Salivary Transcriptome Biomarkers for Early Diabetes Detection
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Endocrine, Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/17/2018 |
| Start Date: | January 2016 |
| End Date: | February 2019 |
A PRoBE design study will be used to obtain saliva from patients before undergoing blood
study evaluation for screening at risk patients for the presence of undiagnosed pre-diabetes
of type II diabetes. Pre-specified saliva biomarkers will be evaluated along with
multi-marker models for their discriminatory value for distinguishing patients with normal
glucose metabolism from those with disease. Appropriate housekeeping genes will also be
incorporated to allow for the measurement of relative gene expression.
study evaluation for screening at risk patients for the presence of undiagnosed pre-diabetes
of type II diabetes. Pre-specified saliva biomarkers will be evaluated along with
multi-marker models for their discriminatory value for distinguishing patients with normal
glucose metabolism from those with disease. Appropriate housekeeping genes will also be
incorporated to allow for the measurement of relative gene expression.
Prospective-specimen-collection, retrospective-blinded-evaluation (PRoBE) methods will be
employed to collect saliva and evaluate transcriptome markers for early pre-diabetes and type
II diabetes identification. At risk patients will have fasting blood glucose and insulin
levels measured along with hemoglobin A1c and 2 hour post-prandial glucose levels. Saliva
samples will be stored and will be analyzed after pre-specifying a panel of mRNAs and a multi
marker model for validation. The pre-specified mRNAs and multi-marker model will be
determined after analysis of data from a currently ongoing case-control study. After
analyzing the data from this prior trial a validation plan will be locked before analysis of
the prospectively collected specimens. Pre-diabetes will be defined based on abnormal glucose
tolerance tests. Insulin resistance will be calculated as HOMA IR. The diagnostic value of
the salivary transcriptome for will be compared with that of hemoglobin A1c and fasting blood
glucose for the detection of pre-diabetes, insulin resistance and type II diabetes.
employed to collect saliva and evaluate transcriptome markers for early pre-diabetes and type
II diabetes identification. At risk patients will have fasting blood glucose and insulin
levels measured along with hemoglobin A1c and 2 hour post-prandial glucose levels. Saliva
samples will be stored and will be analyzed after pre-specifying a panel of mRNAs and a multi
marker model for validation. The pre-specified mRNAs and multi-marker model will be
determined after analysis of data from a currently ongoing case-control study. After
analyzing the data from this prior trial a validation plan will be locked before analysis of
the prospectively collected specimens. Pre-diabetes will be defined based on abnormal glucose
tolerance tests. Insulin resistance will be calculated as HOMA IR. The diagnostic value of
the salivary transcriptome for will be compared with that of hemoglobin A1c and fasting blood
glucose for the detection of pre-diabetes, insulin resistance and type II diabetes.
Inclusion Criteria:
- Adult patients with unknown glucose metabolism status and
- Requiring clinically driven screening for abnormal glucose metabolism and
- Outpatient status
Exclusion Criteria:
- Patients on treatment for abnormal glucose metabolism including diet and drug therapy
- Patients with a prior diagnosis of abnormal glucose metabolism
- Patients on treatment with corticosteroids
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