Trial document





This trial has been registered retrospectively.
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  DRKS00000537

Trial Description

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Title

Classical conditioning of intranasal insulin in healthy humans

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

We know that a number of hormones can be administered via the nose (intranasal administration) and thereby induce effects within the brain. We here examine the effects of the hormone insulin in the brain. On day 1, subjects were given a smell either combined with multiple administrations of intranasal insulin (in the experimental group) or with placebo (in the control group). On day 2, all subjects were given the smell and intranasal placebo. We here assess some of the putative insulin effects in the brain – i.e. its effects on food-intake, blood glucose and selected hormones, and memory. Moreover, we assessed whether the effects obtained under insulin can be learnt via Pavlovian conditioning when the stimulus previously signalling insulin (the smell) is combined with placebo in both groups at day 2. Conditioning means that the effects we obtained after insulin remain, when we present a placebo under the same environmental conditions that were prevalent when insulin was given. The most important results are reported when the study is published.

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Brief Summary in Scientific Language


Insulin receptors are localized within the brain – with highest density in the olfactory bulbs, the hypothalamus, hippocampus, the amygdalae, and in the cerebral cortex. By intranasal administration, insulin can be transported into the central nervous system (CNS), reaching these receptors while maintaining euglycemia. Thus, the effect of insulin - unconfounded by hypoglycenia - can be examined. In the present study we compare insulin vs. placebo-treated subjects: On day 1, subjects were given a smell either combined with multiple administrations of intranasal insulin (in the experimental group) or with placebo (in the control group). On day 2, all subjects were given the smell and intranasal placebo. We examine the following questions addressing features of the CNS profile of insulin in healthy, normal-weight men. Does intranasal insulin 1. reduce food-intake and affect the interoception of hunger, 2., induce systematic effects in peripheral blood glucose, peripheral insulin, leptin, cortisol, and catecholamines within the euglycemic range, 3 affect memory performance, 4. can the insulin-induced effects be learnt by classical (Pavlovian) conditioning. If Pavlovian conditioning occurred, subjects should demonstrate insulin-like responses when receiving a placebo in the so far insulin-associated environment. Results will be inserted here after publication of the study.

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Organizational Data

  •   DRKS00000537
  •   2010/09/15
  •   [---]*
  •   yes
  •   Approved
  •   1444, Ethik-Kommission an der Medizinischen Fakultät der Heinrich-Heine-Universität Düsseldorf
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Secondary IDs

  •   4015304 
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Health Condition or Problem studied

  •   We examined only healthy subjects

    Application for prevention and treatment of adiposity might be considered
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Interventions/Observational Groups

  •   Intranasally administered insulin (6X 20 international units IU)
  •   Placebo
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Double or multiple blind
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  •   Placebo
  •   Basic research/physiological study
  •   Parallel
  •   I
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Primary Outcome


Food-intake behavior (calorie intake) as a reduction in a standardized test meal in the exreimental- compared to the control group;

Blood glucose and peripheral insulin under euglycemia: Relative to baseline: cumulative change of blood glucose (11 measurement poits) and insulin (6 measurement points) in the experimental- compared to the control group

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Secondary Outcome

Peripheral leptin, cortisol, epinephrine, norepinephrine: Cumulative change of the hormones in the experimental- compared to the control group (measurement points see insulin)


Memory: Scores in psychometric test (Lern- und Gedächtnistest LGT-3) in the experimental- compared to the control group;

EEG: acousticall-evoked potentials in the experimental group compared to the control group (1 measuremnt point baseline, 3 meaurement points during intranasal treatment)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   1999/10/07
  •   32
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Male
  •   20   Years
  •   30   Years
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Additional Inclusion Criteria

healthy male students

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Exclusion Criteria

Diabetes (also parents and siblings), allergies, chronic and/or acute rhinitis, diseases and anatomic deviations of the nose, chronic diseases: i.e., cardiovascular disorders; endocrine disorders and neurological diseases, especially seizures, chronic diseases of liver and kidneys, and other chronic diseases; medication with glucocorticoids and psychopharmacological drugs, substance abuse (alcohol, drugs); smoking; athelets were excluded

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Addresses

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    • Universität Düsseldorf, Klinik für Endokrinologie, Diabetologie und Rheumatologie
    • Mr.  Prof. Dr. med.  Werner A.  Scherbaum 
    • Moorenstr. 5
    • 40225   Düsseldorf
    • Germany
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    • Universität Osnabrück Institut für Psychologie Allgemeine Psychologie II und Biologische Psychologie
    • Ms.  Prof. Dr. rer. nat.  Ursula  Stockhorst 
    • Seminarstr. 20
    • 49074   Osnabrück
    • Germany
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    • Universität Osnabrück Institut für Psychologie Allgemeine Psychologie II und Biologische Psychologie
    • Ms.  Prof. Dr. rer. nat.  Ursula  Stockhorst 
    • Seminarstr. 20
    • 49074   Osnabrück
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft DFG
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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    •   0228-885-0
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Status

  •   Recruiting complete, follow-up complete
  •   2000/01/11
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Trial Publications, Results and other Documents

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