Diabetes Mellitus, Type 2NCT03637075
Raclopride-PET/MRT
A study testing intranasal insulin in people with Diabetes Mellitus, Type 2, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
Cerebral insulin resistance plays an important role in the development of obesity and diabetes mellitus type 2. The aim of this project is to examine the effect of human nasal insulin on the dopaminergic system. Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- intranasal insulin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteGermany
- Study dates
- 20 Feb 2017to 31 Dec 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 20 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures.
- Intake of any medication
- HbA1C <6%
- BMI 20-25 kg/m²
- Clinical routine blood parameters within the normal ranges
- All participants must agree to get informed of unexpected detected, clinical relevant findings.
Who cannot join
- Acute diseases such as infections (e.g.)
- Any relevant cardiovascular disease
- Any surgery within the last three months
- Any neurologic or psychiatric disease
- Known allergies
- Hb < 13 g/dl
- Presence of any contraindication for the conduct of an MRI investigation, such as cardiac pacemakers, ferromagnetic haemostatic clips in the central nervous system, metallic splinters in the eye, ferromagnetic or electronically operated active devices like automatic cardioverter defibrillators, cochlear implants, insulin pumps and nerve stimulators, prosthetic heart valves etc.
- Claustrophobia
Trial locations and contacts
1 site in 1 country.
Germany1 site
University of Tuebingen, Department of Internal Medicine IV
Tübingen, 72076
About this study
Official title: Characterization of Insulin Action and Dopamine-signaling in the Human Brain of Normal Weight and Obese Subjects by [11C]-Raclopride-PET/MRT
Cerebral insulin resistance plays an important role in the development of obesity and diabetes mellitus type 2. The aim of this project is to examine the effect of human nasal insulin on the dopaminergic system. Therefore, characteristics of cerebral dopamine receptors before and after administration of nasal insulin vs. placebo shall be analyzed in a randomized way. Moreover, the investigators plan to examine the insulin action on cortical and subcortical activation in humans and the interaction of dopamine metabolism with [11C]-Raclopride-PET/MRI. By performing fMRI measurements, insulin sensitivity of the central nervous system can be investigated simultaneously. Recruiting is planed as a two-step process.First 12 normal-weight (BMI 20-25 kg/m²) men should be examined. If first results show a insulin-dependent effect on the availability of dopamine receptors in the human brain, recruitment of 12 overweight men will get started.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- intranasal insulin, Placebo
- Keywords
- Diabetes mellitus, Type 2, cerebral insulin resistance, insulin action in the human brain, dopamine signalling
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intranasal insulinOther
intranasal administration of insulin (160 IU)
PlaceboOther
placebo intranasal administration
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Intranasal placebo administration Receives: Other: Placebo |
| Intranasal insulin | Active comparator | Intranasal insulin administration Receives: Other: intranasal insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of nasal insulin vs. placebo on the insulin sensitivity of the human brain as well as effects on regional availability of dopamine receptors.
assessed by fMRI (insulin sensitivity of the brain measured as change in regional brain activity and Raclopride-PET/MRT (regional dopamine receptor availability).
Measured: 0-60 min
Secondary outcomes (6)
Differences between normalweight and overweight subjects regarding insulin sensitivity and availability of dopamine receptors
assessed by fMRI and Raclopride-PET/MRT
Measured: 0 - 60 min
Effects of nasal insulin vs. placebo on changes in plasma insulin levels
assessed by blood sampling after application.
Measured: 0 - 60min
Effects of nasal insulin vs. placebo on changes in plasma glucose levels
assessed by blood sampling after application.
Measured: 0 - 60min
Effects of nasal insulin vs. placebo on changes in FFA levels
assessed by blood sampling after application.
Measured: 0 - 60min
Effects of nasal insulin vs. placebo on changes in prolactin levels as a proxy for the dopaminergic tonus
assessed by blood sampling after application.
Measured: 0 - 60min
Effects of nasal insulin vs. placebo on changes in autonomic nervous system
assessed by heart rate variability.
Measured: -30 - 60 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study start20 Feb 2017
- Primary completion6 Jun 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- single-blinded, monocentric, prospective crossover study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03637075
- Sponsor's protocol ID
- GK-PET/MR Tü-014
- Status last verified
- May 2024
- First submitted
- 3 Aug 2018
- Last updated
- 14 May 2024
- 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 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Insulin Action and Dopamine-signaling in the Human Brain of Normal Weight and Obese Subjects by [11C]-Raclopride-PET/MRT
- ClinicalTrials.gov ID
- NCT03637075
- Acronym / sponsor ID
- GK-PET/MR Tü-014
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Diabetes mellitus, Type 2, cerebral insulin resistance, insulin action in the human brain, dopamine signalling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 20 Feb 2017 (actual)
- Primary completion
- 6 Jun 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 17 Aug 2018 (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.
Cerebral insulin resistance plays an important role in the development of obesity and diabetes mellitus type 2. The aim of this project is to examine the effect of human nasal insulin on the dopaminergic system. Therefore, characteristics of cerebral dopamine receptors before and after administration of nasal insulin vs. placebo shall be analyzed in a randomized way. Moreover, the investigators plan to examine the insulin action on cortical and subcortical activation in humans and the interaction of dopamine metabolism with [11C]-Raclopride-PET/MRI. By performing fMRI measurements, insulin sensitivity of the central nervous system can be investigated simultaneously. Recruiting is planed as a two-step process.First 12 normal-weight (BMI 20-25 kg/m²) men should be examined. If first results show a insulin-dependent effect on the availability of dopamine receptors in the human brain, recruitment of 12 overweight men will get started.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- single-blinded, monocentric, prospective crossover study
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboIntranasal placebo administration |
| Intranasal insulin | Active comparator | Other: intranasal insulinIntranasal insulin administration |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures.
- Intake of any medication
- HbA1C <6%
- BMI 20-25 kg/m²
- Clinical routine blood parameters within the normal ranges
Key exclusion criteria (8 listed)
- Acute diseases such as infections (e.g.)
- Any relevant cardiovascular disease
- Any surgery within the last three months
- Any neurologic or psychiatric disease
- Known allergies
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 |
|---|---|---|
| intranasal insulinintranasal administration of insulin (160 IU) | Other | Intranasal insulin |
| Placeboplacebo intranasal administration | Other | Placebo |
Primary outcome
Effects of nasal insulin vs. placebo on the insulin sensitivity of the human brain as well as effects on regional availability of dopamine receptors.
Time frame: 0-60 min
assessed by fMRI (insulin sensitivity of the brain measured as change in regional brain activity and Raclopride-PET/MRT (regional dopamine receptor availability).
6 secondary outcomes
Differences between normalweight and overweight subjects regarding insulin sensitivity and availability of dopamine receptors
Time frame: 0 - 60 min
Effects of nasal insulin vs. placebo on changes in plasma insulin levels
Time frame: 0 - 60min
Effects of nasal insulin vs. placebo on changes in plasma glucose levels
Time frame: 0 - 60min
Effects of nasal insulin vs. placebo on changes in FFA levels
Time frame: 0 - 60min
Effects of nasal insulin vs. placebo on changes in prolactin levels as a proxy for the dopaminergic tonus
Time frame: 0 - 60min
Effects of nasal insulin vs. placebo on changes in autonomic nervous system
Time frame: -30 - 60 min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intranasal insulin in people with Diabetes Mellitus, Type 2, 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 6 inclusion and 8 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: finished, as of the sponsor's last update on 14 May 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of nasal insulin vs. placebo on the insulin sensitivity of the human brain as well as effects on regional availability of dopamine receptors. (time frame: 0-60 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 14 May 2024.