Insulin SensitivityNCT01847456
Influence of Brain Insulin Sensitivity on Peripheral Insulin Sensitivity
A study testing human insulin as nasal spray in people with Insulin Sensitivity, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
The researchers will investigate if brain insulin action influences peripheral insulin sensitivity in healthy humans. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Insulin Sensitivity
- What is being tested?
- human insulin as nasal spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2013to Nov 2013
- 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 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI < 28 kg/m2
- normal HbA1c
- healthy volunteers
Who cannot join
- Heparin induced thrombocytopenia (HIT)
- metal implants
- cardial diseases
- anemia
- patients taking any kind of drugs
Trial locations and contacts
1 site in 1 country.
About this study
The researchers will investigate if brain insulin action influences peripheral insulin sensitivity in healthy humans.
- Conditions
- Insulin Sensitivity
- Being tested
- human insulin as nasal spray, Placebo
- Keywords
- whole body insulin sensitivity, insulin action in the brain
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
human insulin as nasal sprayDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| insulin nasal spray | Experimental | 160 Units of human insulin as nasal spray Receives: Drug: human insulin as nasal spray |
| Placebo nasal spray | Placebo comparator | Nasalspray containing placebo solution Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensitivity as measured by clamp
We will measure insulin sensitivity by hyperinsulinemic euglycemic clamp before and after nasal spray application. We will compare the post-spray insulin sensitivity between the two condition (insulin nasal spray vs placebo nasal spray). Furthermore, we will compare insulin sensitivity before and after nasal insulin application.
Measured: 45 minutes to 120 minutes post nasal spray
Secondary outcomes (1)
Autonomous nervous system activity
Activity of the autonomous nervous system will be estimated by heart rate variability in ECG. We will compare the post-spray autonomous nervous system activity between the two condition (insulin nasal spray vs placebo nasal spray). Furthermore, we will compare autonomous nervous system activity before and after nasal insulin application.
Measured: 45 to 120 minutes post spray
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2013 (estimated)
- Study startApr 2013
- Primary completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Insulin SensitivityStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, andreas fritsche, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01847456
- Sponsor's protocol ID
- SFB 997 A01 WP7
- Status last verified
- Dec 2013
- First submitted
- 28 Apr 2013
- Last updated
- 23 Dec 2013
- Results posted
- No
Publications
Heni M, Wagner R, Kullmann S, Veit R, Mat Husin H, Linder K, Benkendorff C, Peter A, Stefan N, Haring HU, Preissl H, Fritsche A. Central insulin administration improves whole-body insulin sensitivity via hypothalamus and parasympathetic outputs in men. Diabetes. 2014 Dec;63(12):4083-8. doi: 10.2337/db14-0477. Epub 2014 Jul 15.
PubMed 25028522
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Brain Insulin Sensitivity on Peripheral Insulin Sensitivity
- ClinicalTrials.gov ID
- NCT01847456
- Acronym / sponsor ID
- SFB 997 A01 WP7
- Conditions
- Insulin Sensitivity
- Keywords
- whole body insulin sensitivity, insulin action in the brain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Nov 2013 (actual)
- First posted
- 6 May 2013 (estimated)
- 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 researchers will investigate if brain insulin action influences peripheral insulin sensitivity in healthy humans.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| insulin nasal spray | Experimental | Drug: human insulin as nasal spray160 Units of human insulin as nasal spray |
| Placebo nasal spray | Placebo comparator | Drug: PlaceboNasalspray containing placebo solution |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- BMI < 28 kg/m2
- normal HbA1c
- healthy volunteers
Key exclusion criteria (5 listed)
- Heparin induced thrombocytopenia (HIT)
- metal implants
- cardial diseases
- anemia
- patients taking any kind of drugs
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 |
|---|---|---|
| human insulin as nasal spray | Drug | insulin nasal spray |
| Placebo | Drug | Placebo nasal spray |
Primary outcome
Insulin sensitivity as measured by clamp
Time frame: 45 minutes to 120 minutes post nasal spray
We will measure insulin sensitivity by hyperinsulinemic euglycemic clamp before and after nasal spray application. We will compare the post-spray insulin sensitivity between the two condition (insulin nasal spray vs placebo nasal spray). Furthermore, we will compare insulin sensitivity before and after nasal insulin application.
1 secondary outcome
Autonomous nervous system activity
Time frame: 45 to 120 minutes post spray
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 23 Dec 2013.
- Derived from this study: PubMed 25028522Heni M, Wagner R, Kullmann S, Veit R, Mat Husin H, Linder K, Benkendorff C, Peter A, Stefan N, Haring HU, Preissl H, Fritsche A. Central insulin administration improves whole-body insulin sensitivity via hypothalamus and parasympathetic outputs in men. Diabetes. 2014 Dec;63(12):4083-8. doi: 10.2337/db14-0477. Epub 2014 Jul 15.
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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 human insulin as nasal spray in people with Insulin Sensitivity, 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 5 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 23 Dec 2013. 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?
Insulin sensitivity as measured by clamp (time frame: 45 minutes to 120 minutes post nasal spray). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01847456, which also lists 1 linked publication.
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 23 Dec 2013.