- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01847456
Influence of Brain Insulin Sensitivity on Peripheral Insulin Sensitivity
December 20, 2013 updated by: andreas fritsche, University Hospital Tuebingen
The researchers will investigate if brain insulin action influences peripheral insulin sensitivity in healthy humans.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Tuebingen, Germany, 72074
- University of Tuebingen, Internal medicine IV
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- BMI < 28 kg/m2
- normal HbA1c
- healthy volunteers
Exclusion Criteria:
- Heparin induced thrombocytopenia (HIT)
- metal implants
- cardial diseases
- anemia
- patients taking any kind of drugs
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: insulin nasal spray
160 Units of human insulin as nasal spray
|
|
Placebo Comparator: Placebo nasal spray
Nasalspray containing placebo solution
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
45 minutes to 120 minutes post nasal spray
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Autonomous nervous system activity
Time Frame: 45 to 120 minutes post spray
|
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.
|
45 to 120 minutes post spray
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2013
Primary Completion (Actual)
November 1, 2013
Study Registration Dates
First Submitted
April 28, 2013
First Submitted That Met QC Criteria
May 3, 2013
First Posted (Estimate)
May 6, 2013
Study Record Updates
Last Update Posted (Estimate)
December 23, 2013
Last Update Submitted That Met QC Criteria
December 20, 2013
Last Verified
December 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SFB 997 A01 WP7
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Insulin Sensitivity
-
Paloma Almeda-ValdésCompleted
-
Ingredion IncorporatedUnknownFocus of the Study is Insulin SensitivityUnited States
-
University of Colorado, DenverRecruitingEndothelial Dysfunction | Vascular Stiffness | Insulin Sensitivity/Resistance | TransgenderismUnited States
-
University of Texas, El PasoCompletedInsulin Sensitivity/ResistanceUnited States
-
Rigshospitalet, DenmarkUnknownInsulin Sensitivity and Lipid Metabolism
-
Maastricht University Medical CenterCompletedVascular Function | Nitrate | Brain Insulin-sensitivityNetherlands
-
University of Alabama at BirminghamNot yet recruitingCardiovascular Diseases | Obesity | Insulin Sensitivity/Resistance | Metabolic Disease | Energy Expenditure | MetabolismUnited States
-
University Hospital TuebingenCompletedInsulin SensitivityGermany
-
University of CopenhagenCompleted
-
Marjukka KolehmainenKuopio University HospitalCompleted
Clinical Trials on Placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States