ObesityNCT04038086
Transport of Satiety Factors Into the CSF
A study testing oral glucose tolerance test, circadian rhythm and effect of insulin on peptide transport in people with Obesity, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
The blood-brain barrier regulates the passage of peripheral built appetite-suppressing hormones from the blood to the brain and informs the brain about the nutritional- and energy status. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity
- What is being tested?
- oral glucose tolerance test, circadian rhythm and effect of insulin on peptide transport
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 15 Jul 2019to 1 Jun 2023
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with cerebrospinal fluid drainage
Who cannot join
- Women during pregnancy and lactation
- Participation in other interventional clinical trials
- severe infection within the last 4 months
- intake of central effective substances which may interact with the transport processes to be investigated
- hypersensitivity to any of the substances used
- diabetes mellitus
Show all 9Show fewer
- Patients with CSF results indicative of infectious diseases within the central nervous system
- subjects with hemoglobin Hb <10 g / dl
- Patients with a neurosurgical disorder suspected of having a blood-brain barrier disorder
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University of Tuebingen, Department of Internal Medicine IV
Tübingen, 72076
Martin Heni, MD, +49 7071 29 82714, martin.heni@med.uni-tuebingen.de
Andreas Fritsche, MD, +49 7071 29 82714, andreas.fritsche@med.uni-tuebingen.de
About this study
Official title: Transport Von Peripheren Sättigungshormonen in Das Zentrale Nervensystem
The blood-brain barrier regulates the passage of peripheral built appetite-suppressing hormones from the blood to the brain and informs the brain about the nutritional- and energy status.
The aim of this study is to investigate in which extent the hormones are able to overcome the blood-brain barrier and how long it takes after food intake. Relating thereto indications to the effect of peripheral hormones in the central nervous system and the role of these hormones in the development of overweight are provided.
Read more
In this study 30 patients (10 per intervention group) will be recruited. The patients are hospitalized in the local neurosurgery and they have a CSF-drainage due to their neurological primary disease or due to neurosurgical interventions. The patients are examined in each case on the same day.
Simultaneous samplings of blood and CSF are taken from 10 patients after an oral glucose tolerance test. These interventions are carried out to investigate in which extent the appetite-suppressing hormones (e.g. Leptin, Insulin, GLP 1 and Glucagon) reach the liquor and so the central nervous system.
In order to understand the temporal sequence, simultaneous samplings of blood and CSF are taken from 10 other patients at certain points throughout the day.
In a further group of 10 patients will be investigated how the central effective insulin modulates the transport of the other appetite-suppressing hormones. Therefore samplings of blood and CSF are investigated before and after intranasal insulin administration.
- Conditions
- Obesity
- Being tested
- oral glucose tolerance test, circadian rhythm, effect of insulin on peptide transport
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral glucose tolerance testDiagnostic test
Participants will undergo an 75 gram oral glucose tolerance test. Blood and CSF will be collected in the fasting state before the test and every 30 minutes throughout the test which lasts for 2 hours.
circadian rhythmOther
Blood and CSF will be collected five times throughout the day.
effect of insulin on peptide transportDrug
Blood and CSF will be collected in the fasting state and 15, 30, 60, 120 und 240 min after administration of 160 U of human insulin as nasal spray.
| Study group | Role | What they receive |
|---|---|---|
| oral glucose tolerance test | Experimental | Not described Receives: Diagnostic Test: oral glucose tolerance test |
| circadian rhythm | Other | Not described Receives: Other: circadian rhythm |
| effect of insulin on peptide transport | Experimental | Not described Receives: Drug: effect of insulin on peptide transport |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin transport into the CSF
Insulin will be measured in serum and CSF and the ratio will be calculated.
Measured: Sample collection will be from 0 to 120 minutes in Arm 1, 18 hours in Arm 2, and 0 to 240 minutes in Arm 3
Secondary outcomes (5)
Transport of proglucagon cleavage products into the CSF
Proglucagon cleavage products will be measured in serum and CSF and the ratio will be calculated.
Measured: Sample collection will be from 0 to 120 minutes in Arm 1, 18 hours in Arm 2, and 0 to 240 minutes in Arm 3
Transport of FGF21 and FGF23 into the CSF
FGF21 and FGF23 will be measured in serum and CSF and the ratio will be calculated.
Measured: Sample collection will be from 0 to 120 minutes in Arm 1, 18 hours in Arm 2, and 0 to 240 minutes in Arm 3
Ghrelin transport into the CSF
Ghrelin will be measured in serum and CSF and the ratio will be calculated.
Measured: Sample collection will be from 0 to 120 minutes in Arm 1, 18 hours in Arm 2, and 0 to 240 minutes in Arm 3
PYY transport into the CSF
PYY will be measured in serum and CSF and the ratio will be calculated.
Measured: Sample collection will be from 0 to 120 minutes in Arm 1, 18 hours in Arm 2, and 0 to 240 minutes in Arm 3
Leptin transport into the CSF
Leptin will be measured in serum and CSF and the ratio will be calculated.
Measured: Sample collection will be from 0 to 120 minutes in Arm 1, 18 hours in Arm 2, and 0 to 240 minutes in Arm 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2019
- Study start15 Jul 2019
- Primary completion31 Dec 2022 (estimated)
- Study completion1 Jun 2023 (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 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04038086
- Sponsor's protocol ID
- 397/2019BO1
- Status last verified
- Mar 2022
- First submitted
- 15 Jul 2019
- Last updated
- 28 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will not be able to share patient level data due to data protection regulations.
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transport Von Peripheren Sättigungshormonen in Das Zentrale Nervensystem
- ClinicalTrials.gov ID
- NCT04038086
- Acronym / sponsor ID
- 397/2019BO1
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 15 Jul 2019 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 30 Jul 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.
The blood-brain barrier regulates the passage of peripheral built appetite-suppressing hormones from the blood to the brain and informs the brain about the nutritional- and energy status.
The aim of this study is to investigate in which extent the hormones are able to overcome the blood-brain barrier and how long it takes after food intake. Relating thereto indications to the effect of peripheral hormones in the central nervous system and the role of these hormones in the development of overweight are provided.
In this study 30 patients (10 per intervention group) will be recruited. The patients are hospitalized in the local neurosurgery and they have a CSF-drainage due to their neurological primary disease or due to neurosurgical interventions. The patients are examined in each case on the same day.
Simultaneous samplings of blood and CSF are taken from 10 patients after an oral glucose tolerance test. These interventions are carried out to investigate in which extent the appetite-suppressing hormones (e.g. Leptin, Insulin, GLP 1 and Glucagon) reach the liquor and so the central nervous system.
In order to understand the temporal sequence, simultaneous samplings of blood and CSF are taken from 10 other patients at certain points throughout the day.
In a further group of 10 patients will be investigated how the central effective insulin modulates the transport of the other appetite-suppressing hormones. Therefore samplings of blood and CSF are investigated before and after intranasal insulin administration.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| oral glucose tolerance test | Experimental | Diagnostic Test: oral glucose tolerance test |
| circadian rhythm | Other | Other: circadian rhythm |
| effect of insulin on peptide transport | Experimental | Drug: effect of insulin on peptide transport |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with cerebrospinal fluid drainage
Key exclusion criteria (9 listed)
- Women during pregnancy and lactation
- Participation in other interventional clinical trials
- severe infection within the last 4 months
- intake of central effective substances which may interact with the transport processes to be investigated
- hypersensitivity to any of the substances used
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 |
|---|---|---|
| oral glucose tolerance testParticipants will undergo an 75 gram oral glucose tolerance test. Blood and CSF will be collected in the fasting state before the test and every 30 minutes throughout the test which lasts for 2 hours. | Diagnostic test | oral glucose tolerance test |
| circadian rhythmBlood and CSF will be collected five times throughout the day. | Other | circadian rhythm |
| effect of insulin on peptide transportBlood and CSF will be collected in the fasting state and 15, 30, 60, 120 und 240 min after administration of 160 U of human insulin as nasal spray. | Drug | effect of insulin on peptide transport |
Primary outcome
Insulin transport into the CSF
Time frame: Sample collection will be from 0 to 120 minutes in Arm 1, 18 hours in Arm 2, and 0 to 240 minutes in Arm 3
Insulin will be measured in serum and CSF and the ratio will be calculated.
5 secondary outcomes
Transport of proglucagon cleavage products into the CSF
Time frame: Sample collection will be from 0 to 120 minutes in Arm 1, 18 hours in Arm 2, and 0 to 240 minutes in Arm 3
Transport of FGF21 and FGF23 into the CSF
Time frame: Sample collection will be from 0 to 120 minutes in Arm 1, 18 hours in Arm 2, and 0 to 240 minutes in Arm 3
Ghrelin transport into the CSF
Time frame: Sample collection will be from 0 to 120 minutes in Arm 1, 18 hours in Arm 2, and 0 to 240 minutes in Arm 3
PYY transport into the CSF
Time frame: Sample collection will be from 0 to 120 minutes in Arm 1, 18 hours in Arm 2, and 0 to 240 minutes in Arm 3
Leptin transport into the CSF
Time frame: Sample collection will be from 0 to 120 minutes in Arm 1, 18 hours in Arm 2, and 0 to 240 minutes in Arm 3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2022.
- Individual participant dataSharing planned: No. We will not be able to share patient level data due to data protection regulations.
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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.
University of Tuebingen, Department of Internal Medicine IV
Tübingen, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oral glucose tolerance test, circadian rhythm and effect of insulin on peptide transport in people with 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 1 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 28 Mar 2022. 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. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin transport into the CSF (time frame: Sample collection will be from 0 to 120 minutes in Arm 1, 18 hours in Arm 2, and 0 to 240 minutes in Arm 3). 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 28 Mar 2022.