An Exploratory Clinical Trial to Generate Whole Blood Samples for Analysing Genetic Polymorphisms
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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Withdrawn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
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Condition or disease |
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Prediabetes Diabetes Type 1 Diabetes Type 2 |
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 |

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

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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 |
Inclusion Criteria:
General
- Informed consent obtained before any trial-related activities
- Males and females equal or more than 18 years old Healthy volunteer-specific
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Considered generally healthy based on medical history and physical examination as per discretion of the investigator
T2DM-specific
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T2DM diagnosis prior to the start of trial examinations.
T1DM-specific
- T1DM diagnosed clinically prior to start of trial examinations
Exclusion Criteria:
General
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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
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Previous diagnosis of any type of diabetes mellitus, e.g. T1DM, T2DM, gestational diabetes, maturity onset diabetes of the young, etc.
T2DM-specific
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T1DM, diabetes resulting from pancreatic injury, or secondary forms of diabetes, e.g., acrome-galy or Cushing's syndrome.
T1DM-specific
- T2DM, diabetes resulting from pancreatic injury, or secondary forms of diabetes, e.g., acrome-galy or Cushing's syndrome.

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
Principal Investigator: | Leona Plum-Mörschel, MD | Profil Institut fuer Stoffwechselforschung GmbH |
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 |
Diabetes Mellitus Diabetes Mellitus, Type 2 Diabetes Mellitus, Type 1 Glucose Metabolism Disorders |
Metabolic Diseases Endocrine System Diseases Autoimmune Diseases Immune System Diseases |