion criteria (27 listed)
- Type 1 or type 2 diabetes, LADA, MODY, or cardiovascular diseases such as chronic heart failure, myocardial infarction, status post stroke
- BMI < 18.5 or > 40 kg/m2
- Persons who cannot legally give consent
- Pregnancy or lactation
- History of severe mental or somatic disorders including neurological diseases (incl. epileptic seizures)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Subcutaneous GLP1-RASubcutaneous administration of semaglutide | Other | GLP-1 |
| Subcutaneous placeboSubcutaneous administration of NaCl | Other | Placebo |
Primary outcome
Cerebral response after insulin compared to placebo nasal spray
Time frame: 24 hours after semaglutide or placebo administration
Resting-state cerebral blood flow and BOLD-fMRI response from before to 30 min after nasal spray administration
6 secondary outcomes
Neural food-cue reactivity after insulin compared to placebo nasal spray
Time frame: 24 hours after semaglutide or placebo administration
Diffusion-weighted imaging (DWI)
Time frame: 24 hours after semaglutide or placebo administration
Heart rate variability (HRV)
Time frame: 24 hours after semaglutide or placebo administration
Change in subjective feeling of hunger and food craving
Time frame: 24 hours after semaglutide or placebo administration
Change in mood
Time frame: 24 hours after semaglutide or placebo administration
Performance during cognitive tests
Time frame: 24 hours after semaglutide or placebo administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Normal Weight
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
Not yet recruitingPhase 1
A Study of Zovaglutide (ZT002 Injection) in Participants With Hepatic Impairment and Healthy Participants
Overweight, Obesity
RecruitingPhase 4
A Study to Investigate the Effectiveness of Tirzepatide (LY3298176) Following Initiation of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Plaque PsO and Obesity or Overweight in Clinical Practice (TOGETHER AMPLIFY-PsO)
Psoriasis, Overweight or Obesity
Recruiting
Hypothalamic GLP-1 Response in Healthy Weight and Obesity
Obesity, Normal Weight
Not yet recruitingPhase 2
Semaglutide for Weight Management During Hormone Therapy for Early Breast Cancer
Breast Cancer (Early Breast Cancer), Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andreas L. Birkenfeld, MD study director
Institute for Diabetes research and Metabolic Diseases at the University of Tubingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subcutaneous GLP1-RA in people with Normal Weight and Overweight and Obesity, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephanie Kullmann, PhD (0049707129 ext. 87703, stephanie.kullmann@med.uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebral response after insulin compared to placebo nasal spray (time frame: 24 hours after semaglutide or placebo administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.