Trial document




drksid header

  DRKS00010927

Trial Description

start of 1:1-Block title

Title

Cholinergic network modulation in disinhibited eating behaviour

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

IFB-FluPET/MR

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

http://www.ifb-adipositas.de/forschung/forschungsprojekte/neuro-bildgebung

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Using one of the latest imaging techniques called combined positron emission tomography (PET)/magnetic resonance imaging (MRI) we aim to illustrate brain activities linking cerebral target structures of nicotine with eating behaviour. This imaging technique enables the direct demonstration of relevant target structures, the brain nicotinic acetylcholine receptor (nAChR), as well as the quantitative assessment of their availability at the same time. We hope to gain new knowledge about the effects of nicotine (and ultimately help to explain why "smoking makes you skinny") for a potential therapy approach as a healthy alternative to smoking, or for prediction of success and / or supervision of weight-reducing treatments.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

This project aims to acquire first quantitative in-human combined PET/MRI data on central α4β2*-nAChR availability in obese and non-obese individuals by applying the highly-selective (-)-[18F]Flubatine radioligand. A prospective investigation and quantitative assessment of receptor availability as well as its association with executive functions, reward sensitivity, impulsivity, eating behaviour and neuronal activity will be conducted.

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

Do you plan to share individual participant data with other researchers?

[---]*

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

[---]*

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00010927
  •   2016/08/04
  •   [---]*
  •   yes
  •   Approved
  •   225/15-ff, Ethikkommission an der Medizinischen Fakultät der Universität Leipzig
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   E66 -  Obesity
  •   disinhibited eating behaviour
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Investigation of 40 non-smoking obese volunteers with BMI >35 kg/m2 of whom N=20 have high disinhibition and N=20 have low disinhibition regarding their eating behaviour with simultaneous PET/MRI using the highly α4β2*-selective nAChR ligand (-)-[18F]Flubatine. Study participants will be investigated twice with simultaneous PET/MRI, first under baseline conditions and then with included fMRI protocol to test food-cue reactivity (high- and low- caloric food picures).
  •   Investigation of 20 non-smoking healthy controls with BMI<25 kg/m2 and low disinhibition (well performing self-regulation with respect to overeating) regarding regarding their eating behaviour with simultaneous PET/MRI using the highly α4β2*-selective nAChR ligand (-)-[18F]Flubatine. Study participants will be investigated twice with simultaneous PET/MRI, first under baseline conditions and then with included fMRI protocol to test food-cue reactivity (high- and low- caloric food picures).
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Other
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Basic research/physiological study
  •   Crossover
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

The primary outcome of our study is the quantitatively determined availavbility of the central α4β2*-nAChR (binding potential and distribution volume ratio) in the human brain.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

MRI-(resting state; task-related fMRI data, especially markers of connectivity), behavioural (impulsivity, cognition, social development) as well as hormonal (leptin, ghrelin, insulin) Parameters and their correlation with α4β2*-nAChR binding potential and distribution volume ratio.

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2017/06/12
  •   60
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   65   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

- obese: BMI > 35 kg/m²; healthy control: BMI < 25 kg/m2
- age between 18-65 years; ♀ / ♂
- non-smoking

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

- current or past neurological or psychiatric disease, (i.e. depression and anxiety)
- neurosurgical interventions
- structural tissue lesions in the braín (e.g. stroke, trauma)
- use of anorexic medication or other interventions for weight loss in the past 6 months
- prescription medication (i.e. neurotropic drugs);
- past or present history of alcohol misuse or the use of illegal drugs (ensured by means of psychological tests and urine Screening)
- known cognitive deficits or speech impairment
- simultaneous participation in any other interventional clinical study according to the German Medicinal Products Act (MPA)
- pregnancy and breast-feeding (or other contraindications for the use of radiotracers)
- MRI contraindications such as ferro-magnetism, or claustrophobia

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum Leipzig AöR Klinik und Poliklinik für Nuklearmedizin
    • Mr.  Prof. Dr. med.  Swen  Hesse 
    • Liebigstraße 18
    • 04103  Leipzig
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Universitätsklinikum Leipzig AöR Klinik und Poliklinik für Nuklearmedizin
    • Mr.  Prof. Dr. med.  Swen  Hesse 
    • Liebigstraße 18
    • 04103  Leipzig
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Univesitätsklinikum Leipzig Klinik und Poliklinik für Nuklearmedizin
    • Ms.  Dipl. Biol.  Franziska  Zientek 
    • Liebigstraße 18
    • 04103  Leipzig
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bundesministerium für Bildung und Forschung Dienstsitz Berlin
    • Friedrichstraße 130 B
    • 10117  Berlin
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.