Insulin ResistanceNCT02991365
Effect of Weight Loss on Brain Insulin Sensitivity in Humans
A study testing nasal insulin in people with Insulin Resistance, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
Obesity if known to be associated with brain insulin resistance in humans. This condition has not only implication for the brain but also for whole-body energy homeostasis. Research in rodents indicates that weight loss is able to improve insulin sensitivity of the brain. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance
- What is being tested?
- nasal insulin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2016to Dec 2024
- 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 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- HbA1c <6.5%
- Age between 40 and 75 years
- No intake of antidiabetic drugs or drugs for weight reduction
- no steroid intake
- Stable medication over 10 weeks before the start of the study
Who cannot join
- Persons who wear non-removable metal parts in or on the body.
- Persons with reduced temperature sensitivity and / or increased sensitivity to heating of the body
- Cardiovascular disease can not be ruled out, e.g. manifest coronary heart disease, heart failure greater than NYHA 2, previous heart attack, stroke condition
- Persons with hearing impairment or increased sensitivity to loud noises
- People with claustrophobia
- Minors or non-consenting subjects are also excluded
Show all 11Show fewer
- Subjects with an operation less than 3 months
- Simultaneous participation in other studies
- Neurological and psychiatric disorders
- Subjects with hemoglobin Hb <11 g / dl
- Hypersensitivity to any of the substances used
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University of Tuebingen, Department of Internal Medicine IV
Tübingen, 72076
Andreas Fritsche, Prof. Dr., +49 7071 29 82714, andreas.fritsche@med.uni-tuebingen.de
Stephanie Kullmann, Prof. Dr., +49 7071 29 87703, stephanie.kullmann@med.uni-tuebingen.de
About this study
Official title: Effekt Von Gewichtsabnahme Auf Die zentralnervöse Insulinresistenz Des Menschen
Obesity if known to be associated with brain insulin resistance in humans. This condition has not only implication for the brain but also for whole-body energy homeostasis. Research in rodents indicates that weight loss is able to improve insulin sensitivity of the brain. The current project will test this hypothesis in humans. Therefore, brain insulin sensitivity will be assessed by fMRI in combination with intranasal insulin administration, using an established protocol. Furthermore, effects of daily administration of insulin nasal spray (versus placebo) over 8 weeks will be assessed as secondary (exploratory) variables.
- Conditions
- Insulin Resistance
- Being tested
- nasal 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.
nasal insulinOther
placebo sprayOther
| Study group | Role | What they receive |
|---|---|---|
| nasal insulin | Active comparator | daily administration of 160 U of human insulin as nasal spray Receives: Other: nasal insulin |
| placebo spray | Placebo comparator | daily administration of placebo solution as nasal spray Receives: Other: placebo spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
brain insulin sensitivity
fMRI measurement will be performed before and after administration of 160 U of human insulin as nasal spray. Changes in regional activity will be quantified to assess regional brain insulin sensitivity.
Measured: 30 minutes after administration of nasal insulin
Secondary outcomes (6)
Effect of daily administration of 160 U nasal insulin or placebo over 8 weeks on body weight.
Participants will receive nasal insulin or placebo in a double-blind randomized fashion. Before and after 8 weeks body weight will be recorded.
Measured: 8 weeks
Effect of daily administration of 160 U nasal insulin or placebo over 8 weeks on glucose tolerance .
Participants will receive nasal insulin or placebo in a double-blind randomized fashion. Before and after 8 weeks glucose tolerance will be assessed using a 75 g oral glucose tolerance test.
Measured: 8 weeks
Effect of daily administration of 160 U nasal insulin or placebo over 8 weeks on body composition .
Participants will receive nasal insulin or placebo in a double-blind randomized fashion. Before and after 8 weeks body composition will be addressed by whole-body MRI and liver MRS.
Measured: 8 weeks
whole-body insulin sensitivity
Insulin sensitivity will be estimated from a frequent-sampling 75 g oral glucose tolerance test using the Matsuda formula.
Measured: 2 hours
Glucose tolerance
a 75 g oral glucose tolerance test will be performed. Glucose tolerance will be defined by the American Diabetes Association criteria.
Measured: 2 hours
Cognitive function
cognitive function will be addressed by neuropsychological testing.
Measured: 1 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionSep 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andreas Fritsche, MD, Principal investigator, University of Tübingen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02991365
- Sponsor's protocol ID
- 8 weeks study
- Status last verified
- Feb 2024
- First submitted
- 1 Dec 2016
- Last updated
- 2 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effekt Von Gewichtsabnahme Auf Die zentralnervöse Insulinresistenz Des Menschen
- ClinicalTrials.gov ID
- NCT02991365
- Acronym / sponsor ID
- 8 weeks study
- Conditions
- Insulin Resistance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 13 Dec 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.
Obesity if known to be associated with brain insulin resistance in humans. This condition has not only implication for the brain but also for whole-body energy homeostasis. Research in rodents indicates that weight loss is able to improve insulin sensitivity of the brain. The current project will test this hypothesis in humans. Therefore, brain insulin sensitivity will be assessed by fMRI in combination with intranasal insulin administration, using an established protocol. Furthermore, effects of daily administration of insulin nasal spray (versus placebo) over 8 weeks will be assessed as secondary (exploratory) variables.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nasal insulin | Active comparator | Other: nasal insulindaily administration of 160 U of human insulin as nasal spray |
| placebo spray | Placebo comparator | Other: placebo spraydaily administration of placebo solution as nasal spray |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- HbA1c <6.5%
- Age between 40 and 75 years
- No intake of antidiabetic drugs or drugs for weight reduction
- no steroid intake
- Stable medication over 10 weeks before the start of the study
Key exclusion criteria (11 listed)
- Persons who wear non-removable metal parts in or on the body.
- Persons with reduced temperature sensitivity and / or increased sensitivity to heating of the body
- Cardiovascular disease can not be ruled out, e.g. manifest coronary heart disease, heart failure greater than NYHA 2, previous heart attack, stroke condition
- Persons with hearing impairment or increased sensitivity to loud noises
- People with claustrophobia
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 |
|---|---|---|
| nasal insulin | Other | nasal insulin |
| placebo spray | Other | placebo spray |
Primary outcome
brain insulin sensitivity
Time frame: 30 minutes after administration of nasal insulin
fMRI measurement will be performed before and after administration of 160 U of human insulin as nasal spray. Changes in regional activity will be quantified to assess regional brain insulin sensitivity.
6 secondary outcomes
Effect of daily administration of 160 U nasal insulin or placebo over 8 weeks on body weight.
Time frame: 8 weeks
Effect of daily administration of 160 U nasal insulin or placebo over 8 weeks on glucose tolerance .
Time frame: 8 weeks
Effect of daily administration of 160 U nasal insulin or placebo over 8 weeks on body composition .
Time frame: 8 weeks
whole-body insulin sensitivity
Time frame: 2 hours
Glucose tolerance
Time frame: 2 hours
Cognitive function
Time frame: 1 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 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.
Andreas Fritsche, MD principal investigator
University of Tübingen Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nasal insulin in people with Insulin Resistance, 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 5 inclusion and 11 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 2 Feb 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andreas Fritsche, MD (+49 7071 29 80687, andreas.fritsche@med.uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
brain insulin sensitivity (time frame: 30 minutes after administration of nasal insulin). 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 2 Feb 2024.