Impact of Oral Glucose Tolerance Test on Extent of Hemoglobin Glycation

NCT ID: NCT04018430

Last Updated: 2019-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-01

Study Completion Date

2021-09-30

Brief Summary

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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

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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

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Blood Glucose, High Oral Hypoglycaemic Overdose

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Labormedizinisches Zentrum Dr. Risch

INDUSTRY

Sponsor Role collaborator

Urs E. Nydegger

INDUSTRY

Sponsor Role lead

Responsible Party

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Urs E. Nydegger

Head Hematology Senior Consultant

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Urs Nydegger, MD

Role: STUDY_CHAIR

Labormedizinisches Zentrum Dr. Risch

Locations

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University of Bern

Bern, Canton of Bern, Switzerland

Site Status

Countries

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Switzerland

Central Contacts

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Nathalie Gilliéron, CT

Role: CONTACT

+41(0)21 622.87.32

Urs Nydegger, MD

Role: CONTACT

+41(0)58 523.34.66

References

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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.

Reference Type BACKGROUND
PMID: 26594954 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27438287 (View on PubMed)

Other Identifiers

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Lmzrisch

Identifier Type: -

Identifier Source: org_study_id

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