Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00005872

Trial Description

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Title

An Exploratory Clinical Trial to Generate Whole Blood Samples for Analysing Genetic Polymorphisms Related to GPCR Dependent Signalling and the FTO Gene in Healthy Volunteers and in Patients With Diabetes

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

G (guanine nucleotide binding) proteins associating with G protein-coupled receptors (GPCR)
are key players in the pathogenesis of obesity and diabetes and are targets of
pharmacotherapeutic inter-ventions. In addition, G proteins binding to GPCRs either directly
or permissively determine the efficacy of lifestyle interventions and drugs aiming at weight
management and diabetes treatment. Polymor-phisms of the fat mass and obesity-related
protein (FTO) gene have been also well characterised and linked to energy intake, body fat
mass as well as CVD risk and the susceptibility to weight-reducing interventions.
Stratifying patients according to G protein and FTO-related genotyping may enable a more
accurate prediction of individual disease courses and responses to therapeutic interventions
in terms of safety and tolerability as well as efficacy. Although the objectives primarily
refer to the analysis of G pro-tein and FTO-related genotypes, also other genes of potential
relevance for the evolution of obesity and/ or diabetes and the response to lifestyle and
pharmacological interventions may be analysed.

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Brief Summary in Scientific Language

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

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00005872
  •   2014/09/11
  •   2014/02/04
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Secondary IDs

  •   NCT02057497  (ClinicalTrials.gov)
  •   OBDM-02  (Profil Institut für Stoffwechselforschung GmbH)
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Health Condition or Problem studied

  •   Prediabetes
  •   Diabetes Type 1
  •   Diabetes Type 2
  •   E10 -  Insulin-dependent diabetes mellitus
  •   E11 -  Non-insulin-dependent diabetes mellitus
  •   R73.0 -  Abnormal glucose tolerance test
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Interventions/Observational Groups

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Characteristics

  •   Non-interventional
  •   Observational study
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  •   N/A
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Primary Outcome

- Association of defined G protein- and FTO-related genotypes with the presence of T2DM or T1DM from a blood sample; also other genes of potential relevance for the evolution of obesity and/or diabetes.; time frame: day 1

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Secondary Outcome

- Association of defined G protein- and FTO-related genotypes with the T2DM risk of healthy volunteers from a blood sample.; time frame: day 1

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

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  •   2014/09/30
  •   300
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

General

1. Informed consent obtained before any trial-related activities

2. Males and females equal or more than 18 years old Healthy volunteer-specific

3. Considered generally healthy based on medical history and physical examination as per
discretion of the investigator

T2DM-specific

4. T2DM diagnosis prior to the start of trial examinations.

T1DM-specific

5. T1DM diagnosed clinically prior to start of trial examinations

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Exclusion Criteria

General

1. Mental incapacity or language barriers which preclude adequate understanding or
cooperation, unwillingness to participate in the trial, known or suspected not to
comply with trial directives or not to be reliable or trustworthy, or subjects who in
the opinion of their general practitioner or the Investigator should not participate
in the trial.

Healthy volunteer-specific

2. Previous diagnosis of any type of diabetes mellitus, e.g. T1DM, T2DM, gestational
diabetes, maturity onset diabetes of the young, etc.

T2DM-specific

3. T1DM, diabetes resulting from pancreatic injury, or secondary forms of diabetes,
e.g., acrome-galy or Cushing's syndrome.

T1DM-specific

4. T2DM, diabetes resulting from pancreatic injury, or secondary forms of diabetes,
e.g., acrome-galy or Cushing's syndrome.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Profil Institut für Stoffwechselforschung GmbH
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    • Profil Institut fuer Stoffwechselforschung GmbH
    • Leona Plum-Mörschel, MD 
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    • Leona Plum-Mörschel, MD 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   2
  •   2014/11/27
* This entry means the parameter is not applicable or has not been set.