ObesityNCT04186026
Co-infusion of Neurotensin and GLP-1 Effects on Appetite and Food Intake.
A study testing Saline + saline, Neurotensin + saline and GLP-1 + saline in people with Obesity, run by University of Copenhagen at 2 sites in Denmark.
Trial summary
Co-infusion of Neurotensin and GLP-1 Effects on Appetite and Food Intake. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Saline + saline, Neurotensin + saline and GLP-1 + saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 2 sitesDenmark
- Study dates
- 1 Oct 2019to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Informed consent
- Above 18 years of age
- Normal hemoglobin concentration
- 28<BMI<40 kg/m2
Who cannot join
- Diabetes mellitus
- Truncal vagotomy
- Resection of intestine (apart from appendectomy)
- Tobaccos use
- Nephropathy (serum-creatinin>130 micromolar or/and albuminuria)
- Liver disease (Alanine transaminase or/and aspartate transaminase>2 times normal range.)
Show all 9Show fewer
- Treatment with medication that cannot be paused in 12 hours
- Allergy towards latex or plastic
- Bleeding disorder
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites, 2 recruiting
- Recruiting
University of Copenhagen, Department of Biomedical Scienses
Copenhagen, 2200
Birgitte Holst, Professor, +4521487699, holst@sund.ku.dk
- Recruiting
Copenhagen University Hospital Hvidovre
Copenhagen, 2650
Sten Madsbad, Professor, +4521691911, sten.madsbad@regionh.dk
Sten Madsbad, Professor
About this study
Official title: Effect of Combination of the Gut Hormones Neurotensin and GLP-1 on Physiological Regulation of Appetite and Food Intake
Co-infusion of Neurotensin and GLP-1 Effects on Appetite and Food Intake.
Read the detailed description
Neurotensin (NT), a gut hormone and neuropeptide, and GLP-1, as well a gut hormone, increases in circulation after bariatric surgery in rodents and humans and inhibit food intake in mice.
Studies in rodents have shown that a GLP-1 receptor agonist and long acting neurotensin inhibit food intake.
This study investigates whether the synergistic anorexic effects of neurotensin and GLP-1 agonism suggested by animal studies can be translated.
- Conditions
- Obesity
- Being tested
- Saline + saline, Neurotensin + saline, GLP-1 + saline, GLP-1 + Neurotensin
- Keywords
- Neurotensin, Glucagon like peptide-1 (GLP-1)
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saline + salineOther
Double saline infusion followed by an ad libitum meal
Neurotensin + salineOther
Neurotensin + saline infusion followed by an ad libitum meal
GLP-1 + salineOther
GLP-1 + saline infusion followed by an ad libitum meal
GLP-1 + NeurotensinOther
GLP-1 + Neurotensin infusion followed by an ad libitum meal
| Study group | Role | What they receive |
|---|---|---|
| Saline+Saline | Other | Not described Receives: Other: Saline + saline |
| Neurotensin+Saline | Other | Not described Receives: Other: Neurotensin + saline |
| GLP-1+Saline | Other | Not described Receives: Other: GLP-1 + saline |
| Neurotensin + GLP-1 | Other | Not described Receives: Other: GLP-1 + Neurotensin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ad-libitum food intake
Neurotensin (NT), saline, GLP-1 and GLP-1+Neurotensin will be infused on four occasions in random order, double blinded. After 2h of infusion an ad libitum meal will be served. When the meal is completed food intake will be determined by weighing the leftovers.
Measured: 120 min
Secondary outcomes (12)
Appetite and gastrointestinal sensations
Using visual analogue scales (VAS) the effect of infusions and meals will be documented.
Ad libitum meals will also be evaluated using VAS.
Measured: -60, -30, 0, 30, 60, 90, 120, 150 and 180 min
Plasma glucose
Bed-side measurements of plasma glucose
Measured: -60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 165 and 180 min
Neurotensin
Plasma analysis
Measured: -60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 165 and 180 min
GLP-1
Plasma analysis
Measured: -60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 165 and 180 min
Insulin
Serum analysis
Measured: -60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 165 and 180 min
C-peptide
Serum analysis
Measured: -60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 165 and 180 min
Bile acids
Plasma analysis
Measured: -60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 165 and 180 min
Ghrelin
Plasma analysis
Measured: -60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 165 and 180 min
Peptide YY (PYY)
Plasma analysis
Measured: -60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 165 and 180 min
Leptin
Plasma analysis
Measured: -60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 165 and 180 min
Metabolomics
Plasma analysis
Measured: -60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 165 and 180 min
Proteomics
Plasma analysis
Measured: -60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 165 and 180 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2019
- Study start1 Oct 2019
- Primary completion10 Jun 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe 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
- Participants will be studied on multiple occasions (4 days) in a randomised and double blinded fashion.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Hvidovre
- Responsible party
- Principal investigator, Birgitte Holst, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04186026
- Sponsor's protocol ID
- 514-0386/19-3000
- Status last verified
- May 2023
- First submitted
- 26 Nov 2019
- Last updated
- 17 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Combination of the Gut Hormones Neurotensin and GLP-1 on Physiological Regulation of Appetite and Food Intake
- ClinicalTrials.gov ID
- NCT04186026
- Acronym / sponsor ID
- 514-0386/19-3000
- Conditions
- Obesity
- Keywords
- Neurotensin, Glucagon like peptide-1 (GLP-1)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Hvidovre
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 10 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 4 Dec 2019 (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.
Co-infusion of Neurotensin and GLP-1 Effects on Appetite and Food Intake.
Detailed description
Neurotensin (NT), a gut hormone and neuropeptide, and GLP-1, as well a gut hormone, increases in circulation after bariatric surgery in rodents and humans and inhibit food intake in mice.
Studies in rodents have shown that a GLP-1 receptor agonist and long acting neurotensin inhibit food intake.
This study investigates whether the synergistic anorexic effects of neurotensin and GLP-1 agonism suggested by animal studies can be translated.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Participants will be studied on multiple occasions (4 days) in a randomised and double blinded fashion.
| Arm | Type | Receives |
|---|---|---|
| Saline+Saline | Other | Other: Saline + saline |
| Neurotensin+Saline | Other | Other: Neurotensin + saline |
| GLP-1+Saline | Other | Other: GLP-1 + saline |
| Neurotensin + GLP-1 | Other | Other: GLP-1 + Neurotensin |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Informed consent
- Above 18 years of age
- Normal hemoglobin concentration
- 28<BMI<40 kg/m2
Key exclusion criteria (9 listed)
- Diabetes mellitus
- Truncal vagotomy
- Resection of intestine (apart from appendectomy)
- Tobaccos use
- Nephropathy (serum-creatinin>130 micromolar or/and albuminuria)
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 |
|---|---|---|
| Saline + salineDouble saline infusion followed by an ad libitum meal | Other | Saline+Saline |
| Neurotensin + salineNeurotensin + saline infusion followed by an ad libitum meal | Other | Neurotensin+Saline |
| GLP-1 + salineGLP-1 + saline infusion followed by an ad libitum meal | Other | GLP-1+Saline |
| GLP-1 + NeurotensinGLP-1 + Neurotensin infusion followed by an ad libitum meal | Other | Neurotensin + GLP-1 |
Primary outcome
Ad-libitum food intake
Time frame: 120 min
Neurotensin (NT), saline, GLP-1 and GLP-1+Neurotensin will be infused on four occasions in random order, double blinded. After 2h of infusion an ad libitum meal will be served. When the meal is completed food intake will be determined by weighing the leftovers.
12 secondary outcomes
Appetite and gastrointestinal sensations
Time frame: -60, -30, 0, 30, 60, 90, 120, 150 and 180 min
Plasma glucose
Time frame: -60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 165 and 180 min
Neurotensin
Time frame: -60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 165 and 180 min
GLP-1
Time frame: -60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 165 and 180 min
Insulin
Time frame: -60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 165 and 180 min
C-peptide
Time frame: -60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 165 and 180 min
Bile acids
Time frame: -60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 165 and 180 min
Ghrelin
Time frame: -60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 165 and 180 min
Peptide YY (PYY)
Time frame: -60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 165 and 180 min
Leptin
Time frame: -60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 165 and 180 min
Metabolomics
Time frame: -60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 165 and 180 min
Proteomics
Time frame: -60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 165 and 180 min
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Saline + saline, Neurotensin + saline and GLP-1 + saline in people with Obesity, run by University of Copenhagen at 2 sites in Denmark.
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 4 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 17 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Birgitte Holst, PhD, Professor (+4521487699, holst@sund.ku.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ad-libitum food intake (time frame: 120 min). 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 17 May 2023.