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Pilot Randomized Controlled Trial of Diabetes Group Prenatal Care.
Carter, EB, Barbier, K, Hill, PK, Cahill, AG, Colditz, GA, Macones, GA, Tuuli, MG, Mazzoni, SE
American journal of perinatology. 2022;(1):45-53
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Abstract
OBJECTIVE This study aimed to determine the feasibility and effectiveness of Diabetes Group Prenatal Care to increase patient engagement in diabetes self-care activities. STUDY DESIGN A pilot randomized controlled trial was conducted at two sites. Inclusion criteria were English or Spanish speaking, type 2 or gestational diabetes, 22 to 34 weeks of gestational age at first study visit, ability to attend group care at specified times, and willingness to be randomized. Exclusion criteria included type 1 diabetes, multiple gestation, major fetal anomaly, serious medical comorbidity, and serious psychiatric illness. Women were randomized to Diabetes Group Prenatal Care or individual prenatal care. The primary outcome was completion of diabetes self-care activities, including diet, exercise, blood sugar testing, and medication adherence. Secondary outcomes included antenatal care characteristics, and maternal, neonatal, and diabetes management outcomes. Analysis followed the intention-to-treat principle. RESULTS Of 159 eligible women, 84 (53%) consented to participate in the study and were randomized to group (n = 42) or individual (n = 42) prenatal care. Demographic characteristics were similar between study arms. Completion of diabetes self-care activities was similar overall, but women in group care ate the recommended amount of fruits and vegetables on more days per week (5.1 days/week ± 2.0 standard deviation [SD] in group care vs. 3.4 days ± 2.6 SD in individual care; p < 0.01) and gained less weight per week during the study period (0.2 lbs/week [interquartile range: 0-0.7] vs. 0.5 lbs/week [interquartile range: 0.2-0.9]; p = 0.03) than women in individual care. Women with gestational diabetes randomized to group care were 3.5 times more likely to have postpartum glucose tolerance testing than those in individual care (70 vs. 21%; relative risk: 3.5; 95% confidence interval: 1.4-8.8). Other maternal, neonatal, and pregnancy outcomes were similar between study arms. CONCLUSION Diabetes group care is feasible and shows promise for decreasing gestational weight gain, improving diet, and increasing postpartum diabetes testing among women with pregnancies complicated by diabetes. KEY POINTS · Women with gestational diabetes in group care were 3.5 times more likely to return for postpartum glucose tolerance testing.. · Women with gestational diabetes in group care had less gestational weight gain during the study period.. · Diabetes Group Prenatal Care is a promising intervention to improve outcomes for women with diabetes in pregnancy..
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Effects of ipragliflozin versus metformin in combination with sitagliptin on bone and muscle in Japanese patients with type 2 diabetes mellitus: Subanalysis of a prospective, randomized, controlled study (PRIME-V study).
Koshizaka, M, Ishikawa, K, Ishibashi, R, Maezawa, Y, Sakamoto, K, Uchida, D, Nakamura, S, Yamaga, M, Yokoh, H, Kobayashi, A, et al
Journal of diabetes investigation. 2021;(2):200-206
Abstract
AIMS/INTRODUCTION Recent randomized clinical trials have suggested that sodium-glucose cotransporter 2 inhibitors might reduce cardiovascular events and heart failure, and have renal protective effects. Despite these remarkable benefits, the effects of sodium-glucose cotransporter 2 inhibitors on bone and muscle are unclear. MATERIALS AND METHODS A subanalysis of a randomized controlled study was carried out to evaluate the effects of the sodium-glucose cotransporter 2 inhibitor, ipragliflozin, versus metformin on bone and muscle in Japanese patients with type 2 diabetes mellitus (baseline body mass index ≥22 kg/m2 and hemoglobin A1c 7-10%) who were already receiving sitagliptin. These patients were randomly administered ipragliflozin 50 mg or metformin 1,000-1,500 mg daily. The effects of these medications on the bone formation marker, bone alkali phosphatase; the bone resorption marker, tartrate-resistant acid phosphatase 5b (TRACP-5b); handgrip strength; abdominal cross-sectional muscle area; and bone density of the fourth lumbar vertebra were evaluated. RESULTS After 24 weeks of treatment, the changes in bone density of the fourth lumbar vertebra, handgrip strength and abdominal cross-sectional muscle area were not significantly different between the two groups. However, TRACP-5b levels increased in patients treated with ipragliflozin compared with patients treated with metformin (median 11.94 vs -10.30%, P < 0.0001), showing that ipragliflozin can promote bone resorption. CONCLUSIONS There were no adverse effects on bone or muscle when sitagliptin was used in combination with either ipragliflozin or metformin. However, ipragliflozin combination increased the levels of TRACP-5b. A long-term study is required to further understand the effects of this TRACP-5b increase caused by ipragliflozin.
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Comparison of the Effects of a Bean-Based and a White Rice-Based Breakfast Diet on Postprandial Glucose and Insulin Levels in Chinese Patients with Type 2 Diabetes.
Xiong, Q, Li, Z, Nie, R, Meng, X, Yang, XJ
Medical science monitor : international medical journal of experimental and clinical research. 2021;:e930349
Abstract
BACKGROUND This study compared the effects of a bean-based and a white rice-based breakfast diet on postprandial glucose and insulin levels in Chinese patients with type 2 diabetes mellitus (T2DM). MATERIAL AND METHODS We recruited 63 patients with T2DM. The patients participated in the randomized 2×2 crossover trial. The bean-based diet group and white rice control group were matched for 50 g of available carbohydrate at breakfast. The patients followed the diets for 3 days. Vein blood samples were collected at 0, 30, 60, 120, and 180 min after eating. Data were analyzed using a repeated-measures analysis of variance. The results are expressed as the mean±standard error of mean (SEM) or as the median with interquartile range values. RESULTS Compared with the white rice control, postprandial glucose was significantly lower with the bean-based diet treatments at 60 min (P=0.004), 120 min (P=0.000), and 180 min (P=0.000). The insulin levels of the bean-based diet group were significantly higher at 60 min (P=0.013). The C-peptide levels of the bean-based diet group were significantly higher at 30 min (P=0.042) and 60 min (P=0.005) postprandial. The glucose area under the curve (AUC) showed a similar trend (P=0.000). There were no statistically significant differences in the AUC of insulin and C-peptide, except C-peptide AUC at 0 to 60 min (P=0.027). CONCLUSIONS Compared with a white rice-based breakfast, a bean-based diet significantly reduced postprandial glucose levels and promoted insulin secretion. These results support a dietary approach to reduce postprandial hyperglycemia.
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Fully automated closed-loop glucose control compared with standard insulin therapy in adults with type 2 diabetes requiring dialysis: an open-label, randomized crossover trial.
Boughton, CK, Tripyla, A, Hartnell, S, Daly, A, Herzig, D, Wilinska, ME, Czerlau, C, Fry, A, Bally, L, Hovorka, R
Nature medicine. 2021;(8):1471-1476
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Abstract
We evaluated the safety and efficacy of fully closed-loop insulin therapy compared with standard insulin therapy in adults with type 2 diabetes requiring dialysis. In an open-label, multinational, two-center, randomized crossover trial, 26 adults with type 2 diabetes requiring dialysis (17 men, 9 women, average age 68 ± 11 years (mean ± s.d.), diabetes duration of 20 ± 10 years) underwent two 20-day periods of unrestricted living, comparing the Cambridge fully closed-loop system using faster insulin aspart ('closed-loop') with standard insulin therapy and a masked continuous glucose monitor ('control') in random order. The primary endpoint was time in target glucose range (5.6-10.0 mmol l-1). Thirteen participants received closed-loop first and thirteen received control therapy first. The proportion of time in target glucose range (5.6-10.0 mmol l-1; primary endpoint) was 52.8 ± 12.5% with closed-loop versus 37.7 ± 20.5% with control; mean difference, 15.1 percentage points (95% CI 8.0-22.2; P < 0.001). Mean glucose was lower with closed-loop than control (10.1 ± 1.3 versus 11.6 ± 2.8 mmol l-1; P = 0.003). Time in hypoglycemia (<3.9 mmol l-1) was reduced with closed-loop versus control (median (IQR) 0.1 (0.0-0.4%) versus 0.2 (0.0-0.9%); P = 0.040). No severe hypoglycemia events occurred during the control period, whereas one severe hypoglycemic event occurred during the closed-loop period, but not during closed-loop operation. Fully closed-loop improved glucose control and reduced hypoglycemia compared with standard insulin therapy in adult outpatients with type 2 diabetes requiring dialysis. The trial registration number is NCT04025775.
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Lower nocturnal blood glucose response to a potato-based mixed evening meal compared to rice in individuals with type 2 diabetes.
Devlin, BL, Parr, EB, Radford, BE, Hawley, JA
Clinical nutrition (Edinburgh, Scotland). 2021;(4):2200-2209
Abstract
BACKGROUND & AIMS Guidelines for reducing postprandial blood glucose concentrations include avoiding high glycemic index (GI) foods, such as white potatoes. However, GI testing is often undertaken in the morning with foods consumed in isolation by non-clinical cohorts. We investigated the impact of potato preparation and consumption as part of a mixed-evening meal on postprandial and nocturnal glycemic responses, and postprandial insulin response, in individuals with Type 2 Diabetes Mellitus (T2DM). METHODS In a randomized, cross-over design, 24 males and females (age 58.3 ± 9.3 y; BMI: 31.7 ± 6.8 kg/m2) with T2DM (diet or metformin controlled) completed four experimental trials after consuming a standardized breakfast (25% daily energy intake (EI)) and lunch (35% EI). Dinner (40% EI) was consumed at 1800 h being either: 1) boiled potato (BOIL); 2) roasted potato (ROAST); 3) boiled potato cooled for 24 h (COOLED); or 4) basmati rice (CONTROL). Each meal contained 50% carbohydrate, 30% fat and 20% protein. Blood samples were collected prior to, immediately post meal and at 30-min intervals for a further 120 min. A continuous glucose monitor was worn to assess nocturnal interstitial glucose concentrations. RESULTS No differences were detected in postprandial venous glucose area under the curve (iAUC) between CONTROL and all three potato conditions. Postprandial insulin iAUC was greater following COOLED compared to CONTROL (P = 0.003; 95% CI: 18.9-111.72 miU/mL). No significant differences between CONTROL and BOIL or ROAST were detected for postprandial insulin concentrations. All potato meals resulted in lower nocturnal glucose AUC than CONTROL (P < 0.001; 95% CI 4.15-15.67 mmol/L x h). CONCLUSION Compared to an isoenergetic rice meal, boiled, roasted or boiled then cooled potato-based meals were not associated with unfavourable postprandial glucose responses or nocturnal glycemic control, and can be considered suitable for individuals with T2DM when consumed as part of a mixed-evening meal. CLINICAL TRIAL REGISTRATION Australian New Zealand Clinical Trials Registry https://www.anzctr.org.au/, ACTRN 12618000480280.
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Evaluation of miR-181b and miR-126-5p expression levels in T2DM patients compared to healthy individuals: Relationship with NF-κB gene expression.
Dehghani, M, Aghaei Zarch, SM, Vahidi Mehrjardi, MY, Nazari, M, Babakhanzadeh, E, Ghadimi, H, Zeinali, F, Talebi, M
Endocrinologia, diabetes y nutricion. 2020;(7):454-460
Abstract
BACKGROUND Type 2 diabetes mellitus (T2DM) is a progressive metabolic disorder whose prevalence is rising very fast across the world. Diagnosis of this disease in early stages (pre-diabetic stage) plays an important role in reducing mortality associated with this disorder. miRNAs, as key players in the pathogenesis of T2DM, have been investigated in several studies. Furthermore, their expression profile changes in the early stages of diabetes mellitus in body fluids such as serum, peripheral blood, and peripheral blood mononuclear cell (PBMC) have been studied. Due to their high stability and the presence of non-invasive sensitive methods for their measurement, such as real-time PCR, they can be used for early diagnosis of T2DM as a biomarker. In this experimental study, the expression levels of miR-181b, miR-126-5p, and NF-κB were measured in patients with T2DM, pre-diabetic subjects, and healthy controls in a Yazd population. MATERIAL AND METHOD Ninety asymptomatic subjects including 30 T2DM, 30 pre-diabetic, and 30 healthy subjects (diagnosis based on WHO criteria) were included in this study. Real-time PCR was used to measure the expression levels of miR-181b and miR-126-5p. Moreover, the NF-κB expression level was also measured to determine its relationship with these two microRNAs. RESULT In this study, the expression level of miR-181b and miR-126-p decreased gradually in pre-diabetic as well as T2DM subjects compared to healthy controls. Furthermore, our study showed a significant negative correlation between these two miRNAs and NF-κB for the first time. CONCLUSION These results introduce these anti-inflammatory miRNAs as powerful tools for early diagnosis of T2DM.
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Folic acid and vitamin B12 supplementation in subjects with type 2 diabetes mellitus: A multi-arm randomized controlled clinical trial.
Satapathy, S, Bandyopadhyay, D, Patro, BK, Khan, S, Naik, S
Complementary therapies in medicine. 2020;:102526
Abstract
OBJECTIVE This study was conducted to investigate and compare the effects of add-on folic acid and vitamin B12 supplementation on glycaemic control, insulin resistance and serum lipid profile in subjects with type 2 diabetes mellitus. STUDY DESIGN & INTERVENTION This study was a randomized, multi-arm, open-label clinical trial. 80 patients with type 2 diabetes and on stable oral antidiabetics were enrolled and 20 patients each were randomly allocated to one of the four groups - Group A: add-on Folic acid (5 mg/day); Group B: add-on Methylcobalamin (500 mcg/day); Group C: add-on Folic acid (5 mg/day) + Methylcobalamin (500 mcg/day) and Group D: Standard oral anti-diabetic drugs. The patients were followed up after 8 weeks. RESULTS HbA1c improved significantly in Groups B and C [median changes from baseline - 1.2 % (- 13 mmol/mol) and - 1.5 % (- 16 mmol/mol) respectively, p values 0.04 and 0.02 respectively] compared to Group D. Groups B and C also showed significant improvements in plasma insulin, insulin resistance and serum adiponectin compared to Group D. Serum homocysteine declined significantly in all three groups with add-on supplementation compared to standard treatment. No improvement in the lipid profile was noted in any of the groups. CONCLUSIONS Add-on supplementation with vitamin B12 improved glycaemic control and insulin resistance in patients with type 2 diabetes mellitus.
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Comparative Effectiveness of Glucose-Lowering Drugs for Type 2 Diabetes: A Systematic Review and Network Meta-analysis.
Tsapas, A, Avgerinos, I, Karagiannis, T, Malandris, K, Manolopoulos, A, Andreadis, P, Liakos, A, Matthews, DR, Bekiari, E
Annals of internal medicine. 2020;(4):278-286
Abstract
BACKGROUND Several pharmacologic options for type 2 diabetes are available. PURPOSE To compare benefits and harms of glucose-lowering drugs in adults with type 2 diabetes. DATA SOURCES Several databases from inception through 18 December 2019 and ClinicalTrials.gov on 10 April 2020. STUDY SELECTION English-language randomized trials that had at least 24 weeks of intervention and assessed the effects of glucose-lowering drugs on mortality, glycemic, and vascular outcomes. DATA EXTRACTION Pairs of reviewers extracted data and appraised risk of bias. DATA SYNTHESIS 453 trials assessing 21 antidiabetic interventions from 9 drug classes were included. Interventions included monotherapies (134 trials), add-on to metformin-based therapies (296 trials), and monotherapies versus add-on to metformin therapies (23 trials). There were no differences between treatments in drug-naive patients at low cardiovascular risk. Insulin regimens and specific glucagon-like peptide-1 receptor agonists (GLP-1 RAs) added to metformin-based background therapy produced the greatest reductions in hemoglobin A1c level. In patients at low cardiovascular risk receiving metformin-based background treatment (298 trials), there were no clinically meaningful differences between treatments for mortality and vascular outcomes. In patients at increased cardiovascular risk receiving metformin-based background treatment (21 trials), oral semaglutide, empagliflozin, liraglutide, extended-release exenatide, and dapagliflozin reduced all-cause mortality. Oral semaglutide, empagliflozin, and liraglutide also reduced cardiovascular death. Odds of stroke were lower with subcutaneous semaglutide and dulaglutide. Sodium-glucose cotransporter-2 (SGLT-2) inhibitors reduced heart failure hospitalization and end-stage renal disease. Subcutaneous semaglutide and canagliflozin increased diabetic retinopathy and amputation, respectively. LIMITATION Inconsistent definitions of cardiovascular risk and low-level confidence in some estimates for patients at low cardiovascular risk. CONCLUSION In diabetic patients at low cardiovascular risk, no treatment differs from placebo for vascular outcomes. In patients at increased cardiovascular risk receiving metformin-based background therapy, specific GLP-1 RAs and SGLT-2 inhibitors have a favorable effect on certain cardiovascular outcomes. PRIMARY FUNDING SOURCE European Foundation for the Study of Diabetes, supported by an unrestricted educational grant from AstraZeneca. (PROSPERO CRD42019122043).
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Regional variability in Canadian routine care of type 2 diabetes, hypercholesterolemia, and hypertension: Results from the The Cardio-Vascular and metabolic treatments in Canada: Assessment of REal-life therapeutic value (CV-CARE) registry.
Goldenberg, R, Bell, A, Cheng, W, Paron, E, Fils-Aimé, N, Burrows, M, Blavignac, J, Barakat, M
Journal of cardiology. 2020;(4):385-394
Abstract
BACKGROUND Regional differences in the profile and treatment strategies of patients with cardiometabolic diseases have been studied in several different countries. The Cardio-Vascular and metabolic treatments in Canada: Assessment of REal-life therapeutic value (CV-CARE) registry was designed to evaluate patient profiles and medical management of cardiometabolic diseases in routine clinical care settings across Canada. Primary objectives were to (1) evaluate regional variability of patient profiles with cardiometabolic disease(s) and (2) assess treatment differences of patients treated for type 2 diabetes (T2D), hypercholesterolemia (HCh), and hypertension (HTN) across Canada. METHODS CV-CARE is a multi-center, observational, prospective registry that enrolled Canadian patients treated with metformin-extended release (MetER) for T2D, colesevelam (C) for HCh, azilsartan (AZI) for mild-to-moderate essential HTN and azilsartan/chlorthalidone (AZI/CHL) for severe, essential HTN. Patient characteristics and treatments were assessed at baseline. RESULTS The registry enrolled 6960 patients, with a total of 4194 patients making up the primary analysis population [MetER (n=995); C (n=1639); AZI (n=1364); AZI/CHL (n=498)]. First-line use of MetER was more common in British Columbia (BC; 45.5%) compared to Ontario (ON; 29.8%), and Quebec (QC; 12.9%). C treatment for HCh was used as monotherapy most readily in BC (68.7%) compared with QC (59.7%) and ON (35.8%). Dual action of low-density lipoprotein cholesterol and hemoglobin A1c reduction was the predominant reason for C add-on therapy (46.8%), with highest usage seen in ON (62.9%). AZI treatment for HTN was most frequently used in BC (43.8%), and AZI/CHL was most commonly used in ON (12.0%). First-line use of AZI was more common in QC (50%) vs. ON (34.9%) and BC (24.1%). The primary reason for switching to AZI and AZI/CHL from prior treatment was lack of efficacy across provinces. CONCLUSION This is the first regional description of the CV-CARE cohort. Significant variations in both baseline profile and treatments were observed which could have an impact on long-term outcomes.
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Greater macrovascular and microvascular morbidity from type 2 diabetes in northern compared with southern China: A cross-sectional study.
Wang, L, Xing, Y, Yu, X, Ming, J, Liu, X, Li, X, Fu, J, Zhou, J, Gao, B, Hu, D, et al
Journal of diabetes investigation. 2020;(5):1285-1294
Abstract
AIMS/INTRODUCTION There are substantial differences in genes, diet, culture and environment between the northern and southern Chinese populations, which might influence treatment strategy and screening policy. We studied the differences in type 2 diabetes and diabetic complications between northern and southern China. MATERIALS AND METHODS We carried out a cross-sectional survey using data from the China Cardiometabolic Registries on blood pressure, blood lipids and blood glucose in 25,398 Chinese type 2 diabetes patients. Macrovascular, microvascular and other complications were collected by self-report or medical records, and then divided into the northern and southern groups by the boundary of the Yangtze River. RESULTS Northern patients were younger, and had heavier weight, greater body mass index and waist circumference, higher blood pressure, higher total cholesterol, higher low-density lipoprotein cholesterol, and higher hemoglobin A1C. The prevalence of cardiovascular, cerebrovascular and macrovascular complications were 1.76-fold, 1.24-fold and 1.47-fold more in northern than that in southern Chinese patients. In addition, the prevalence of diabetic nephropathy, retinopathy, neuropathy and microvascular complications in northern Chinese patients also increased. When stratified by age, the difference in both cardiovascular disease and ischemic stroke morbidity became significant, even in the 35-44 years age group. CONCLUSIONS More macrovascular and microvascular complications were found in northern compared with southern patients, and the largest difference also appeared in the younger age groups <55 years, which might be meaningful to a screening and treatment strategy according to geographic differences.