NCT04018430

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 10, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 12, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

July 12, 2019

Status Verified

July 1, 2019

Enrollment Period

1.1 years

First QC Date

July 10, 2019

Last Update Submit

July 10, 2019

Conditions

Keywords

glucose, insulin, HbA1c

Outcome Measures

Primary Outcomes (1)

  • HbA1c concentration upon oral glucose tolerance testing

    HbA1c significantly increases upon oral glucose tolerance testing

    48 hours

Eligibility Criteria

Age5 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Bern

Bern, Canton of Bern, 3000, Switzerland

Location

Related 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.

    PMID: 26594954BACKGROUND
  • 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.

    PMID: 27438287BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

venous blood samples processed to yield 4 ml of blood plasma

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Urs Nydegger, MD

    Labormedizinisches Zentrum Dr. Risch

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
20 Days
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head Hematology Senior Consultant

Study Record Dates

First Submitted

July 10, 2019

First Posted

July 12, 2019

Study Start

September 1, 2019

Primary Completion

September 30, 2020

Study Completion

September 30, 2021

Last Updated

July 12, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

peer reviewed publication in an anglophone scientific journal. No IPD sharing

Locations