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1. Can flash glucose monitoring improve glucose management for Aboriginal and Torres Strait Islander peoples with type 2 diabetes? A protocol for a randomised controlled trial

Author

Hachem, M, Hearn, T, Kelly, R, Eer, A, Moore, B, Sommerville, C, Atkinson-Briggs, S, Twigg, S, Freund, M, O'Neal, D, Story, D, Brown, A, McLean, A, Sinha, A, Furler, J, O'Brien, R, Tran Duy, A, Clarke, P, Braat, S, Koye, DN, Eades, S, Burchill, L, Ekinci, E, Hachem, M, Hearn, T, Kelly, R, Eer, A, Moore, B, Sommerville, C, Atkinson-Briggs, S, Twigg, S, Freund, M, O'Neal, D, Story, D, Brown, A, McLean, A, Sinha, A, Furler, J, O'Brien, R, Tran Duy, A, Clarke, P, Braat, S, Koye, DN, Eades, S, Burchill, L, and Ekinci, E

Abstract

BACKGROUND: Aboriginal and Torres Strait Islander peoples are disproportionately impacted by type 2 diabetes. Continuous glucose monitoring (CGM) technology (such as Abbott Freestyle Libre 2, previously referred to as Flash Glucose Monitoring) offers real-time glucose monitoring that is convenient and easy to use compared to self-monitoring of blood glucose (SMBG). However, this technology's use is neither widespread nor subsidised for Aboriginal and Torres Strait Islander peoples with type 2 diabetes. Building on existing collaborations with a national network of Aboriginal and Torres Strait Islander communities, this randomised controlled trial aims to assess the effect of CGM compared to SMBG on (i) haemoglobin A1c (HbA1c), (ii) achieving blood glucose targets, (iii) reducing hypoglycaemic episodes and (iv) cost-effective healthcare in an Aboriginal and Torres Strait Islander people health setting. METHODS: This is a non-masked, parallel-group, two-arm, individually randomised, controlled trial (ACTRN12621000753853). Aboriginal and Torres Strait Islander adults with type 2 diabetes on injectable therapy and HbA1c ≥ 7.5% (n = 350) will be randomised (1:1) to CGM or SMBG for 6 months. The primary outcome is change in HbA1c level from baseline to 6 months. Secondary outcomes include (i) CGM-derived metrics, (ii) frequency of hypoglycaemic episodes, (iii) health-related quality of life and (iv) incremental cost per quality-adjusted life year gained associated with the CGM compared to SMBG. Clinical trial sites include Aboriginal Community Controlled Organisations, Aboriginal Medical Services, primary care centres and tertiary hospitals across urban, rural, regional and remote Australia. DISCUSSION: The trial will assess the effect of CGM compared to SMBG on HbA1c for Aboriginal and Torres Strait Islander people with type 2 diabetes in Australia. This trial could have long-term benefits in improving diabetes management and providing evidence for funding of CGM in this

Published
2024

2. Can flash glucose monitoring improve glucose management for Aboriginal and Torres Strait Islander peoples with type 2 diabetes? A protocol for a randomised controlled trial (vol 25, 493, 2024)

Author

Hachem, M, Hearn, T, Kelly, R, Eer, A, Moore, B, Sommerville, C, Atkinson-Briggs, S, Twigg, S, Freund, M, O'Neal, D, Story, D, Brown, A, McLean, A, Sinha, A, Furler, J, O'Brien, R, Tran-Duy, A, Clarke, P, Braat, S, Koye, DN, Eades, S, Burchill, L, Ekinci, E, Hachem, M, Hearn, T, Kelly, R, Eer, A, Moore, B, Sommerville, C, Atkinson-Briggs, S, Twigg, S, Freund, M, O'Neal, D, Story, D, Brown, A, McLean, A, Sinha, A, Furler, J, O'Brien, R, Tran-Duy, A, Clarke, P, Braat, S, Koye, DN, Eades, S, Burchill, L, and Ekinci, E

Published
2024

4. Cardiovascular and metabolic effects of metformin in patients with type 1 diabetes (REMOVAL): a double-blind, randomised, placebo-controlled trial

Author

Nickerson, H, Lou, O, Dutta, S, Haw, J, Anderson, C, Kean, S, Thomson, E, Gillespie, L, Gibb, J, Greenlaw, N, Keech, A, Jenkins, A, March, K, Williams, S, Coady, E, Bots, M, Dreyer, J, Jan, T, Sheffy, K, Lusky, R, Peleg, S, Shore, A, Carty, D, Donnan, P, Witham, M, Adler, A, Lonn, E, Rauchhaus, P, Lindsay, R, Brouwers, M, Van-Melckebeke, J, Hamill, T, Cuthbertson, L, Murray, A, Jolly, L, Miller, E, Hair, J, Bell, A, Carmichael, S, Douglas, E, Surtees, P, Dinnett, E, Allan, J, Watson, C, McLaughlin, M, Brindley, G, Smillie, E, Motherwell, D, MacDonald, S, Ellis, P, Stuart, D, Travers, M, Brearley, S, Greig, L, Colman, P, Nankervis, A, Forulanos, S, West, D, Vaughan, S, Bjorasen, M, Donlan, J, Vrazas, J, O'Neal, D, Horsburgh, J, Pater, H, Kent, S, Twigg, S, Fulcher, G, Denner, R, Piotrowicz, A, Januszewski, A, Coy, A, Paul, T, McDonald, C, Tereschyn, S, Schmidt, N, Weingert, M, Heard, H, Burke, S, Ooi, TC, Lochnan, H, Sorisky, A, Keely, E, Malcolm, J, Maranger, J, Favreau, C, Petherick, S, Boles, K, Rossing, P, Hansen, TW, Lund, S, Hemmingsen, B, Thorogood, N, Green, K, Robinson, T, Abouglilia, K, Nayman, D, Miller, C, Warren, R, Aizawa, K, Balasubramani, M, Toth, S, Harvey, K, Birch, G, Atkin, S, Sathyapalan, T, James, A, Javed, Z, Wilding, J, Martin, B, Birch, S, Wilcox, A, Watson, N, Oliver, N, Jugnee, N, Rutter, M, Turgut, T, Shaju, A, Yau, S, Subin, S, Walker, M, Wake, D, Millward, A, Chong, P, Hibbert, M, George, J, Schaper, N, Pinxt, J, op het Roodt, J, Phillips, Sam, Murray, L, Sleigh, L, Collier, A, Sit, LE, Allan, K, Cook, J, Campbell, K, Hodge, L, Leese, G, Reekie, G, Jaap, A, Sudworth, A, White, A, McKnight, J, Steven, L, McKay, G, Llano, A, Currie, G, Lennon, E, Johnstone, J, Shields, K, Petrie, John R, Chaturvedi, Nishi, Ford, Ian, Brouwers, Martijn C G J, Greenlaw, Nicola, Tillin, Therese, Hramiak, Irene, Hughes, Alun D, Jenkins, Alicia J, Klein, Barbara E K, Klein, Ronald, Ooi, Teik C, Rossing, Peter, Stehouwer, Coen D A, Sattar, Naveed, and Colhoun, Helen M

Published
2017
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8. Metabolite-based dietary supplementation in human type 1 diabetes is associated with microbiota and immune modulation

Author

Bell, KJ, Saad, S, Tillett, BJ, McGuire, HM, Bordbar, S, Yap, YA, Nguyen, LT, Wilkins, MR, Corley, S, Brodie, S, Duong, S, Wright, CJ, Twigg, S, Groth, BFDS, Harrison, LC, Mackay, CR, Gurzov, EN, Hamilton-Williams, EE, Marino, E, Bell, KJ, Saad, S, Tillett, BJ, McGuire, HM, Bordbar, S, Yap, YA, Nguyen, LT, Wilkins, MR, Corley, S, Brodie, S, Duong, S, Wright, CJ, Twigg, S, Groth, BFDS, Harrison, LC, Mackay, CR, Gurzov, EN, Hamilton-Williams, EE, and Marino, E

Abstract

BACKGROUND: Short-chain fatty acids (SCFAs) produced by the gut microbiota have beneficial anti-inflammatory and gut homeostasis effects and prevent type 1 diabetes (T1D) in mice. Reduced SCFA production indicates a loss of beneficial bacteria, commonly associated with chronic autoimmune and inflammatory diseases, including T1D and type 2 diabetes. Here, we addressed whether a metabolite-based dietary supplement has an impact on humans with T1D. We conducted a single-arm pilot-and-feasibility trial with high-amylose maize-resistant starch modified with acetate and butyrate (HAMSAB) to assess safety, while monitoring changes in the gut microbiota in alignment with modulation of the immune system status. RESULTS: HAMSAB supplement was administered for 6 weeks with follow-up at 12 weeks in adults with long-standing T1D. Increased concentrations of SCFA acetate, propionate, and butyrate in stools and plasma were in concert with a shift in the composition and function of the gut microbiota. While glucose control and insulin requirements did not change, subjects with the highest SCFA concentrations exhibited the best glycemic control. Bifidobacterium longum, Bifidobacterium adolescentis, and vitamin B7 production correlated with lower HbA1c and basal insulin requirements. Circulating B and T cells developed a more regulatory phenotype post-intervention. CONCLUSION: Changes in gut microbiota composition, function, and immune profile following 6 weeks of HAMSAB supplementation were associated with increased SCFAs in stools and plasma. The persistence of these effects suggests that targeting dietary SCFAs may be a mechanism to alter immune profiles, promote immune tolerance, and improve glycemic control for the treatment of T1D. TRIAL REGISTRATION: ACTRN12618001391268. Registered 20 August 2018, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=375792 Video Abstract.

Published
2022

14. The association between cardiorespiratory fitness, liver fat and insulin resistance in adults with or without type 2 diabetes: a cross sectional-analysis

Author

Sabag, A, Keating, S E, Way, Kimberley L, Sultana, R N, Lanting, S M, Twigg, S M, Johnson, N A, Sabag, A, Keating, S E, Way, Kimberley L, Sultana, R N, Lanting, S M, Twigg, S M, and Johnson, N A

Abstract

Background Exercise-induced improvements in cardiorespiratory fitness (CRF) often coincide with improvements in insulin sensitivity and reductions in liver fat content. However, there are limited data concerning the relationship between CRF and liver fat content in adults with varying degrees of metabolic dysfunction. Methods The aim of this study was to examine the association between CRF, liver fat content, and insulin resistance in inactive adults with obesity and with or without type 2 diabetes (T2D), via cross-sectional analysis. CRF was determined via a graded exercise test. Liver fat content was assessed via proton magnetic resonance spectroscopy and insulin resistance was assessed via homeostatic model of insulin resistance (HOMA-IR). A partial correlation analysis, controlling for age and gender, was performed to determine the association between CRF, demographic, cardiometabolic, and anthropometric variables. Independent t tests were performed to compare cardiometabolic outcomes between participants with T2D and participants without T2D. Results Seventy-two adults (46% male) with a mean age of 49.28 ± 10.8 years, BMI of 34.69 ± 4.87 kg/m2, liver fat content of 8.37 ± 6.90%, HOMA-IR of 3.07 ± 2.33 and CRF of 21.52 ± 3.77 mL/kg/min participated in this study. CRF was inversely associated with liver fat content (r = − 0.28, p = 0.019) and HOMA-IR (r = − 0.40, p < 0.001). Participants with T2D had significantly higher liver fat content (+ 3.66%, p = 0.024) and HOMA-IR (+ 2.44, p < 0.001) than participants without T2D. Participants with T2D tended to have lower CRF than participants without T2D (− 1.5 ml/kg/min, p = 0.094). Conclusion CRF was inversely associated with liver fa

Published
2021

24. Integrated actions of transforming growth factor-[[beta].sub.1] and connective tissue growth factor in renal fibrosis

Author

Qi, W., Twigg, S., Chen, X., Polhill, T.S., Poronnik, P., Gilbert, R.E., and Pollock, C.A.

Subjects
Transforming growth factors -- Research, Transforming growth factors -- Physiological aspects, Kidney diseases -- Research, Kidney diseases -- Physiological aspects, Fibrosis -- Research, Fibrosis -- Physiological aspects, Biological sciences
Abstract

Matrix accumulation in the renal tubulointerstitium is predictive of a progressive decline in renal function. Transforming growth factor-[[beta].sub.1] (TGF-[beta].sub.1]) and, more recently, connective tissue growth factor (CTGF) are recognized to play key roles in mediating the fibrogenic response, independently of the primary renal insult. Further definition of the independent and interrelated effects of CTGF and TGF-[[beta].sub.1] is critical for the development of effective antifibrotic strategies. CTGF (20 ng/ml) induced fibronectin and collagen IV secretion in primary cultures of human proximal tubule cells (PTC) and cortical fibroblasts (CF) compared with control values (P < 0.005 in all cases). This effect was inhibited by neutralizing antibodies to either TGF-[beta]. or to the TGF-[beta] type II receptor (T[beta]RII). TGF-[[beta].sub.1] induced a greater increase in fibronectin and collagen IV secretion in both PTC (P < 0.01) and CF (P < 0.01) compared with that observed with CTGF alone. The combination of TGF-[[beta].sub.1] and CTGF was additive in their effects on both PTC and CF fibronectin and collagen IV secretion. TGF-[[beta].sub.1] (2 ng/ml) stimulated CTGF mRNA expression within 30 min, which was sustained for up to 24 h, with a consequent increase in CTGF protein (P < 0.05), whereas CTGF had no effect on TGF-[[beta].sub.1] mRNA or protein expression. TGF-[[beta].sub.1] (2 ng/ml) induced phosphorylated (p)Smad-2 within 15 min, which was sustained for up to 24 h. CTGF had a delayed effect on increasing pSmad-2 expression, which was evident at 24 h In conclusion, this study has demonstrated the key dependence of the fibrogenic actions of CTGF on TGF-[beta]. It has further uniquely demonstrated that CTGF requires TGF-[beta], signaling through the T[beta]RII in both PTCs and CFs, to exert its fibrogenic response in this in vitro model. proximal tubule cells; cortical fibroblasts: fibronectin; collagen IV; Smad-2

Published
2005

42. A de novo substitution in BCL11B leads to loss of interaction with transcriptional complexes and craniosynostosis

Author

Goos, J, Vogel, W, Mlcochova, H, Millard, C, Esfandiari, E, Selman, S, Calpena Corpas, E, Koelling, N, Carpenter, E, Swagemakers, S, van der Spek, P, Filtz, T, Schwabe, J, Iwaniec, U, Mathijssen, I, Leid, M, Twigg, S, Pathology, and Plastic and Reconstructive Surgery and Hand Surgery

Subjects
whole genome sequencing, mice, lysine, synostosis, osteogenesis, craniosynostosis, cranium, affinity, cranial suture, genetic, transcription, coronal suture, prc2 protein, transcription factor, complex
Abstract

Craniosynostosis, the premature ossification of cranial sutures, is a developmental disorder of the skull vault, occurring in approximately 1 in 2250 births. The causes are heterogeneous, with a monogenic basis identified in ~25% of patients. Using whole-genome sequencing, we identified a novel, de novo variant in BCL11B, c.7C>A, encoding an R3S substitution (p.R3S), in a male patient with coronal suture synostosis. BCL11B is a transcription factor that interacts directly with the nucleosome remodelling and deacetylation complex (NuRD) and polycomb-related complex 2 (PRC2) through the invariant proteins RBBP4 and RBBP7. The p.R3S substitution occurs within a conserved amino-terminal motif (RRKQxxP) of BCL11B and reduces interaction with both transcriptional complexes. Equilibrium binding studies and molecular dynamics simulations show that the p.R3S substitution disrupts ionic coordination between BCL11B and the RBBP4–MTA1 complex, a subassembly of the NuRD complex, and increases the conformational flexibility of Arg-4, Lys-5 and Gln-6 of BCL11B. These alterations collectively reduce the affinity of BCL11B p.R3S for the RBBP4–MTA1 complex by nearly an order of magnitude. We generated a mouse model of the BCL11B p.R3S substitution using a CRISPR-Cas9-based approach, and we report herein that these mice exhibit craniosynostosis of the coronal suture, as well as other cranial sutures. This finding provides strong evidence that the BCL11B p.R3S substitution is causally associated with craniosynostosis and confirms an important role for BCL11B in the maintenance of cranial suture patency.

Published
2019
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43. ERF‐related craniosynostosis: The phenotypic and developmental profile of a new craniosynostosis syndrome

Author

Glass, G, O’Hara, J, Canham, N, Cilliers, D, Dunaway, D, Fenwick, A, Jeelani, N, Johnson, D, Lester, T, Lord, H, Morton, J, Nishikawa, H, Noons, P, Schwiebert, K, Shipster, C, Taylor-Beadling, A, Twigg, S, Vasudevan, P, Wall, S, Wilkie, A, and Wilson, L

Subjects
Adult, Male, Adolescent, phenotype, Infant, Newborn, intracranial pressure, Infant, Syndrome, Original Articles, facial dysmorphism, Repressor Proteins, Craniosynostoses, Young Adult, craniosynostosis, ERF, Child, Preschool, Mutation, Humans, Chiari‐1 malformation, Female, Original Article, Age of Onset, Child
Abstract

Mutations in the ERF gene, coding for ETS2 repressor factor, a member of the ETS family of transcription factors cause a recently recognized syndromic form of craniosynostosis (CRS4) with facial dysmorphism, Chiari‐1 malformation, speech and language delay, and learning difficulties and/or behavioral problems. The overall prevalence of ERF mutations in patients with syndromic craniosynostosis is around 2%, and 0.7% in clinically nonsyndromic craniosynostosis. Here, we present findings from 16 unrelated probands with ERF‐related craniosynostosis, with additional data from 20 family members sharing the mutations. Most of the probands exhibited multisutural (including pan‐) synostosis but a pattern involving the sagittal and lambdoid sutures (Mercedes‐Benz pattern) predominated. Importantly the craniosynostosis was often postnatal in onset, insidious and progressive with subtle effects on head morphology resulting in a median age at presentation of 42 months among the probands and, in some instances, permanent visual impairment due to unsuspected raised intracranial pressure (ICP). Facial dysmorphism (exhibited by all of the probands and many of the affected relatives) took the form of orbital hypertelorism, mild exorbitism and malar hypoplasia resembling Crouzon syndrome but, importantly, a Class I occlusal relationship. Speech delay, poor gross and/or fine motor control, hyperactivity and poor concentration were common. Cranial vault surgery for raised ICP and/or Chiari‐1 malformation was expected when multisutural synostosis was observed. Variable expressivity and nonpenetrance among genetically affected relatives was encountered. These observations form the most complete phenotypic and developmental profile of this recently identified craniosynostosis syndrome yet described and have important implications for surgical intervention and follow‐up.

Published
2019

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