Impact of Oral Glucose Tolerance Test on Extent of Hemoglobin Glycation

Impact d'Une Surcharge Glycemique Sur le Taux HbA1c

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04018430

Acronym

HbA1c

Enrollment

100

Registered

2019-07-12

Start date

2019-09-01

Completion date

2021-09-30

Last updated

2019-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Glucose, High, Oral Hypoglycaemic Overdose

Keywords

glucose, insulin, HbA1c

Brief 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

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

5 Years to 40 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
HbA1c concentration upon oral glucose tolerance testing	48 hours	HbA1c significantly increases upon oral glucose tolerance testing

Countries

Switzerland

Contacts

Primary ContactNathalie Gilliéron, CT

nathalie.gillieron@vidymed.ch+41(0)21 622.87.32

Backup ContactUrs Nydegger, MD

urs.nydegger@risch.ch+41(0)58 523.34.66

Outcome results