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

Study Overview
=================
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.

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

Conditions
-----------------
Prediabetes, Diabetes Type 1, Diabetes Type 2

Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |