NCT01847456

Brief Summary

The researchers will investigate if brain insulin action influences peripheral insulin sensitivity in healthy humans.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

April 28, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 6, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Last Updated

December 23, 2013

Status Verified

December 1, 2013

Enrollment Period

7 months

First QC Date

April 28, 2013

Last Update Submit

December 20, 2013

Conditions

Insulin Sensitivity

Keywords

whole body insulin sensitivityinsulin action in the brain

Outcome Measures

Primary Outcomes (1)

  • Insulin sensitivity as measured by clamp

    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 Outcomes (1)

  • Autonomous nervous system activity

    45 to 120 minutes post spray

Study Arms (2)

insulin nasal spray

EXPERIMENTAL

160 Units of human insulin as nasal spray

Drug: human insulin as nasal spray

Placebo nasal spray

PLACEBO COMPARATOR

Nasalspray containing placebo solution

Drug: Placebo

Interventions

human insulin as nasal sprayDRUG
insulin nasal spray
PlaceboDRUG
Placebo nasal spray

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI \< 28 kg/m2
  • normal HbA1c
  • healthy volunteers

You may not qualify if:

  • Heparin induced thrombocytopenia (HIT)
  • metal implants
  • cardial diseases
  • anemia
  • patients taking any kind of drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Tuebingen, Internal medicine IV

Tübingen, 72074, Germany

Location

Related Publications (1)

  • Heni M, Wagner R, Kullmann S, Veit R, Mat Husin H, Linder K, Benkendorff C, Peter A, Stefan N, Haring HU, Preissl H, Fritsche A. Central insulin administration improves whole-body insulin sensitivity via hypothalamus and parasympathetic outputs in men. Diabetes. 2014 Dec;63(12):4083-8. doi: 10.2337/db14-0477. Epub 2014 Jul 15.

    PMID: 25028522DERIVED

MeSH Terms

Conditions

Insulin Resistance

Interventions

InsulinNasal Sprays

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

ProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsAerosolsColloidsComplex MixturesDosage FormsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

April 28, 2013

First Posted

May 6, 2013

Study Start

April 1, 2013

Primary Completion

November 1, 2013

Last Updated

December 23, 2013

Record last verified: 2013-12

Locations

DE(1)