Impact of Oral Glucose Tolerance Test on Extent of Hemoglobin Glycation

Blood Glucose, High Clinical Trial

— HbA1c  

Official title:

Impact d'Une Surcharge Glycemique Sur le Taux HbA1c

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04018430
• Other study ID #: Lmzrisch
• Status: Not yet recruiting
• Start date: September 1, 2019
• Est. completion date: September 30, 2021

Study information

• Verified date: July 2019
• Source: Labormedizinisches Zentrum Dr. Risch
• Contact: Nathalie Gilliéron, CT
• Phone: +41(0)21 622.87.32
• Email: nathalie.gillieron[@]vidymed.ch
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 40 Years

Eligibility

Inclusion Criteria:

• apparently healthy subjects or subjects supposedly experiencing a metabolic disease (e.g. prediabetes) Subjects with asked for fasting blood glucose

Exclusion Criteria:

• current steroid use thyroid dysfunction (free-thyroxin levels < 9 or > 19 pmol/L, hsCRP > 10 mg/L hospitalized

Related Conditions & MeSH terms

• Blood Glucose, High
• Hyperglycemia
• Oral Hypoglycaemic Overdose

Locations

Country	Name	City	State
Switzerland	University of Bern	Bern	Kanton Bern

Sponsors (2)

Lead Sponsor	Collaborator
Urs E. Nydegger	Labormedizinisches Zentrum Dr. Risch

Country where clinical trial is conducted

Switzerland, 

References & Publications (2)

Medina Escobar P, Moser M, Risch L, Risch M, Nydegger UE, Stanga Z. Impaired glucose metabolism and type 2 diabetes in apparently healthy senior citizens. Swiss Med Wkly. 2015 Nov 23;145:w14209. doi: 10.4414/smw.2015.14209. eCollection 2015. — View Citation

Rabbani N, Ashour A, Thornalley PJ. Mass spectrometric determination of early and advanced glycation in biology. Glycoconj J. 2016 Aug;33(4):553-68. doi: 10.1007/s10719-016-9709-8. Epub 2016 Jul 20. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c concentration upon oral glucose tolerance testing	HbA1c significantly increases upon oral glucose tolerance testing	48 hours