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It has been decided by the Sponsor not to conduct the trial.
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Association of defined G protein- and FTO-related genotypes with the T2DM risk of healthy volunteers from a blood sample. | day 1 |
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Inclusion Criteria:
General
Informed consent obtained before any trial-related activities
Males and females equal or more than 18 years old Healthy volunteer-specific
Considered generally healthy based on medical history and physical examination as per discretion of the investigator
T2DM-specific
T2DM diagnosis prior to the start of trial examinations.
T1DM-specific
T1DM diagnosed clinically prior to start of trial examinations
Exclusion Criteria:
General
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
Previous diagnosis of any type of diabetes mellitus, e.g. T1DM, T2DM, gestational diabetes, maturity onset diabetes of the young, etc.
T2DM-specific
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.
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Healthy volunteers and patients with diabetes
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| Name | Affiliation | Role |
|---|---|---|
| Leona Plum-Mörschel, MD | Profil Institut fuer Stoffwechselforschung GmbH | Principal Investigator |
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| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| D003922 | Diabetes Mellitus, Type 1 |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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whole blood samples
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |