The Advantages of Using a Two-Arm Crossover Study Design to Establish Proof of Concept of Technology Interventions: The Case of a Mobile Web-Based Reporting of Glucose Readings in the Management of Gestational Diabetes Mellitus (GDM)

Author(s):  
Nilmini Wickramasinghe ◽  
Steve Goldberg
2014 ◽  
Vol 106 (1) ◽  
pp. 57-66 ◽  
Author(s):  
Lorraine L. Lipscombe ◽  
Ananya Tina Banerjee ◽  
Sarah McTavish ◽  
Geetha Mukerji ◽  
Julia Lowe ◽  
...  

Nutrients ◽  
2020 ◽  
Vol 12 (2) ◽  
pp. 475 ◽  
Author(s):  
Louise Rasmussen ◽  
Maria Lund Christensen ◽  
Charlotte Wolff Poulsen ◽  
Charlotte Rud ◽  
Alexander Sidelmann Christensen ◽  
...  

Carbohydrate is the macronutrient that has the greatest impact on blood glucose response. Limited data are available on how carbohydrate distribution throughout the day affects blood glucose in women with gestational diabetes mellitus (GDM). We aimed to assess how a high-carbohydrate morning-intake (HCM) versus a low-carbohydrate-morning-intake (LCM), affect glycemic variability and glucose control. In this randomized crossover study continuous glucose monitoring (CGM) was performed in 12 women with diet treated GDM (75 g, 2-h OGTT ≥ 8.5 mmol/L), who went through 2 × 3 days of HCM and LCM. A within-subject-analysis showed a significantly higher mean amplitude of glucose excursions (MAGE) (0.7 mmol/L, p = 0.004) and coefficient of variation (CV) (5.1%, p = 0.01) when comparing HCM with LCM, whereas a significantly lower mean glucose (MG) (−0.3 mmol/L, p = 0.002) and fasting blood glucose (FBG) were found (−0.4 mmol/L, p = 0.01) on the HCM diet compared to the LCM diet. In addition, insulin resistance, expressed as Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), decreased significantly during HCM. Results indicate that a carbohydrate distribution of 50% in the morning favors lower blood glucose and improvement in insulin sensitivity in women with GDM, but in contrary gives a higher glycemic variability.


2010 ◽  
Vol 24 (S1) ◽  
Author(s):  
Alicia Clancy ◽  
Marjorie Johnson ◽  
Andrew Watson ◽  
Terri Paul ◽  
Michelle Mottola

2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Soumyalekshmi Nair ◽  
Dominic Guanzon ◽  
Nanthini Jayabalan ◽  
Andrew Lai ◽  
Katherin Scholz-Romero ◽  
...  

Abstract Background Gestational diabetes mellitus (GDM) is a serious public health issue affecting 9–15% of all pregnancies worldwide. Recently, it has been suggested that extracellular vesicles (EVs) play a role throughout gestation, including mediating a placental response to hyperglycaemia. Here, we investigated the EV-associated miRNA profile across gestation in GDM, assessed their utility in developing accurate, multivariate classification models, and determined the signaling pathways in skeletal muscle proteome associated with the changes in the EV miRNA profile. Methods Discovery: A retrospective, case–control study design was used to identify EV-associated miRNAs that vary across pregnancy and clinical status (i.e. GDM or Normal Glucose Tolerance, NGT). EVs were isolated from maternal plasma obtained at early, mid and late gestation (n = 29) and small RNA sequencing was performed. Validation: A longitudinal study design was used to quantify expression of selected miRNAs. EV miRNAs were quantified by real-time PCR (cases = 8, control = 14, samples at three times during pregnancy) and their individual and combined classification efficiencies were evaluated. Quantitative, data-independent acquisition mass spectrometry was use to establish the protein profile in skeletal muscle biopsies from normal and GDM. Results A total of 2822 miRNAs were analyzed using a small RNA library, and a total of 563 miRNAs that significantly changed (p < 0.05) across gestation and 101 miRNAs were significantly changed between NGT and GDM. Analysis of the miRNA changes in NGT and GDM separately identified a total of 256 (NGT-group), and 302 (GDM-group) miRNAs that change across gestation. A multivariate classification model was developed, based on the quantitative expression of EV-associated miRNAs, and the accuracy to correctly assign samples was > 90%. We identified a set of proteins in skeletal muscle biopsies from women with GDM associated with JAK-STAT signaling which could be targeted by the miRNA-92a-3p within circulating EVs. Interestingly, overexpression of miRNA-92a-3p in primary skeletal muscle cells increase insulin-stimulated glucose uptake. Conclusions During early pregnancy, differently-expressed, EV-associated miRNAs may be of clinical utility in identifying presymptomatic women who will subsequently develop GDM later in gestation. We suggest that miRNA-92a-3p within EVs might be a protected mechanism to increase skeletal muscle insulin sensitivity in GDM.


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