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Performance evaluation of a self-administered home oral glucose tolerance test kit in a controlled clinical research setting.
Dunseath, GJ, Bright, D, Jones, C, Dowrick, S, Cheung, WY, Luzio, SD
Diabetic medicine : a journal of the British Diabetic Association. 2019;(7):862-867
Abstract
AIM: To evaluate the performance of the current, pre-production version of a novel home oral glucose tolerance test (Home OGTT) device when administered by trained research nurses, compared with a reference laboratory glucose analyser and a second laboratory analyser, incorporating a sample processing delay to simulate normal practice. METHODS One hundred women (aged 19-48 years), with and without known glucose intolerance were recruited. Following an overnight fast, participants attended for a 75-g OGTT. A fasting capillary sample was applied to the Home OGTT device with a corresponding venous sample collected and measured immediately on the reference YSI 2300 stat plus analyser, and following a 1-h delay on the Randox Daytona Plus analyser. The sampling process was repeated 2 h after the oral glucose load. RESULTS Some 97% of tested devices gave complete data for analysis. Good agreement was observed between the reference glucose analyser and the Home OGTT device, with the Home OGTT device displaying a small negative bias (-0.18 mmol/l, -1.75 to 1.39 mmol/mol; -1.0%, -26.4% to 24.5%; absolute and relative mean, 95% limits of agreement). When classified as normal glucose tolerant or glucose intolerant, the Home OGTT device showed 100% and 90% sensitivity, and 99% and 99% specificity using fasting plasma glucose and 2-h glucose respectively. Similar sensitivity (100% and 100%) and specificity (96% and 99%) for fasting plasma glucose and 2-h glucose were observed using the secondary analyser. CONCLUSIONS The novel Home OGTT device was reliable and easy to use and showed excellent agreement with two separate laboratory analysers. The Home OGTT offers potential as an effective alternative for clinic-based OGTT testing.
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Diagnosis of disorders of glucose tolerance in women with polycystic ovary syndrome (PCOS) at a tertiary care center: fasting plasma glucose or oral glucose tolerance test?
Ortiz-Flores, AE, Luque-Ramírez, M, Fernández-Durán, E, Alvarez-Blasco, F, Escobar-Morreale, HF
Metabolism: clinical and experimental. 2019;:86-92
Abstract
BACKGROUND The risk of developing prediabetes and type 2 diabetes (dysglycemia) may be increased in women with PCOS. Whether an oral glucose tolerance test (OGTT) should be performed routinely in all PCOS women at presentation or should be recommended only to a selected subset of patients is still controversial. BASIC PROCEDURES At a tertiary care center, we conducted a retrospective, observational study including 400 women with PCOS submitted to an OGTT. Our primary objective was to assess the diagnostic agreement between two algorithms commonly used for the screening of dysglycemia in these women: i) relying only on fasting plasma glucose (FPG) or ii) considering both fasting and/or 120-min plasma glucose concentrations during an OGTT. We conducted the analysis considering all patients as a whole, and also after stratifying them by body weight, androgen concentrations and age. MAIN FINDINGS The OGTT detected dysglycemia in 24.5% of patients, whereas only 14.3% women would have been diagnosed using FPG levels alone. The latter missed as many as 40% of women with dysglycemia in our series, including all cases of diabetes. Diagnostic agreement between both algorithms was only 0.55 (κ = 0.103; 95% CI: 0.05-0.16). Areas under the receiver operating characteristic curve for dysglycemia were 0.86 (95%CI: 0.81-0.91) for FPG and 0.91 (95%CI = 0.87-0.95) for 120-min plasma glucose during the OGTT. FPG was not accurate in predicting dysglycemia in women with PCOS regardless of the presence of insulin resistance, weight excess, hyperandrogenemia and age. PRINCIPAL CONCLUSIONS Relying on FPG alone is not adequate for the screening of disorders of glucose tolerance in women with PCOS; such diagnosis should rely on the results of an OGTT regardless of age, weight and/or androgen concentrations.
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Individuals With Prediabetes Display Different Age-Related Pathophysiological Characteristics.
Fiorentino, TV, Pedace, E, Succurro, E, Andreozzi, F, Perticone, M, Sciacqua, A, Perticone, F, Sesti, G
The Journal of clinical endocrinology and metabolism. 2019;(7):2911-2924
Abstract
CONTEXT Impaired fasting glucose (IFG) and impaired glucose tolerance (IGT) are highly pathophysiologic heterogeneous prediabetes conditions that can occur in all age groups, from youth to elderly people. OBJECTIVE We evaluated whether distinct age-related phenotypes exist among individuals with IFG or IGT. RESEARCH DESIGN 479 young (aged 18 to 35 years), 699 adult (45 to 55 years) and 240 older (≥65 years) subjects underwent an oral glucose tolerance test (OGTT). From the OGTT results, the participants were grouped as follows: young age and normal glucose tolerance (NGT), adult age and NGT, older age and NGT, IFG young subjects, IFG adult subjects, IFG older subjects, IGT young (Y-IGT) subjects, IGT adult (A-IGT) subjects, and IGT older (O-IGT) subjects. MAIN OUTCOME MEASURES Insulin sensitivity and secretion, insulin clearance, and β-cell function. RESULTS Peripheral insulin sensitivity assessed using the Matsuda index, basal and glucose-stimulated insulin secretion, and β-cell function estimated using the disposition index were decreased in IFG adult subjects and IFG older subjects compared with IFG young subjects. A-IGT and Y-IGT subjects exhibited a progressively greater degree of hepatic insulin resistance assessed using the liver insulin resistance index, and reduced insulin clearance compared with O-IGT subjects. In contrast, the Matsuda index did not differ among Y-IGT, A-IGT, and O-IGT subjects. Basal and glucose-stimulated insulin secretion and β-cell function were lower in A-IGT and O-IGT subjects compared with Y-IGT individuals. CONCLUSIONS Subjects with IFG or IGT exhibited different age-related pathophysiologic characteristics. A more precise phenotyping of subjects with IGT or IFG could help to better design individualized preventive approaches to counteract diabetes progression.
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The main mechanism associated with progression of glucose intolerance in older patients with cystic fibrosis is insulin resistance and not reduced insulin secretion capacity.
Colomba, J, Boudreau, V, Lehoux-Dubois, C, Desjardins, K, Coriati, A, Tremblay, F, Rabasa-Lhoret, R
Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society. 2019;(4):551-556
Abstract
BACKGROUND Aging cystic fibrosis (CF) patients are at high risk of developing CF-related diabetes (CFRD). Decrease in insulin secretion over time is the main hypothesis to explain this increasing prevalence but mechanisms are still not well elucidated. The objective is to assess evolution of glucose tolerance and insulin secretion/sensitivity in aging CF patients. METHODS This is a retro-prospective observational analysis in the older adult CF patients from the Montreal Cystic Fibrosis Cohort (n = 46; at least 35 years old at follow-up) and followed for at least 4 years. Baseline and follow-up (last visit to date) 2-h oral glucose tolerance test (OGTT with glucose and insulin measurements every 30 min) were performed. Pulmonary function test (FEV1) and anthropometric data were measured the same day. Insulin sensitivity was measured by the Stumvoll index. RESULTS After a mean follow-up of 9.9 ± 2.6 years, mean age at follow-up was 43.5 ± 8.1 years old. An increase of body weight (+2.6 ± 6.5 kg, p = 0.01) and a decrease in pulmonary function (FEV1; 73.4 ± 21.2% to 64.5 ± 22.4%, p ≤ 0.001) were observed. Overall, insulin secretion is maintained at follow-up but all OGTT glucose values increased (for all values, p ≤ 0.028). At follow-up, 28.3% of patients had a normal glucose tolerance while 71.7% had abnormal glucose tolerance (AGT). AGT patients decreased their insulin sensitivity over time (p = 0.029) while it remained the same in NGT patients (p = 0.917). CONCLUSION In older CF patients, the progression of impaired glucose tolerance is occurring with stable insulin secretion but reduced insulin sensitivity.
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Effect of Short-Term Increase in Meal Frequency on Glucose Metabolism in Individuals with Normal Glucose Tolerance or Impaired Fasting Glucose: A Randomized Crossover Clinical Trial.
Hibi, M, Hari, S, Yamaguchi, T, Mitsui, Y, Kondo, S, Katashima, M
Nutrients. 2019;(9)
Abstract
Effects of meal frequency on blood glucose levels and glucose metabolism were evaluated over 3 days in adult males with normal glucose tolerance (NGT, n = 9) or impaired fasting glucose (IFG, n = 9) in a randomized, crossover comparison study. Subjects were provided with an isocaloric diet 3 times daily (3M) or 9 times daily (9M). Blood glucose was monitored on Day 3 using a continuous glucose monitoring system, and subjects underwent a 75-g oral glucose tolerance test (OGTT) on Day 4. Daytime maximum blood glucose, glucose range, duration of glucose ≥180 mg/dL, and nighttime maximum glucose were significantly lower in the NGT/9M condition than in the NGT/3M condition. Similar findings were observed in the IFG subjects, with a lower daytime and nighttime maximum glucose and glucose range, and a significantly higher daytime minimum glucose in the 9M condition than in the 3M condition. The OGTT results did not differ significantly between NGT/3M and NGT/9M conditions. In contrast, the incremental area under the curve tended to be lower and the maximum plasma glucose concentration was significantly lower in the IFG/9M condition than in the IFG/3M condition. In IFG subjects, the 9M condition significantly improved glucose metabolism compared with the 3M condition. Higher meal frequency may increase glucagon-like peptide 1 secretion and improve insulin secretion.
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Effectiveness of digital health using the transtheoretical model to prevent or delay type 2 diabetes in impaired glucose tolerance patients: protocol for a randomized control trial.
Alzeidan, R, Shata, Z, Hassounah, MM, Baghdadi, LR, Hersi, A, Fayed, A, Kashour, T, Elmorshedy, H
BMC public health. 2019;(1):1550
Abstract
BACKGROUND There is high prevalence of prediabetes and type 2 diabetes mellitus (T2DM) in Saudi Arabia that is still increasing. Early diagnosis of prediabetes, and immediate, effective intervention is yet unestablished. Conventional health promotion approaches are used to educate prediabetic patients. Behavior modification is very effective in prediabetics to delay T2DM. Thus, the main objective of this study is to examine the effect of the new behavioral model, the Transtheoretical Model short messages (text 4 change) to modify lifestyle to prevent or delay the onset of T2DM, through promotion of a healthy diet and increased physical activity, in impaired glucose tolerance patients. Another objective is to estimate the impact of this model on markers of cardiovascular and metabolic risks as T2DM is one of the modifiable risk factors to prevent cardiovascular diseases. METHODS This is a randomized controlled trial. One thousand and sixteen, eligible Saudi adults will be recruited from the Heart Health Promotion study (HHP), which was conducted at the King Saud University from July 2013 to April 2014. These adults were at a higher risk of developing T2DM within 2-3 years. The research team's database has a contact list and they will recruit individuals over 6-8 weeks. All participants will be randomized at a 1:1 ratio into two groups, receive group education about lifestyle modifications and written information about diet and physical activity. Text 4 change SMS texts will be sent only to the intervention group. All participants will be assessed at baseline, 6, 12, 18, 24, 30, and 36 months for behavioral change using a World Health Organization (WHO) STEPS questionnaire and for glycated hemoglobin, biochemical and anthropometric measurements using standard methods. DISCUSSION This new approach for promoting the importance of behavior modification in prediabetics is expected to delay and/or prevent the development of T2DM in Saudi Arabia, subsequently reducing the risk of cardiovascular morbidity and mortality too. Results from this study will promote an innovative and high-tech way to decrease the burden of cardiovascular diseases in Saudi Arabia. TRIAL REGISTRATION International Standard Randomized Control Trial, registration number ISRCTN10857643. Registered 4 June, 2018.
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Morbidity and mortality after lifestyle intervention for people with impaired glucose tolerance: 30-year results of the Da Qing Diabetes Prevention Outcome Study.
Gong, Q, Zhang, P, Wang, J, Ma, J, An, Y, Chen, Y, Zhang, B, Feng, X, Li, H, Chen, X, et al
The lancet. Diabetes & endocrinology. 2019;(6):452-461
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Abstract
BACKGROUND Lifestyle interventions can delay the onset of type 2 diabetes in people with impaired glucose tolerance, but whether this leads subsequently to fewer complications or to increased longevity is uncertain. We aimed to assess the long-term effects of lifestyle interventions in people with impaired glucose tolerance on the incidence of diabetes, its complications, and mortality. METHODS The original study was a cluster randomised trial, started in 1986, in which 33 clinics in Da Qing, China, were randomly assigned to either be a control clinic or provide one of three interventions (diet, exercise, or diet plus exercise) for 6 years for 577 adults with impaired glucose tolerance who usually receive their medical care from the clinics. Subsequently, participants were followed for up to 30 years to assess the effects of intervention on the incidence of diabetes, cardiovascular disease events, composite microvascular complications, cardiovascular disease death, all-cause mortality, and life expectancy. FINDINGS Of the 577 participants, 438 were assigned to an intervention group and 138 to the control group (one refused baseline examination). After 30 years of follow-up, 540 (94%) of 576 participants were assessed for outcomes (135 in the control group, 405 in the intervention group). During the 30-year follow-up, compared with control, the combined intervention group had a median delay in diabetes onset of 3·96 years (95% CI 1·25 to 6·67; p=0·0042), fewer cardiovascular disease events (hazard ratio 0·74, 95% CI 0·59-0·92; p=0·0060), a lower incidence of microvascular complications (0·65, 0·45-0·95; p=0·025), fewer cardiovascular disease deaths (0·67, 0·48-0·94; p=0·022), fewer all-cause deaths (0·74, 0·61-0·89; p=0·0015), and an average increase in life expectancy of 1·44 years (95% CI 0·20-2·68; p=0·023). INTERPRETATION Lifestyle intervention in people with impaired glucose tolerance delayed the onset of type 2 diabetes and reduced the incidence of cardiovascular events, microvascular complications, and cardiovascular and all-cause mortality, and increased life expectancy. These findings provide strong justification to continue to implement and expand the use of such interventions to curb the global epidemic of type 2 diabetes and its consequences. FUNDING US Centers for Disease Control and Prevention, WHO, Chinese Center for Disease Control and Prevention, World Bank, Ministry of Public Health of the People's Republic of China, Da Qing First Hospital, China-Japan Friendship Hospital, and National Center for Cardiovascular Diseases & Fuwai Hospital.
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Dipeptidyl Peptidase 4 Activity Is Related to Body Composition, Measures of Adiposity, and Insulin Resistance in Subjects with Excessive Adiposity and Different Degrees of Glucose Tolerance.
Silva Júnior, WS, Souza, MDGC, Nogueira Neto, JF, Bouskela, E, Kraemer-Aguiar, LG
Journal of diabetes research. 2019;:5238013
Abstract
BACKGROUND The enzyme dipeptidyl peptidase 4 (DPP4) has been recently recognized as an adipo-myokine. However, studies that associate its constitutive activity with body composition, anthropometry, and insulin resistance (IR) are very scarce and included only healthy people. METHODS First, we investigated the relationships of constitutive DPP4 activity, body composition (assessed by bioelectrical impedance analysis), and measures of adiposity and IR in fifty-two subjects of both sexes, 18-50 years, and BMI ≥25.0 kg/m2 who comprised three groups according to glucose tolerance. Additionally, we evaluated associations among DPP4 activity and adipokines, gut peptides, and biochemical variables at fasting and 30 and 60 min after a standardized meal intake. RESULTS DPP4 activity was no different among the three groups. At fasting, pooled analysis showed it was positively correlated with measures of central adiposity, such as WC (P = 0.011) and WHR (P = 0.009), and with all measures of IR, but inversely related to indexes of general adiposity, such as fat mass percentage (P = 0.014) and BAI (P = 0.0003). DPP4 activity was also associated with lean mass (r = 0.57, P < 0.0001). After meal intake, DPP4 activity remained significantly associated with insulin, leptin, and resistin. In multiple regression analysis, BAI, WHR, percent lean mass, HOMA-IR, and leptin influenced DPP4 activity and explained approximately 26% of the variance on it. CONCLUSIONS Constitutive DPP4 activity is positively associated with lean mass, central adiposity, and IR and negatively to general adiposity. Furthermore, it seems to be influenced by body composition and IR and could also be viewed as an adipo-myokine in subjects with excessive adiposity and different stages of glucose tolerance.
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Gut-derived lipopolysaccharides increase post-prandial oxidative stress via Nox2 activation in patients with impaired fasting glucose tolerance: effect of extra-virgin olive oil.
Carnevale, R, Pastori, D, Nocella, C, Cammisotto, V, Bartimoccia, S, Novo, M, Del Ben, M, Farcomeni, A, Angelico, F, Violi, F
European journal of nutrition. 2019;(2):843-851
Abstract
PURPOSE Post-prandial phase is characterized by enhanced oxidative stress but the underlying mechanism is unclear. We investigated if gut-derived lipopolysaccharide (LPS) is implicated in this phenomenon and the effect of extra virgin olive oil (EVOO) in patients with impaired fasting glucose (IFG). METHODS This is a randomized cross-over interventional study including 30 IFG patients, to receive a lunch with or without 10 g of EVOO. Serum LPS, Apo-B48, markers of oxidative stress such as oxidized LDL (oxLDL) and soluble Nox2-derived peptide (sNox2-dp), a marker of nicotinamide-adenine-dinucleotide-phosphate oxidase isoform Nox2 activation, and plasma polyphenols were determined before, 60 and 120 min after lunch. RESULTS In patients not given EVOO oxidative stress as assessed by sNox2-dp and oxLDL significantly increased at 60 and 120 min concomitantly with an increase of LPS and Apo-B48. In these patients, changes of LPS were correlated with Apo-B48 (Rs = 0.542, p = 0.002) and oxLDL (Rs = 0.463, p = 0.010). At 120 min, LPS (β - 15.73, p < 0.001), Apo-B48 (β - 0.14, p = 0.004), sNox2-dp (β - 5.47, p = 0.030), and oxLDL (β - 42.80, p < 0.001) significantly differed between the two treatment groups. An inverse correlation was detected between polyphenols and oxLDL (R - 0.474, p < 0.005). In vitro study showed that LPS, at the same concentrations found in the human circulation, up-regulated Nox2-derived oxidative stress via interaction with Toll-like receptor 4. CONCLUSIONS Post-prandial phase is characterized by an oxidative stress-related inflammation potentially triggered by LPS, a phenomenon mitigated by EVOO administration.
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Alpha-glucosidase inhibitors for prevention or delay of type 2 diabetes mellitus and its associated complications in people at increased risk of developing type 2 diabetes mellitus.
Moelands, SV, Lucassen, PL, Akkermans, RP, De Grauw, WJ, Van de Laar, FA
The Cochrane database of systematic reviews. 2018;(12):CD005061
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Abstract
BACKGROUND Alpha-glucosidase inhibitors (AGI) reduce blood glucose levels and may thus prevent or delay type 2 diabetes mellitus (T2DM) and its associated complications in people at risk of developing of T2DM. OBJECTIVES To assess the effects of AGI in people with impaired glucose tolerance (IGT), impaired fasting blood glucose (IFG), moderately elevated glycosylated haemoglobin A1c (HbA1c) or any combination of these. SEARCH METHODS We searched CENTRAL, MEDLINE, Embase, ClinicalTrials.gov, the World Health Organization International Clinical Trials Registry Platform, and the reference lists of systematic reviews, articles and health technology assessment reports. The date of the last search of all databases was December 2017. SELECTION CRITERIA We included randomised controlled trials (RCTs), with a duration of one year or more, comparing AGI with any pharmacological glucose-lowering intervention, behaviour-changing intervention, placebo or no intervention in people with IFG, IGT, moderately elevated HbA1c or combinations of these. DATA COLLECTION AND ANALYSIS Two review authors read all abstracts and full-text articles or records, assessed quality and extracted outcome data independently. One review author extracted data, which were checked by a second review author. We resolved discrepancies by consensus or involvement of a third review author. For meta-analyses we used a random-effects model with assessment of risk ratios (RRs) for dichotomous outcomes and mean differences (MDs) for continuous outcomes, using 95% confidence intervals (CIs) for effect estimates. We assessed the overall quality of the evidence by using the GRADE instrument. MAIN RESULTS For this update of the Cochrane Review (first published 2006, Issue 4) we included 10 RCTs (11,814 participants), eight investigating acarbose and two investigating voglibose, that included people with IGT or people "at increased risk for diabetes". The trial duration ranged from one to six years. Most trials compared AGI with placebo (N = 4) or no intervention (N = 4).Acarbose reduced the incidence of T2DM compared to placebo: 670 out of 4014 people (16.7%) in the acarbose groups developed T2DM, compared to 812 out of 3994 people (20.3%) in the placebo groups (RR 0.82, 95% CI 0.75 to 0.89; P < 0.0001; 3 trials; 8008 participants; moderate-certainty evidence). One trial including participants with coronary heart disease and IGT contributed 64% of cases for this outcome. Acarbose reduced the risk of T2DM compared to no intervention: 7 out 75 people (9.3%) in the acarbose groups developed T2DM, compared to 18 out of 65 people (27.7%) in the no-intervention groups (RR 0.31, 95% CI 0.14 to 0.69; P = 0.004; 2 trials; 140 participants; very low-certainty evidence).Acarbose compared to placebo did not reduce or increase the risk of all-cause mortality (RR 0.98, 95% CI 0.82 to 1.18; P = 0.86; 3 trials; 8069 participants; very low-certainty evidence), cardiovascular mortality (RR 0.88; 95% CI 0.71 to 1.10; P = 0.26; 3 trials; 8069 participants; very low-certainty evidence), serious adverse events (RR 1.12, 95% CI 0.97 to 1.29; P = 0.13; 2 trials; 6625 participants; low-certainty evidence), non-fatal stroke (RR 0.50, 95% CI 0.09 to 2.74; P = 0.43; 1 trial; 1368 participants; very low-certainty evidence) or congestive heart failure (RR of 0.87; 95% CI 0.63 to 1.12; P = 0.40; 2 trials; 7890 participants; low-certainty evidence). Acarbose compared to placebo reduced non-fatal myocardial infarction: one out of 742 participants (0.1%) in the acarbose groups had a non-fatal myocardial infarction compared to 15 out of 744 participants (2%) in the placebo groups (RR 0.10, 95% CI 0.02 to 0.53; P = 0.007; 2 trials; 1486 participants; very low-certainty evidence). Acarbose treatment showed an increased risk of non-serious adverse events (mainly gastro-intestinal events), compared to placebo: 751 of 775 people (96.9%) in the acarbose groups experienced an event, compared to 723 of 775 people (93.3%) in the placebo groups (RR 1.04; 95% CI 1.01 to 1.06; P = 0.0008; 2 trials; 1550 participants). Acarbose compared to no intervention showed no advantage or disadvantage for any of these outcome measures (very low-certainty evidence).One trial each compared voglibose with placebo (1780 participants) or diet and exercise (870 participants). Voglibose compared to placebo reduced the incidence of T2DM: 50 out of 897 participants (5.6%) developed T2DM, compared to 106 out of 881 participants (12%) in the placebo group (RR 0.46, 95% CI 0.34 to 0.64; P < 0.0001; 1 trial; 1778 participants; low-certainty evidence). For all other reported outcome measures there were no clear differences between voglibose and comparator groups. One trial with 90 participants compared acarbose with diet and exercise and another trial with 98 participants reported data on acarbose versus metformin. There were no clear differences for any outcome measure between these two acarbose interventions and the associated comparator groups.None of the trials reported amputation of lower extremity, blindness or severe vision loss, end-stage renal disease, health-related quality of life, time to progression to T2DM, or socioeconomic effects. AUTHORS' CONCLUSIONS AGI may prevent or delay the development of T2DM in people with IGT. There is no firm evidence that AGI have a beneficial effect on cardiovascular mortality or cardiovascular events.