Insulin SensitivityNCT03929419
"Effect of Central Insulin Administration on Whole-body Insulin Sensitivity in Women"
A study testing intranasal insulin in people with Insulin Sensitivity, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
The human brain is an insulin sensitive organ. Brain insulin action modulates peripheral insulin sensitivity in young lean men. As a underlying mechanism, the investigators previously detected suppression of endogenous glucose production and stimulation of glucose disappearance to peripheral tissue in response to… Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Insulin Sensitivity
- What is being tested?
- intranasal insulin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteGermany
- Study dates
- 21 Apr 2019to 30 Apr 2021
- 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 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- female volunteer adults
- HbA1c <6.0%
- Age between 18 and 30 years
- Standard routine laboratory
- No underlying diseases
- No medication
- No hormonal contraception
- Understanding of the explanations of the study and the instructions
Who cannot join
- Persons with limited temperature perception and / or increased temperature Sensitivity to warming of the body
- Cardiovascular disease, such as manifest coronary Heart disease, heart failure greater than NYHA 2, recent myocardial infarction
- People with a hearing disorder or increased sensitivity to loud Sounds
- persons with claustrophobia
- Minors or non-consenting subjects are also excluded
- Pregnancy or breastfeeding women
Show all 13Show fewer
- Surgery less than 3 months ago
- Simultaneous participation in other interventional studies
- Acute illness or infection within the last 4 weeks
- Neurological and psychiatric disorders
- Subjects with hemoglobin Hb <12g / dl (at screening)
- Allergic diseases
- Individuals with a history of heparin-induced thrombocytopenia (HIT)
Trial locations and contacts
1 site in 1 country.
Germany1 site
University of Tuebingen, Department of Internal Medicine IV
Tübingen, 72076
About this study
The human brain is an insulin sensitive organ. Brain insulin action modulates peripheral insulin sensitivity in young lean men. As a underlying mechanism, the investigators previously detected suppression of endogenous glucose production and stimulation of glucose disappearance to peripheral tissue in response to brain insulin delivery by nasal spray. Whether this holds true in young woman is unknown, since differences in brain insulin response between sexes have been reported. The investigators will address this question by combining the delivery of insulin to the brain as nasal spray with hyperinsulinemic euglycemic clamp experiments in natural cycling women.
In the planned randomized, placebo controlled cross-over study, female participants will undergo four hyperinsulinemic euglycemic experiments with tracer dilution, two in the first phase and two in the second phase of their menstrual cycle. On one of the study days per menstrual phase, subjects will receive intranasal insulin administration, on the other placebo spray. The protocol has been successfully applied previously in men. Based on the results of this trial, the investigators calculated a required sample size of N=10 for the planned study in women.
These experiments will help to better understand the role of brain insulin action in a broader sense. The results can be the basis for larger clinical trials that address the sex-specific impact of brain insulin resistance for glucose metabolism and diabetes risk.
Read the detailed description
"Effect of central insulin administration on whole-body insulin sensitivity in women" The human brain is an insulin sensitive organ. Brain insulin action modulates peripheral insulin sensitivity in young lean men. As a underlying mechanism, the investigators previously detected suppression of endogenous glucose production and stimulation of glucose disappearance to peripheral tissue in response to brain insulin delivery by nasal spray. Whether this holds true in young woman is unknown, since differences in brain insulin response between sexes have been reported. The investigators will address this question by combining the delivery of insulin to the brain as nasal spray with hyperinsulinemic euglycemic clamp experiments in natural cycling women.
In the planned randomized, placebo controlled cross-over study, female participants will undergo four hyperinsulinemic euglycemic experiments with tracer dilution, two in the first phase and two in the second phase of their menstrual cycle. On one of the study days per menstrual phase, subjects will receive intranasal insulin administration, on the other placebo spray. The protocol has been successfully applied previously in men. Based on the results of this trial, the investigators calculated a required sample size of N=10 for the planned study in women.
These experiments will help to better understand the role of brain insulin action in a broader sense. The results can be the basis for larger clinical trials that address the sex-specific impact of brain insulin resistance for glucose metabolism and diabetes risk.
- Conditions
- Insulin Sensitivity
- Being tested
- intranasal insulin, Placebo spray
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intranasal insulinDrug
application of 160 units human insulin
Placebo sprayDrug
nasal spray containing placebo solution
| 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 spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the peripheral insulin sensitivity
Effect of nasal insulin versus placebo on peripheral insulin sensitivity assessed by euglycemic hyperinsulinemic clamp.
Measured: 60-90 minutes and 150-210 minutes during euglycemic clamp
Secondary outcomes (5)
Correlation with autonomous nervous system activity
Correlation of the change in peripheral insulin sensitivity by central insulin action with the simultaneous change of the autonomous nervous system (measured by heart rate variability).
Measured: 70-80 minutes and 190-200 minutes during euglycemic clamp
Differential effects dependent on female sexual hormones
Correlation of the change in peripheral insulin sensitivity by central insulin action dependent on the time point in menstrual cycle
Measured: 60-90 minutes and 150-210 minutes during euglycemic clamp
Effect of menstrual cycle on insulin sensitivity before spray application
Will be measured by hyperinsulinemic euglycemic clamp
Measured: 60-90minutes
Effect of menstrual cycle on brain insulin sensitivity
Brain insulin sensitivity will be assessed by functional magnetic resonance imaging combined with intranasal insulin administration during the follicular and the luteal phase of the menstrual cycle
Measured: 60-90 minutes
Effect of menstrual cycle on processing of food cues in the brain
Processing of food cues in the brain will be assessed by functional magnetic resonance imaging during the follicular and the luteal phase of the menstrual cycle
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2019
- Study start21 Apr 2019
- Primary completion25 Mar 2021
- Study completion30 Apr 2021
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
- 29 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
- NCT03929419
- Sponsor's protocol ID
- 568/2018BO1
- Status last verified
- Nov 2020
- First submitted
- 15 Apr 2019
- Last updated
- 5 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hummel J, Benkendorff C, Fritsche L, Prystupa K, Vosseler A, Gancheva S, Trenkamp S, Birkenfeld AL, Preissl H, Roden M, Haring HU, Fritsche A, Peter A, Wagner R, Kullmann S, Heni M. Brain insulin action on peripheral insulin sensitivity in women depends on menstrual cycle phase. Nat Metab. 2023 Sep;5(9):1475-1482. doi: 10.1038/s42255-023-00869-w. Epub 2023 Sep 21.
PubMed 37735274
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Effect of Central Insulin Administration on Whole-body Insulin Sensitivity in Women"
- ClinicalTrials.gov ID
- NCT03929419
- Acronym / sponsor ID
- 568/2018BO1
- Conditions
- Insulin Sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 21 Apr 2019 (actual)
- Primary completion
- 25 Mar 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 26 Apr 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 human brain is an insulin sensitive organ. Brain insulin action modulates peripheral insulin sensitivity in young lean men. As a underlying mechanism, the investigators previously detected suppression of endogenous glucose production and stimulation of glucose disappearance to peripheral tissue in response to brain insulin delivery by nasal spray. Whether this holds true in young woman is unknown, since differences in brain insulin response between sexes have been reported. The investigators will address this question by combining the delivery of insulin to the brain as nasal spray with hyperinsulinemic euglycemic clamp experiments in natural cycling women.
In the planned randomized, placebo controlled cross-over study, female participants will undergo four hyperinsulinemic euglycemic experiments with tracer dilution, two in the first phase and two in the second phase of their menstrual cycle. On one of the study days per menstrual phase, subjects will receive intranasal insulin administration, on the other placebo spray. The protocol has been successfully applied previously in men. Based on the results of this trial, the investigators calculated a required sample size of N=10 for the planned study in women.
These experiments will help to better understand the role of brain insulin action in a broader sense. The results can be the basis for larger clinical trials that address the sex-specific impact of brain insulin resistance for glucose metabolism and diabetes risk.
Detailed description
"Effect of central insulin administration on whole-body insulin sensitivity in women" The human brain is an insulin sensitive organ. Brain insulin action modulates peripheral insulin sensitivity in young lean men. As a underlying mechanism, the investigators previously detected suppression of endogenous glucose production and stimulation of glucose disappearance to peripheral tissue in response to brain insulin delivery by nasal spray. Whether this holds true in young woman is unknown, since differences in brain insulin response between sexes have been reported. The investigators will address this question by combining the delivery of insulin to the brain as nasal spray with hyperinsulinemic euglycemic clamp experiments in natural cycling women.
In the planned randomized, placebo controlled cross-over study, female participants will undergo four hyperinsulinemic euglycemic experiments with tracer dilution, two in the first phase and two in the second phase of their menstrual cycle. On one of the study days per menstrual phase, subjects will receive intranasal insulin administration, on the other placebo spray. The protocol has been successfully applied previously in men. Based on the results of this trial, the investigators calculated a required sample size of N=10 for the planned study in women.
These experiments will help to better understand the role of brain insulin action in a broader sense. The results can be the basis for larger clinical trials that address the sex-specific impact of brain insulin resistance for glucose metabolism and diabetes risk.
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 | Active comparator | Drug: intranasal insulin160 Units of human insulin as nasal spray |
| Placebo nasal spray | Placebo comparator | Drug: Placebo sprayNasal spray containing placebo solution |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- female volunteer adults
- HbA1c <6.0%
- Age between 18 and 30 years
- Standard routine laboratory
- No underlying diseases
Key exclusion criteria (13 listed)
- Persons with limited temperature perception and / or increased temperature Sensitivity to warming of the body
- Cardiovascular disease, such as manifest coronary Heart disease, heart failure greater than NYHA 2, recent myocardial infarction
- People with a hearing disorder or increased sensitivity to loud Sounds
- persons with claustrophobia
- Minors or non-consenting subjects are also excluded
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 insulinapplication of 160 units human insulin | Drug | Insulin nasal spray |
| Placebo spraynasal spray containing placebo solution | Drug | Placebo nasal spray |
Primary outcome
Change in the peripheral insulin sensitivity
Time frame: 60-90 minutes and 150-210 minutes during euglycemic clamp
Effect of nasal insulin versus placebo on peripheral insulin sensitivity assessed by euglycemic hyperinsulinemic clamp.
5 secondary outcomes
Correlation with autonomous nervous system activity
Time frame: 70-80 minutes and 190-200 minutes during euglycemic clamp
Differential effects dependent on female sexual hormones
Time frame: 60-90 minutes and 150-210 minutes during euglycemic clamp
Effect of menstrual cycle on insulin sensitivity before spray application
Time frame: 60-90minutes
Effect of menstrual cycle on brain insulin sensitivity
Time frame: 60-90 minutes
Effect of menstrual cycle on processing of food cues in the brain
Time frame: 20 minutes
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 5 Sep 2021.
- Derived from this study: PubMed 37735274Hummel J, Benkendorff C, Fritsche L, Prystupa K, Vosseler A, Gancheva S, Trenkamp S, Birkenfeld AL, Preissl H, Roden M, Haring HU, Fritsche A, Peter A, Wagner R, Kullmann S, Heni M. Brain insulin action on peripheral insulin sensitivity in women depends on menstrual cycle phase. Nat Metab. 2023 Sep;5(9):1475-1482. doi: 10.1038/s42255-023-00869-w. Epub 2023 Sep 21.
- Individual participant dataSharing planned: No
Related trials for Insulin Sensitivity
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Not yet recruitingPhase 2
Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity
Insulin Resistance, Obesity
Recruiting
Improving Sleep Health and Circadian Timing to Support Cardiometabolic Health in Adolescents
Overweight Adolescents, Sleep
Not yet recruitingObservational study
Clinical Research Trial to Study Insulin Sensitivity Using Automated Glucose Clamp Technology
Obesity Type 2 Diabetes Mellitus, Obese Adults
Not yet recruiting
Effects of Mango on Insulin Sensitivity in Prediabetes
Pre Diabetes
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 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 8 inclusion and 13 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 5 Sep 2021. 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?
Change in the peripheral insulin sensitivity (time frame: 60-90 minutes and 150-210 minutes during euglycemic 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 NCT03929419, 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 5 Sep 2021.