PrediabetesNCT02057497
An Exploratory Clinical Trial to Generate Whole Blood Samples for Analysing Genetic Polymorphisms
An observational study of Prediabetes and Diabetes Type 1, run by Profil Institut für Stoffwechselforschung GmbH.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Prediabetes, Diabetes Type 1, Diabetes Type 2
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 9 Oct 2017to 10 Oct 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers and patients with diabetes
Who may be able to join
- 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
Who cannot join
- 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.
About this study
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
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.
- Conditions
- Prediabetes, Diabetes Type 1, Diabetes Type 2
- Medical subject headings
- Prediabetic State, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: day 1
Secondary outcomes (1)
Association of defined G protein- and FTO-related genotypes with the T2DM risk of healthy volunteers from a blood sample.
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2014 (estimated)
- Study start9 Oct 2017
- Primary completion10 Oct 2017
- Study completion10 Oct 2017
Why it stopped: It has been decided by the Sponsor not to conduct the trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrediabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Profil Institut für Stoffwechselforschung GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Leona Plum-Mörschel, MD, Principal investigator, Profil Institut fuer Stoffwechselforschung GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02057497
- Sponsor's protocol ID
- OBDM-02
- Status last verified
- Oct 2017
- First submitted
- 4 Feb 2014
- Last updated
- 20 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02057497
- Acronym / sponsor ID
- OBDM-02
- Conditions
- Prediabetes, Diabetes Type 1, Diabetes Type 2
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: It has been decided by the Sponsor not to conduct the trial.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Profil Institut für Stoffwechselforschung GmbHIndustry (pharma, biotech, devices)
- Study start
- 9 Oct 2017 (actual)
- Primary completion
- 10 Oct 2017 (actual)
- Study completion
- 10 Oct 2017 (actual)
- First posted
- 7 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers and patients with diabetes
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Association of defined G protein- and FTO-related genotypes with the T2DM risk of healthy volunteers from a blood sample.
Time frame: day 1
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leona Plum-Mörschel, MD principal investigator
Profil Institut fuer Stoffwechselforschung GmbH
Questions about this trial
What is this clinical trial studying?
An observational study of Prediabetes and Diabetes Type 1, run by Profil Institut für Stoffwechselforschung GmbH.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2017.