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An Exploratory Clinical Trial to Generate Whole Blood Samples for Analysing Genetic Polymorphisms

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02057497
Recruitment Status : Withdrawn (It has been decided by the Sponsor not to conduct the trial.)
First Posted : February 7, 2014
Last Update Posted : October 20, 2017
Sponsor:
Information provided by (Responsible Party):
Profil Institut für Stoffwechselforschung GmbH

Study Description
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Brief Summary:
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.

Condition or disease
Prediabetes Diabetes Type 1 Diabetes Type 2

Study Design
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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Other
Official 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
Actual Study Start Date : October 9, 2017
Actual Primary Completion Date : October 10, 2017
Actual Study Completion Date : October 10, 2017

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Groups and Cohorts
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Group/Cohort
Healthy volunteers
Considered generally healthy based on medical history and physical examination as per discretion of the investigator
Type 1 Diabetes
T1DM diagnosed clinically prior to start of trial examinations
Type 2 Diabetes
T2DM diagnosis prior to the start of trial examinations


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Association of defined G protein- and FTO-related genotypes with the T2DM risk of healthy volunteers from a blood sample. [ Time Frame: day 1 ]

Biospecimen Retention:   Samples With DNA
whole blood samples

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy volunteers and patients with diabetes
Criteria

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

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02057497


Sponsors and Collaborators
Profil Institut für Stoffwechselforschung GmbH
Investigators
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Principal Investigator: Leona Plum-Mörschel, MD Profil Institut fuer Stoffwechselforschung GmbH
More Information
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Responsible Party: Profil Institut für Stoffwechselforschung GmbH
ClinicalTrials.gov Identifier: NCT02057497    
Other Study ID Numbers: OBDM-02
First Posted: February 7, 2014    Key Record Dates
Last Update Posted: October 20, 2017
Last Verified: October 2017
Additional relevant MeSH terms:
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Diabetes Mellitus
Prediabetic State
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases