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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Diabetes Type 1; Prediabetes; Diabetes Type 2

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers and patients with diabetes

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Profil Institut für Stoffwechselforschung GmbH
• Investigators: Principal Investigator: Leona Plum-Mörschel, MD, Profil Institut fuer Stoffwechselforschung GmbH

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2017
• Primary Completion (Actual): October 10, 2017
• Study Completion (Actual): October 10, 2017

Study Registration Dates

• First Submitted: February 4, 2014
• First Submitted That Met QC Criteria: February 5, 2014
• First Posted (Estimate): February 7, 2014

Study Record Updates

• Last Update Posted (Actual): October 20, 2017
• Last Update Submitted That Met QC Criteria: October 19, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
• Other Study ID Numbers: OBDM-02