Theresa Kössler1,2,3, Pavel Bobrov3,4, Klaus Strassburger3,4, Oliver Kuss3,4, Oana-Patricia Zaharia1,2,3, Yanislava Karusheva2,3, Clara Möser2,3, Kálmán Bódis1,2,3, Volker Burkart2,3, Michael Roden1,2,3, Julia Szendroedi5,6,7,8. 1. Division of Endocrinology and Diabetology, Medical Faculty, Heinrich Heine University, Moorenstr. 5, 40225, Düsseldorf, Germany. 2. Institute for Clinical Diabetology, German Diabetes Center, Leibniz Center for Diabetes Research At Heinrich Heine University Düsseldorf, Düsseldorf, Germany. 3. German Center for Diabetes Research (DZD), München-Neuherberg, Germany. 4. Institute for Biometrics and Epidemiology, German Diabetes Center, Leibniz Center for Diabetes Research at Heinrich Heine University Düsseldorf, Düsseldorf, Germany. 5. Division of Endocrinology and Diabetology, Medical Faculty, Heinrich Heine University, Moorenstr. 5, 40225, Düsseldorf, Germany. julia.szendroedi@ddz.de. 6. Institute for Clinical Diabetology, German Diabetes Center, Leibniz Center for Diabetes Research At Heinrich Heine University Düsseldorf, Düsseldorf, Germany. julia.szendroedi@ddz.de. 7. German Center for Diabetes Research (DZD), München-Neuherberg, Germany. julia.szendroedi@ddz.de. 8. Department of Internal Medicine I and Clinical Chemistry, University Hospital Heidelberg, Heidelberg, Germany. julia.szendroedi@ddz.de.
Abstract
BACKGROUND: Application of mixed meal tolerance tests (MMTT) to measure beta-cell function in long-term studies is limited by modification of the commercial products occurring over time. This study assessed the intra-individual reliability of MMTTs and compared the effects of liquid meals differing in macronutrient composition on the estimation of beta-cell function in type 2 diabetes (T2DM). METHODS: To test the reliability of MMTTs, 10 people with T2DM (age 58 ± 11 years, body mass index 30.0 ± 4.9 kg/m2) received Boost® high Protein 20 g protein three times. For comparing different meals, another 10 persons with T2DM (58 ± 5 years, 31.9 ± 5.3 kg/m2) ingested either Boost® high Protein 20 g protein or the isocaloric Boost® high Protein 15 g protein containing 35% less protein and 18% more carbohydrates. C-peptide, insulin and glucose release were assessed from the incremental area under the concentration time curve (iAUC) and the intra- and inter-individual variation of these parameters from the coefficients of variations (CV). RESULTS: Repetitive ingestion of one meal revealed intra-individual CVs for the iAUCs of C-peptide, insulin and glucose, which were at least 3-times lower than the inter-individual variation of these parameters (18.2%, 19.7% and 18.9% vs. 74.2%, 70.5% and 207.7%) indicating a good reliability. Ingestion of two different meals resulted in comparable intra-individual CVs of the iAUCs of C-peptide and insulin (16.9%, 20.5%). CONCLUSION: MMTTs provide reliable estimation of beta-cell function in people with T2DM. Furthermore, moderate differences in the protein and carbohydrate contents in a standardized liquid meal do not result in relevant changes of C-peptide and insulin responses. TRIAL REGISTRATION: Clinicaltrials.gov, Identifier number: NCT01055093. Registered 22 January 2010 - Retrospectively registered, https://www.clinicaltrials.gov/ct2/show/study/NCT01055093.
BACKGROUND: Application of mixed meal tolerance tests (MMTT) to measure beta-cell function in long-term studies is limited by modification of the commercial products occurring over time. This study assessed the intra-individual reliability of MMTTs and compared the effects of liquid meals differing in macronutrient composition on the estimation of beta-cell function in type 2 diabetes (T2DM). METHODS: To test the reliability of MMTTs, 10 people with T2DM (age 58 ± 11 years, body mass index 30.0 ± 4.9 kg/m2) received Boost® high Protein 20 g protein three times. For comparing different meals, another 10 persons with T2DM (58 ± 5 years, 31.9 ± 5.3 kg/m2) ingested either Boost® high Protein 20 g protein or the isocaloric Boost® high Protein 15 g protein containing 35% less protein and 18% more carbohydrates. C-peptide, insulin and glucose release were assessed from the incremental area under the concentration time curve (iAUC) and the intra- and inter-individual variation of these parameters from the coefficients of variations (CV). RESULTS: Repetitive ingestion of one meal revealed intra-individual CVs for the iAUCs of C-peptide, insulin and glucose, which were at least 3-times lower than the inter-individual variation of these parameters (18.2%, 19.7% and 18.9% vs. 74.2%, 70.5% and 207.7%) indicating a good reliability. Ingestion of two different meals resulted in comparable intra-individual CVs of the iAUCs of C-peptide and insulin (16.9%, 20.5%). CONCLUSION: MMTTs provide reliable estimation of beta-cell function in people with T2DM. Furthermore, moderate differences in the protein and carbohydrate contents in a standardized liquid meal do not result in relevant changes of C-peptide and insulin responses. TRIAL REGISTRATION: Clinicaltrials.gov, Identifier number: NCT01055093. Registered 22 January 2010 - Retrospectively registered, https://www.clinicaltrials.gov/ct2/show/study/NCT01055093.
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