Blood Glucose, HighHbA1cNCT04018430
Impact of Oral Glucose Tolerance Test on Extent of Hemoglobin Glycation
An observational study of Blood Glucose, High and Oral Hypoglycaemic Overdose, run by Urs E. Nydegger at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 5 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Glucose, High, Oral Hypoglycaemic Overdose
- How many people
- 100 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Sep 2019to 30 Sep 2021
- How long will I take part?
- 20 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: (i) Those suspected to suffer from the metabolic syndrome including high blood pressure, high blood sugar, excess of body fat and increased cholesterol levels (ii) patients with overt impaired carbohydrate metabolisms, under treatment and tested for follow up
Who may be able to join
- apparently healthy subjects or subjects supposedly experiencing a metabolic disease (e.g. prediabetes) Subjects with asked for fasting blood glucose
Who cannot join
- current steroid use thyroid dysfunction (free-thyroxin levels < 9 or > 19 pmol/L, hsCRP > 10 mg/L hospitalized
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact d'Une Surcharge Glycemique Sur le Taux HbA1c
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.
Read the 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
- Blood Glucose, High, Oral Hypoglycaemic Overdose
- Keywords
- glucose, insulin, HbA1c
- Medical subject headings
- Insulin Resistance
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c concentration upon oral glucose tolerance testing
HbA1c significantly increases upon oral glucose tolerance testing
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2019
- Study start1 Sep 2019 (estimated)
- Primary completion30 Sep 2020 (estimated)
- Study completion30 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Blood Glucose, HighStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 20 Days
Sponsor and investigators
- Lead sponsor
- Urs E. Nydegger
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Labormedizinisches Zentrum Dr. Risch
- Responsible party
- Sponsor-investigator, Urs E. Nydegger, Labormedizinisches Zentrum Dr. Risch
- Investigators
- Urs Nydegger, MD, Study chair, Labormedizinisches Zentrum Dr. Risch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04018430
- Sponsor's protocol ID
- Lmzrisch
- Acronym
- HbA1c
- Status last verified
- Jul 2019
- First submitted
- 10 Jul 2019
- Last updated
- 12 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: peer reviewed publication in an anglophone scientific journal. No IPD sharing
Publications
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.
PubMed 26594954Rabbani 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.
PubMed 27438287
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact d'Une Surcharge Glycemique Sur le Taux HbA1c
- ClinicalTrials.gov ID
- NCT04018430
- Acronym / sponsor ID
- HbA1c / Lmzrisch
- Conditions
- Blood Glucose, High, Oral Hypoglycaemic Overdose
- Keywords
- glucose, insulin, HbA1c
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Urs E. NydeggerIndustry (pharma, biotech, devices)
- Collaborators
- Labormedizinisches Zentrum Dr. Risch
- Study start
- 1 Sep 2019 (estimated)
- Primary completion
- 30 Sep 2020 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 12 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 20 Days
Who may qualify
- Ages
- 5 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- (i) Those suspected to suffer from the metabolic syndrome including high blood pressure, high blood sugar, excess of body fat and increased cholesterol levels (ii) patients with overt impaired carbohydrate metabolisms, under treatment and tested for follow up
Key inclusion criteria (1 listed)
- apparently healthy subjects or subjects supposedly experiencing a metabolic disease (e.g. prediabetes) Subjects with asked for fasting blood glucose
Key exclusion criteria (1 listed)
- current steroid use thyroid dysfunction (free-thyroxin levels < 9 or > 19 pmol/L, hsCRP > 10 mg/L hospitalized
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
HbA1c concentration upon oral glucose tolerance testing
Time frame: 48 hours
HbA1c significantly increases upon oral glucose tolerance testing
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2019.
- Background: PubMed 26594954Medina 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.
- Background: PubMed 27438287Rabbani 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.
- Individual participant dataSharing planned: No. peer reviewed publication in an anglophone scientific journal. No IPD sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Urs Nydegger, MD study chair
Labormedizinisches Zentrum Dr. Risch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Glucose, High and Oral Hypoglycaemic Overdose, run by Urs E. Nydegger at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nathalie Gilliéron, CT (+41(0)21 622.87.32, nathalie.gillieron@vidymed.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c concentration upon oral glucose tolerance testing (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04018430, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2019.