Human Physiology of Energy HomeostasisNCT00638209
Insulin Sensitivity of the Brain in Pathogenesis of Diabetes Mellitus Type 2
A study testing Human insulin and Saline in people with Human Physiology of Energy Homeostasis, run by University Hospital Tuebingen at 2 sites in Germany.
Trial summary
The purpose of the study is to investigate whether insulin sensitivity of the human brain correlates with insulin sensitivity of the liver. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Human Physiology of Energy Homeostasis
- What is being tested?
- Human insulin and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 2 sitesGermany
- Study dates
- Feb 2008to May 2010
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-70 Risk factor(s) for type 2 diabetes (e.g. overweight, family history of diabetes)
Who cannot join
- Type 2 diabetes pregnancy acute or chronic diseases
Trial locations and contacts
2 sites in 1 country.
Germany2 sites, 2 recruiting
- Recruiting
University Hospital Tuebingen, Internal Medicine IV
Tübingen, 72076
- Recruiting
University Hospital Tuebingen
Tübingen, 72076
Andreas Fritsche, +49 7071 29 80590, andreas.fritsche@med.uni-tuebingen.de
About this study
Official title: Insulin Sensitivity of the Brain in Pathogenesis of Diabetes Mellitus Typ 2
The purpose of the study is to investigate whether insulin sensitivity of the human brain correlates with insulin sensitivity of the liver.
- Conditions
- Human Physiology of Energy Homeostasis
- Being tested
- Human insulin, Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human insulinDrug
SalineDrug
| Study group | Role | What they receive |
|---|---|---|
| I | Active comparator | Not described Receives: Drug: Human insulin |
| P | Placebo comparator | Not described Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin effect on cortical function (spectral analysis)
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2008 (estimated)
- Study startFeb 2008
- Primary completionMay 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Physiology of Energy HomeostasisStudies 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
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Collaborators
- German Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00638209
- Sponsor's protocol ID
- MEG-KFO-2
- Other IDs
- EudraCT 2006-004734-32, KFO-114
- Status last verified
- Mar 2008
- First submitted
- 12 Mar 2008
- Last updated
- 19 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insulin Sensitivity of the Brain in Pathogenesis of Diabetes Mellitus Typ 2
- ClinicalTrials.gov ID
- NCT00638209
- Acronym / sponsor ID
- MEG-KFO-2
- Conditions
- Human Physiology of Energy Homeostasis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Collaborators
- German Research Foundation
- Study start
- Feb 2008
- Primary completion
- May 2010 (estimated)
- First posted
- 19 Mar 2008 (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 purpose of the study is to investigate whether insulin sensitivity of the human brain correlates with insulin sensitivity of the liver.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I | Active comparator | Drug: Human insulin |
| P | Placebo comparator | Drug: Saline |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 18-70 Risk factor(s) for type 2 diabetes (e.g. overweight, family history of diabetes)
Key exclusion criteria (1 listed)
- Type 2 diabetes pregnancy acute or chronic diseases
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 | Drug | I |
| Saline | Drug | P |
Primary outcome
Insulin effect on cortical function (spectral analysis)
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2008.
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Human insulin and Saline in people with Human Physiology of Energy Homeostasis, run by University Hospital Tuebingen at 2 sites 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 1 inclusion and 1 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 19 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 80590, 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?
Insulin effect on cortical function (spectral analysis) (time frame: 2 weeks). 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 19 Mar 2008.