Insulin SecretionNCT02870361
Influence of Central Nervous Insulin Sensitivity on Insulin Secretion
A study testing intranasal insulin in people with Insulin Secretion, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
Insulin resistance is a central pathophysiological component of type 2 diabetes and is associated with a high risk of cardiovascular disease. The tissue in which it manifests are mainly muscle, liver, and adipose tissue. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Insulin Secretion
- What is being tested?
- intranasal insulin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2016to Apr 2018
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- HbA1c ≤6.0%
- normal glucose tolerance during 75g oral glucose tolerance test (OGTT)
Who cannot join
- Not removable metal parts in or on the body
- manifest cardiovascular disease
- claustrophobia
- recent surgery (less than 3 months)
- Simultaneous participation in other studies
- Acute disease or infection within the last 4 weeks
Show all 10Show fewer
- neurological and psychiatric disorders
- treatment with centrally acting drugs
- hemoglobin Hb <13g / dl
- Hypersensitivity to any of the substances used
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: Einfluss Der zentralnervösen Insulinsensitivität Auf Die Insulinsekretion
Insulin resistance is a central pathophysiological component of type 2 diabetes and is associated with a high risk of cardiovascular disease. The tissue in which it manifests are mainly muscle, liver, and adipose tissue. Since the transport of glucose to the brain is independent of insulin, this organ has traditionally not been studied in this regard. In animal experiments, however, knockout of the insulin receptor in the brain leads to obesity and peripheral insulin resistance. This finding of insulin action in the brain could also be confirmed in human studies.
The investigators intend to investigate whether central nervous insulin action affects insulin secretion in humans. For this purpose, nasal insulin and placebo are administered 15 minutes before a hyperglycemic hyperinsulinemic clamps, which stimulate insulin secretion. Insulin sensitivity of the brain is measured by a an established protocol with functional magnetic resonance imaging before and after nasal insulin administration.
- Conditions
- Insulin Secretion
- Being tested
- intranasal insulin, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intranasal insulinDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Insulin nasal spray | Active comparator | 160 Units of human insulin as nasal spray Receives: Drug: intranasal insulin |
| Placebo nasal spray | Placebo comparator | Nasal spray containing placebo solution Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin secretion assessed as serum C-peptide levels during a hyperglycemic clamp
Measured: 0-10 min during hyperglycemic clamp and 10-90 min during hyperglycemic clamp
Secondary outcomes (4)
Correlation with brain insulin sensitivity
Correlation of regional brain insulin sensitivity with the change of pancreatic insulin secretion due to central action of insulin. Changes in regional cerebral blood flow from before to after intranasal insulin administration will be assessed by functional magnetresonance imaging (fMRI)
Measured: 15-30 minutes post insulin nasal spray
Differential effects in lean and overweight
Differences in the effect of nasal insulin versus placebo on C-peptide levels during a hyperglycemic clamp between lean and overweight men will be assessed.
Measured: 0-10 min during hyperglycemic clamp and 10-90 min during hyperglycemic clamp
Correlation with autonomous nervous system activity
Correlation of the change in pancreatic insulin secretion by central insulin action with the simultaneous change of the autonomous nervous system (measured by heart rate variability).
Measured: 10 - 150 minutes post nasal spray
Peripheral insulin sensitivity
Effect of nasal insulin versus placebo on peripheral insulin sensitivity assessed by hyperglycemic hyperinsulinemic clamp.
Measured: 10-90 min and 70-90 min during hyperglycemic clamp
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionFeb 2018
- Study completionApr 2018
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 SecretionStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin Heni, MD, Principal investigator, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02870361
- Sponsor's protocol ID
- 086/2016BO1
- Status last verified
- May 2018
- First submitted
- 9 Aug 2016
- Last updated
- 8 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Heni M, Wagner R, Willmann C, Jaghutriz BA, Vosseler A, Kubler C, Hund V, Scheffler K, Peter A, Haring HU, Preissl H, Kullmann S, Fritsche A. Insulin Action in the Hypothalamus Increases Second-Phase Insulin Secretion in Humans. Neuroendocrinology. 2020;110(11-12):929-937. doi: 10.1159/000504551. Epub 2019 Nov 5.
PubMed 31689708
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Einfluss Der zentralnervösen Insulinsensitivität Auf Die Insulinsekretion
- ClinicalTrials.gov ID
- NCT02870361
- Acronym / sponsor ID
- 086/2016BO1
- Conditions
- Insulin Secretion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 17 Aug 2016 (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.
Insulin resistance is a central pathophysiological component of type 2 diabetes and is associated with a high risk of cardiovascular disease. The tissue in which it manifests are mainly muscle, liver, and adipose tissue. Since the transport of glucose to the brain is independent of insulin, this organ has traditionally not been studied in this regard. In animal experiments, however, knockout of the insulin receptor in the brain leads to obesity and peripheral insulin resistance. This finding of insulin action in the brain could also be confirmed in human studies.
The investigators intend to investigate whether central nervous insulin action affects insulin secretion in humans. For this purpose, nasal insulin and placebo are administered 15 minutes before a hyperglycemic hyperinsulinemic clamps, which stimulate insulin secretion. Insulin sensitivity of the brain is measured by a an established protocol with functional magnetic resonance imaging before and after nasal insulin administration.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insulin nasal spray | Active comparator | Drug: intranasal insulin160 Units of human insulin as nasal spray |
| Placebo nasal spray | Placebo comparator | Drug: PlaceboNasal spray containing placebo solution |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- HbA1c ≤6.0%
- normal glucose tolerance during 75g oral glucose tolerance test (OGTT)
Key exclusion criteria (10 listed)
- Not removable metal parts in or on the body
- manifest cardiovascular disease
- claustrophobia
- recent surgery (less than 3 months)
- Simultaneous participation in other studies
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 insulin | Drug | Insulin nasal spray |
| Placebo | Drug | Placebo nasal spray |
Primary outcome
Insulin secretion assessed as serum C-peptide levels during a hyperglycemic clamp
Time frame: 0-10 min during hyperglycemic clamp and 10-90 min during hyperglycemic clamp
4 secondary outcomes
Correlation with brain insulin sensitivity
Time frame: 15-30 minutes post insulin nasal spray
Differential effects in lean and overweight
Time frame: 0-10 min during hyperglycemic clamp and 10-90 min during hyperglycemic clamp
Correlation with autonomous nervous system activity
Time frame: 10 - 150 minutes post nasal spray
Peripheral insulin sensitivity
Time frame: 10-90 min and 70-90 min during hyperglycemic clamp
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 8 May 2018.
- Derived from this study: PubMed 31689708Heni M, Wagner R, Willmann C, Jaghutriz BA, Vosseler A, Kubler C, Hund V, Scheffler K, Peter A, Haring HU, Preissl H, Kullmann S, Fritsche A. Insulin Action in the Hypothalamus Increases Second-Phase Insulin Secretion in Humans. Neuroendocrinology. 2020;110(11-12):929-937. doi: 10.1159/000504551. Epub 2019 Nov 5.
- 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.
Martin Heni, MD principal investigator
University Hospital Tuebingen
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 Insulin Secretion, 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 2 inclusion and 10 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 8 May 2018. 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 secretion assessed as serum C-peptide levels during a hyperglycemic clamp (time frame: 0-10 min during hyperglycemic clamp and 10-90 min during hyperglycemic clamp). 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 NCT02870361, 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 8 May 2018.