NCT03285750

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

August 13, 2013

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 18, 2017

Completed
Last Updated

June 15, 2023

Status Verified

June 1, 2023

Enrollment Period

4.1 years

First QC Date

August 13, 2013

Last Update Submit

June 13, 2023

Conditions

Keywords

GPR120Adipose tissueType 2 diabetes

Outcome Measures

Primary Outcomes (1)

  • 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

    Expression measured at baseline (day 1)

Study Arms (2)

Diabetic group

Patients with recently diagnosed type 2 diabetes

Controls

Age- and BMI-matched normoglycemic subjects

Eligibility Criteria

Age20 Years - 69 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with recently diagnosed type 2 diabetes (up to one year from diagnosis) and age- and weight-matched normoglycemic controls

You may qualify if:

  • Type 2 diabetes mellitus / normoglycemia
  • BMI \< 27,5 or \> 30 kg/m2
  • Age 20 - 69 years

You may not qualify if:

  • severe chronic diseases
  • anemia
  • medication altering fatty acid metabolism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

German Diabetes Center

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Location

Biospecimen

Retention: SAMPLES WITH DNA

SNP Genotyping of GPR120

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Michael Roden, Prof., MD

    German Diabetes Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2013

First Posted

September 18, 2017

Study Start

August 1, 2013

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

June 15, 2023

Record last verified: 2023-06

Locations