The Oral Glucose Tolerance Test: Changed Results Using Different Drinking Solutions?

Abstract

Introduction

The impact of different drinking solutions used for an oral glucose tolerance test (oGTT) on 2-h glucose values and gastrointestinal side effects are not clear. This study compared a commercially produced solution (Accu-Chek Roche solution) and a standardized pharmacy solution (NRF 13.8. oGTT solution) within the German National Cohort (NAKO), including the assessment of gastrointestinal symptoms.

Methods

The Accu-Chek Roche solution comprises mono- and oligosaccharides with blackcurrant juice for enhanced flavor. The NRF 13.8. oGTT solution contained glucose monohydrates only, with citric acid to maintain the pH for preservation, and did not include flavor enhancers. Within a subgroup of the NAKO participants obtaining a standardized 75g oGTT, 818 participants each received the Accu-Chek Roche solution and the NRF 13.8. oGTT solution matched by study center, sex, age, body mass index, and fasting glucose values. Intra-class correlations for 2-h glucose values were calculated and agreement evaluated with Bland-Altman plots; additionally, coefficients of variation and their difference were estimated for the two solutions.

Results

The mean difference of the 2-h glucose concentrations between the Accu-Chek Roche and NRF 13.8. oGTT solution was − 3.4 [95% CI − 6.1; − 0.9] mg/dL. The Bland-Altman plot showed increasing variability of differences with increasing 2-h glucose concentrations without a systematic pattern. The intra-class correlations of 2-h glucose values within matched pairs were 22% [95%CI: 16%; 29%]. The coefficients of variation for 2-h glucose observed with the Accu-Chek Roche and NRF 13.8. oGTT solutions were 25% [24%; 27%] and 25% [23%; 26%], respectively, with a difference of 1% [− 1%; 3%]. Nausea or vomiting were observed in<0.1% of matched participants with no differences between the solutions.

Conclusion

The differences in 2-h glucose values and frequency of acute gastrointestinal side effects were not clinically different in participants following the consumption of the Accu-Chek Roche or the NRF 13.8. oGTT solutions.

Keywords

diabetes diagnosis - glucose - hemoglobin A1c - diagnostics - epidemiology

• References

• 1 Bergman M, Abdul-Ghani M, DeFronzo RA. et al. Review of methods for detecting glycemic disorders. Diabetes Res Clin Pract 2020; 165: 108233
• 2 World Health Organization and International Diabetes Federation. Definition and diagnosis of diabetes mellitus and intermediate hyperglycaemia. Report of a WHO/IDF Consultation Geneva. 2006 Available at https://www.who.int/publications/i/item/definition-and-diagnosis-of-diabetes-mellitus-and-intermediate-hyperglycaemia Accessed: 12.08.2023
• 3 ElSayed NA, Aleppo G, Aroda VR. et al. 2. Classification and diagnosis of diabetes: Standards of care in diabetes-2023. Diabetes Care 2023; 46: S19-S40
• 4 American Diabetes Association. 2. Classification and diagnosis of diabetes: Standards of medical care in diabetes-2021. Diabetes Care 2021; 44: S15-S33
• 5 Nielsen ML, Pareek M, Leosdottir M. et al. Follow-up duration influences the relative importance of OGTT and optimal timing of glucose measurements for predicting future type 2 diabetes. Eur J Endocrinol 2016; 174: 591-600
• 6 NCD Risk Factor Collaboration. Effects of diabetes definition on global surveillance of diabetes prevalence and diagnosis: A pooled analysis of 96 population-based studies with 331,288 participants. Lancet Diabetes Endocrinol 2015; 3: 624-637
• 7 Brohall G, Behre CJ, Hulthe J. et al. Prevalence of diabetes and impaired glucose tolerance in 64-year-old Swedish women: Experiences of using repeated oral glucose tolerance tests. Diabetes Care 2006; 29: 363-367
• 8 Meijnikman AS, De Block CEM, Dirinck E. et al. Not performing an OGTT results in significant underdiagnosis of (pre)diabetes in a high risk adult Caucasian population. Int J Obes 2017; 41: 1615-1620
• 9 Selvin E, Steffes MW, Gregg E. et al. Performance of A1C for the classification and prediction of diabetes. Diabetes Care 2011; 34: 84-89
• 10 Libman IM, Barinas-Mitchell E, Bartucci A. et al. Reproducibility of the oral glucose tolerance test in overweight children. J Clin Endocrinol Metab 2008; 93: 4231-4237
• 11 Heinemann L. Are all glucose solutions used for oGTT equal?. Diabet Med 2022; 39: e14798
• 12 Selvin E, Crainiceanu CM, Brancati FL. et al. Short-term variability in measures of glycemia and implications for the classification of diabetes. Arch Intern Med 2007; 167: 1545-1551
• 13 Heinemann L, Adamczewski H, Neumann C. et al. Gemeinsames positionspapier der Kommission Labordiagnostik in der Diabetologie der DDG und DGKL (KLD) und der Kommission Apotheker in der Diabetologie BAK/DDG zur Herstellung einer oGTT-lösung für die diagnose eines diabetes einschließlich eines Gestations diabetes. Deutsche Diabetes Gesellschaft. 2020
• 14 Heinemann L, Adamczewski H, Neumann C. et al. Addendum zum Gemeinsamen Positionspapier der Kommission Labordiagnostik in der Diabetologie der DDG und DGKL (KLD) und der Kommission Apotheker in der Diabetologie (BAK/DDG) zur Herstellung einer oGTT-Lösung für die Diagnose eines Diabetes einschließlich eines Gestationsdiabetes: Analyse und Vorschläge zur Herstellung. Diabetologie und Stoffwechsel. 2020 15. 472-476
• 15 Deutsche Diabetes Gesellschaft, Stellungnahmen. Positionspapier zur Herstellung einer oGTT-lösung für die Diagnose eines Diabetes einschließlich eines Gestationsdiabetes. Analyse und Vorschläge zur Herstellung . 2020 Available at https://www.ddg.info/politik/stellungnahmen/addendum-zum-gemeinsamen-positionspapier-zur-herstellung-einer-ogtt-loesung-fuer-die-diagnose-eines-diabetes-einschliesslich-eines-gestationsdiabetes-analyse-und-vorschlaege-zur-herstellung. Accessed: 03.03.2021
• 16 Rezeptur-Formularium (DAC/NRF). DA-CN. Glucose-Lösung 250 mg/mL für oGTT (NRF 13.8.). 2021. Available at https://www.ddg.info/fileadmin/user_upload/06_Gesundheitspolitik/01_Stellungnahmen/2020/20201028_NRF-13_8.-Glucose-Loesung-250-mg_mL-fuer-oGTT.pdf Accessed: 03.03.2021
• 17 German National Cohort (GNC) Consortium. The German National Cohort: Aims, study design and organization. Eur J Epidemiol 2014; 29: 371-382
• 18 Peters A, German National Cohort (NAKO) Consortium. Peters A. et al. Framework and baseline examination of the German National Cohort (NAKO). Eur J Epidemiol 2022; 37: 1107-1124
• 19 Schipf S, Schöne G, Schmidt B. et al. The baseline assessment of the German National Cohort (NAKO Gesundheitsstudie): Participation in the examination modules, quality assurance, and the use of secondary data. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz 2020; 63: 254-266
• 20 German Diabetes Society. Deutscher Arzneimittel-Codex Neues Rezeptur-Formularium (DAC/NRF) – Glucose-Lösung 250 mg/mL für oGTT (NRF 13.8.). DDG Stellungnahmen 2020
• 21 Fischer MM, Hannemann A, Winter T. et al. Relative efficacy of different strategies for inhibition of in vitro glycolysis. Clin Chem 2021; 67: 1032-1034
• 22 Winter T, Hannemann A, Suchsland J. et al. Long-term stability of glucose: Glycolysis inhibitor vs. gel barrier tubes. Clin Chem Lab Med 2018; 56: 1251-1258
• 23 Bundesärztekammer. Richtlinie der Bundesärztekammer zur qualitätssicherung laboratoriumsmedizinischer Untersuchungen. Deutsches Ärzteblatt 2023; 120: 1-32
• 24 Bergstralh EJ, Kosanke JL, Jacobsen SJ. Software for optimal matching in observational studies. Epidemiology 1996; 7: 331-332
• 25 Shen EX, Moses RG, Oats JJN. et al. Seasonality, temperature and pregnancy oral glucose tolerance test results in Australia. BMC Pregnancy Childbirth 2019; 19: 263
• 26 Gomez-Huelgas R, Santamaria-Fernandez S, Guijarro-Merino R. et al. Seasonal variability of glycated hemoglobin in a diabetic population from southern Europe. J Diabetes Complications 2013; 27: 618-620
• 27 Katsarou A, Claesson R, Ignell C. et al. Seasonal pattern in the diagnosis of gestational diabetes mellitus in Southern Sweden. J Diabetes Res 2016; 2016: 8905474
• 28 Menke A, Rust KF, Cowie CC. Diabetes based on 2-h plasma glucose among those classified as having prediabetes based on fasting plasma glucose or A1c. Diab Vasc Dis Res 2018; 15: 46-54
• 29 Cowie CC, Rust KF, Ford ES. et al. Full accounting of diabetes and pre-diabetes in the U.S. population in 1988-1994 and 2005-2006. Diabetes Care 2009; 32: 287-294
• 30 Rathmann W, Haastert B, Icks A. et al. High prevalence of undiagnosed diabetes mellitus in Southern Germany: Target populations for efficient screening. The KORA survey 2000. Diabetologia 2003; 46: 182-189