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临床试验/NCT04018430
NCT04018430Unknown不适用

Impact d'Une Surcharge Glycemique Sur le Taux HbA1c

Urs E. Nydegger1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年9月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
1
主要终点
HbA1c concentration upon oral glucose tolerance testing

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
5 Years 至 40 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

HbA1c concentration upon oral glucose tolerance testing

时间窗: 48 hours

HbA1c significantly increases upon oral glucose tolerance testing

次要结局

未报告次要终点

研究者

发起方
Urs E. Nydegger
申办方类型
Industry
责任方
Sponsor Investigator
主要研究者

Urs E. Nydegger

Head Hematology Senior Consultant

Labormedizinisches Zentrum Dr. Risch

研究点 (1)

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