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UnknownNCT04018430

Impact of Oral Glucose Tolerance Test on Extent of Hemoglobin Glycation

Impact d'Une Surcharge Glycemique Sur le Taux HbA1c

Status
Unknown
Phase
Study type
Observational
Enrollment
100 (estimated)
Sponsor
Urs E. Nydegger · Industry
Sex
All
Age
5 Years – 40 Years
Healthy volunteers
Accepted

Summary

The glycation extent of human hemoglobin is under control of the Maillard reaction, a chemical interaction between an amino acide and a reducing sugar. About 5% ( 31.1 mmol/mol) of hemoglobin molecules secluded in a red blood cell are glycated; excessive values \> 6.5% point to prediabetes or overt diabetes mellitus. To ascertain the diagnosis doctors prescribe oral glucose tolerance upon which glucose concentrations in blood increase - how much HbA1c reacts under these circumstances is ill known.

Detailed description

Medical laboratory assays for delineation of impaired glucose metabolism and overt diabetes mellitus, beyond measurement of (fasting) blood serum or plasma glucose levels, include extent of hemoglobin A1c glycation, concentration of fructosamines, insulin concentrations to calculate the homeostasis model assessment (HOMA) index and other clinically putative biomarkers of glucose homoeostasis. HbA1c levels form now part of routine elucidation of metabolic disorders and are used for therapy monitoring. Initially used to monitor glucose levels in follow-up care of diabetics it is considered as a track marker of ups and downs of blood glucose concentrations. Its behavior under the 2 h period of oral glucose tolerance tests (OGTT) is ill known - most clinicians believe the glycation extent will not change. Since the dynamics of glycation is temperature dependent,non-febrile patients under OGTT likely keep their glycation extent between time zero and 120 min after glucose charge constant but this has not been investigated and with the sensitive lab assays for HbA1c now in use we postulate a significant increase in glycation. The Patient Registry includes recruited children and adults sick from diabetes, overweight or metabolic syndrome as a whole. Three medical offices will address their patients to the VidyMed lab to perform the OGTT framed by lab assays on venous blood samples

Conditions

Timeline

Start date
2019-09-01
Primary completion
2020-09-30
Completion
2021-09-30
First posted
2019-07-12
Last updated
2019-07-12

Locations

1 site across 1 country: Switzerland

Source: ClinicalTrials.gov record NCT04018430. Inclusion in this directory is not an endorsement.