Salivary Transcriptome Biomarkers for Early Diabetes Detection

Status Active, not recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02673762
Study type	Observational
Source	PeriRx
Contact
Status	Active, not recruiting
Phase
Start date	January 2016
Completion date	February 2019

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03142633` - MicroRNA as Biomarkers for Development of Metabolic Syndrome in Women With Polycystic Ovary Syndrome
Recruiting	`NCT04984226` - Sodium Bicarbonate and Mitochondrial Energetics in Persons With CKD	Phase 2
Recruiting	`NCT05354245` - Using a Complex Carbohydrate Mixture to Steer Fermentation and Improve Metabolism in Adults With Overweight and Prediabetes (DISTAL)	N/A
Completed	`NCT03383822` - Regulation of Endogenous Glucose Production by Brain Insulin Action in Insulin Resistance	Phase 1/Phase 2
Recruiting	`NCT06007404` - Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
Suspended	`NCT03652987` - Endocrine and Menstrual Disturbances in Women With Polycystic Ovary Syndrome (PCOS)
Completed	`NCT04203238` - Potato Research for Enhancing Metabolic Outcomes	N/A
Recruiting	`NCT03658564` - Preoperative Oral Carbohydrate Treatment Minimizes Insulin Resistance	N/A
Completed	`NCT04183257` - Effect of Escalating Oral Vitamin D Replacement on HOMA-IR in Vitamin D Deficient Type 2 Diabetics	Phase 4
Completed	`NCT04117802` - Effects of Maple Syrup on Gut Microbiota Diversity and Metabolic Syndrome	N/A
Completed	`NCT03627104` - Effect of Dietary Protein and Energy Restriction in the Improvement of Insulin Resistance in Subjects With Obesity	N/A
Completed	`NCT05124847` - TREating Pediatric Obesity	N/A
Active, not recruiting	`NCT03288025` - Pulmonary Arterial Hypertension Improvement With Nutrition and Exercise (PHINE)	N/A
Completed	`NCT03809182` - Effect of Dexmedetomidine on Postoperative Glucose and Insulin Levels.	Phase 4
Completed	`NCT01809288` - Identifying Risk for Diabetes and Heart Disease in Women
Completed	`NCT04642482` - Synbiotic Therapy on Intestinal Microbiota and Insulin Resistance in Obesity	Phase 4
Terminated	`NCT03278236` - Does Time Restricted Feeding Improve Glycaemic Control in Overweight Men?	N/A
Not yet recruiting	`NCT06159543` - The Effects of Fresh Mango Consumption on Cardiometabolic Outcomes in Free-living Individuals With Prediabetes	N/A
Not yet recruiting	`NCT05540249` - Pre-operative Carbohydrates in Diabetic Patients Undergoing CABG	N/A
Withdrawn	`NCT04741204` - Metformin Use to Reduce Disparities in Newly Diagnosed Breast Cancer	Phase 4