Type 2 DiabetesGPR120NCT03285750
Expression of G-protein Coupled Receptor 120 Receptor in Adipose Tissue of German Diabetes Center Cohort Subjects
An observational study of Type 2 Diabetes, run by German Diabetes Center at 1 site in Germany.
Trial summary
G-protein coupled receptor 120 (GPR120) is a G-protein-coupled receptor whose endogenous ligands have been identified as long-chain fatty acids. Recently, it has been shown that GPR120 expression in human adipose tissue is higher in obese than in lean individuals. Read more about this study
- Who is it for?
- Ages 20 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2013to Sep 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 20 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with recently diagnosed type 2 diabetes (up to one year from diagnosis) and age- and weight-matched normoglycemic controls
Who may be able to join
- Type 2 diabetes mellitus / normoglycemia
- BMI < 27,5 or > 30 kg/m2
- Age 20 - 69 years
Who cannot join
- severe chronic diseases
- anemia
- medication altering fatty acid metabolism
Trial locations and contacts
1 site in 1 country.
Germany1 site
German Diabetes Center
Düsseldorf, North Rhine-Westphalia, 40225
About this study
Official title: Expression of GPR120 Receptor in Adipose Tissue of Type 2 Diabetic Subjects
G-protein coupled receptor 120 (GPR120) is a G-protein-coupled receptor whose endogenous ligands have been identified as long-chain fatty acids. Recently, it has been shown that GPR120 expression in human adipose tissue is higher in obese than in lean individuals. Interestingly, a GPR120 deficient mouse model presents an unfavorable phenotype when fed a high-fat diet with obesity, glucose intolerance and fatty liver, characteristics also found in type 2 diabetes (T2D).
Moreover, in obese subjects, a single nucleotide polymorphism (R270H) has been identified that inhibits GPR120 signaling activity.
The investigators now want to investigate if GPR120 expression in adipose tissue may be altered in patients with T2D compared to non-diabetic subjects and might contribute to diabetes-associated metabolic changes. Additionally, the investigators want to assess the frequency of the R270H mutant in T2D.
- Conditions
- Type 2 Diabetes
- Keywords
- GPR120, Adipose tissue, Type 2 diabetes
- Medical subject headings
- 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 |
|---|---|---|
| Diabetic group | Patients with recently diagnosed type 2 diabetes | |
| Controls | Age- and BMI-matched normoglycemic subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
GPR120 expression in adipose tissue
GPR expression is measured in adipose tissue of recently diagnosed type 2 diabetic patients and age- and BMI-matched normoglycemic controls
Measured: Expression measured at baseline (day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2017
- Study startAug 2013
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- German Diabetes Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Roden, Prof., MD, Principal investigator, German Diabetes Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03285750
- Sponsor's protocol ID
- GPR120 study
- Acronym
- GPR120
- Status last verified
- Jun 2023
- First submitted
- 13 Aug 2013
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expression of GPR120 Receptor in Adipose Tissue of Type 2 Diabetic Subjects
- ClinicalTrials.gov ID
- NCT03285750
- Acronym / sponsor ID
- GPR120 / GPR120 study
- Conditions
- Type 2 Diabetes
- Keywords
- GPR120, Adipose tissue, Type 2 diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- German Diabetes CenterUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 18 Sep 2017 (actual)
- 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-protein coupled receptor 120 (GPR120) is a G-protein-coupled receptor whose endogenous ligands have been identified as long-chain fatty acids. Recently, it has been shown that GPR120 expression in human adipose tissue is higher in obese than in lean individuals. Interestingly, a GPR120 deficient mouse model presents an unfavorable phenotype when fed a high-fat diet with obesity, glucose intolerance and fatty liver, characteristics also found in type 2 diabetes (T2D).
Moreover, in obese subjects, a single nucleotide polymorphism (R270H) has been identified that inhibits GPR120 signaling activity.
The investigators now want to investigate if GPR120 expression in adipose tissue may be altered in patients with T2D compared to non-diabetic subjects and might contribute to diabetes-associated metabolic changes. Additionally, the investigators want to assess the frequency of the R270H mutant in T2D.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetic group | – | –Patients with recently diagnosed type 2 diabetes |
| Controls | – | –Age- and BMI-matched normoglycemic subjects |
Who may qualify
- Ages
- 20 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with recently diagnosed type 2 diabetes (up to one year from diagnosis) and age- and weight-matched normoglycemic controls
Key inclusion criteria (3 listed)
- Type 2 diabetes mellitus / normoglycemia
- BMI < 27,5 or > 30 kg/m2
- Age 20 - 69 years
Key exclusion criteria (3 listed)
- severe chronic diseases
- anemia
- medication altering fatty acid metabolism
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
GPR120 expression in adipose tissue
Time frame: Expression measured at baseline (day 1)
GPR expression is measured in adipose tissue of recently diagnosed type 2 diabetic patients and age- and BMI-matched normoglycemic controls
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
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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.
Michael Roden, Prof., MD principal investigator
German Diabetes Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes, run by German Diabetes Center at 1 site in Germany.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
GPR120 expression in adipose tissue (time frame: Expression measured at baseline (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 15 Jun 2023.