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The cost-effectiveness of metformin in pre-diabetics: a systematic literature review of health economic evaluations.
Gebregergish, SB, Hashim, M, Heeg, B, Wilke, T, Rauland, M, Hostalek, U
Expert review of pharmacoeconomics & outcomes research. 2020;(2):207-219
Abstract
Objectives: Our aim was to systematically identify and appraise cost-effectiveness studies of metformin in prediabetic subjects.Methods: A systematic literature review was conducted and reported according to standard guidlines. The search was conducted in PubMed, Embase, International Society for Pharmacoeconomics and Outcomes Research (ISPOR) presentation database and the Cost-Effectiveness Analysis (CEA) and Center for Reviews and Dissemination (CRD) registries. All cost-effectiveness studies assessing metformin in prediabetic patients were included.Results: Twenty-three reports were included. Metformin and intensive lifestyle changes (ILC) interventions were always cost-effective compared to placebo. ILC was cost-effective and sometimes dominant compared to metformin. Metformin was cost-saving compared to ILC in the short and medium-term. Although, in the long term, metformin was more expensive than ILC in terms of direct medical costs, when indirect non-medical costs are included, metformin less expensive than ILC. One study reported that for patients with Body Mass Index (BMI) higher than 30 kg/m2, metformin is a cost-effective strategy compared to placebo and ILC. However, this finding was not confirmed by other retrieved studies.Conclusion: ILC is cost-effective compared to metformin and, both of them are cost-effective compared to placebo. Metformin may be cost-saving in the short- to medium-term and possibly in the long-term.
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Macular thinning in prediabetes or type 2 diabetes without diabetic retinopathy: the Maastricht Study.
De Clerck, EEB, Schouten, JSAG, Berendschot, TTJM, Goezinne, F, Dagnelie, PC, Schaper, NC, Schram, MT, Stehouwer, CDA, Webers, CAB
Acta ophthalmologica. 2018;(2):174-182
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PURPOSE To assess macular thinning in individuals with prediabetes or type 2 diabetes without diabetic retinopathy (DM2 w/o DR) compared with individuals with normal glucose metabolism (NGM). METHODS Using spectral domain optical coherence tomography (SD-OCT), we measured macular thickness in six subfields as defined by the Early Treatment Diabetic Retinopathy Study (ETDRS) in 1838 participants from The Maastricht Study, a population-based cohort study (mean age 59 ± 8 years, 49% men, 1087 NGM, 279 prediabetes, 472 DM2 w/o DR). Multivariable linear regression was used to assess the association between macular thickness and glucose metabolism status. RESULTS After adjustment for age, sex and spherical equivalent, individuals with prediabetes showed a significant decrease in pericentral superior macular thickness [β = -2.14 μm (95% confidence interval (CI): -4.24 to -0.03), p < 0.05] compared with individuals with NGM. In individuals with DM2 w/o DR, the fovea [β = -4.05 μm (95% CI: -6.30 to -1.79), p < 0.001] and the four pericentral quadrants (range: β = -4.64 to -5.29 μm, p < 0.001) were significantly thinner compared with individuals with NGM. There was a significant linear trend of macular thinning with severity of glucose metabolism status in five subfields (p < 0.001). CONCLUSION Macular thickness is reduced in prediabetes and a greater reduction occurs in DM2, even before DR is clinically present. About half of the thinning observed in DM2 w/o DR was already found in prediabetes. Generalized thinning of the macula could be related to thinning of the temporal side of the optic nerve head through the connecting papillo-macular bundle.
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Reference intervals for C-peptide and insulin derived from a general adult Danish population.
Larsen, PB, Linneberg, A, Hansen, T, Friis-Hansen, L
Clinical biochemistry. 2017;(7-8):408-413
Abstract
BACKGROUND Despite international efforts to standardize C-peptide and insulin calibrators and immunoassays, platform dependent differences still exist, and platform specific reference intervals are hence needed for correct interpretation. We therefore wanted to establish traceable reference intervals for C-peptide and insulin. METHODS In 623 consecutively recruited participants, insulin and C-peptide were measured using the Cobas e411 (Roche Diagnostics, Switzerland). Participants with diabetes were excluded (fasting Glucose ≥7.0mmol/L or HbA1c≥6.5%/≥48mmol/L) and reference intervals were calculated with and without the inclusion of persons who were prediabetic, according to two definitions (The World Health Organization (WHO) and American Diabetes Association (ADA)). To ensure the correctness of calibration, the control pools were analyzed by a reference laboratory. The reference intervals were calculated according to the IFCC guidelines, using the RefVal software (Solberg, Oslo, Norway). RESULTS Comparison of our results with those from the reference laboratory revealed equivalence for C-peptide results whereas the insulin determined on the Cobas e411 assay were 15-20% higher. The difference is attributed to an incorrect conversion factor for converting from activity to metric units. The Cobas e411 assay uses the factor 6.945 for converting from U/mL to pmol/L. This is in disagreement with the biological activity of insulin which is 166.8×106IU/mol or 6.00nmol/IU. CONCLUSION We successfully established reference intervals for C-peptide and insulin for non-diabetic and prediabetic participants. The reference intervals for fasting C-peptide and fasting insulin are ready for implementation. A recertification of the insulin standards is needed.
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Metabolic responses of healthy or prediabetic adults to bovine whey protein and sodium caseinate do not differ.
Hoefle, AS, Bangert, AM, Stamfort, A, Gedrich, K, Rist, MJ, Lee, YM, Skurk, T, Daniel, H
The Journal of nutrition. 2015;(3):467-75
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BACKGROUND Casein is considered a slowly digestible protein compared with whey protein, and this may cause differences in hormone responses and the kinetics of delivering amino acids into the circulation. OBJECTIVE We investigated whether postprandial plasma hormone and metabolite responses were different when bovine casein or whey protein was co-administered with carbohydrates in healthy and prediabetic adults. METHODS White healthy male adults (n = 15) and white, well-defined male and female prediabetic adults (n = 15) received test drinks randomly on 3 different occasions at least 2 d apart which contained 50 g of maltodextrin19 (MD19) alone or in combination with 50 g of whey protein isolate (WPI) or 50 g of sodium caseinate (SC). Blood samples were collected over a 240-min time period and were analyzed for hormone profiles and defined metabolites. RESULTS No evidence was found that gastric emptying was different between the 2 protein drinks. Both proteins increased peak plasma insulin concentrations in prediabetic persons by 96% compared with MD19 (each, P < 0.05), which was accompanied by a reduction of peak venous blood glucose by 21% (each, P < 0.0001) without a difference between the 2 proteins. Peak plasma glucagon concentrations increased by 101% in both groups after the protein drinks (P < 0.05). The WPI drink also increased peak plasma glucose-dependent insulinotropic polypeptide concentrations in healthy volunteers by 56% (P < 0.01). Differences in plasma metabolite concentrations in volunteers could be attributed exclusively to the differences in the amino acid composition of the 2 proteins ingested. CONCLUSION The WPI and the SC drinks similarly reduced postprandial glucose excursions when ingested with carbohydrates in healthy and prediabetic volunteers. Under our experimental conditions, however, no evidence was found that gastrointestinal processing of the 2 protein varieties differed substantially. This trial was registered at clinicaltrials.gov as DRKS00005682.
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[Mediterranean diet lowers diabetes risk].
Mai, K
MMW Fortschritte der Medizin. 2014;(10):35
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The effect of magnesium supplements on early post-transplantation glucose metabolism: a randomized controlled trial.
Van Laecke, S, Nagler, EV, Taes, Y, Van Biesen, W, Peeters, P, Vanholder, R
Transplant international : official journal of the European Society for Organ Transplantation. 2014;(9):895-902
Abstract
Post-transplantation hypomagnesemia is common and predicts diabetes. Magnesium improves glycemic control in diabetics and insulin sensitivity in insulin resistant subjects. We aimed to assess the effectiveness of oral magnesium for improving glycemic control and insulin sensitivity at 3 months post-transplantation. We conducted a single-center, open-label, randomized parallel group study. We included adults with serum magnesium <1.7 mg/dl within 2 weeks after kidney transplantation. We randomized participants to 450 mg magnesium oxide up to three times daily or no treatment. The primary endpoint was the mean difference in fasting glycemia. Secondary endpoints were the mean difference in area under the curve (AUC) of glucose during an oral glucose tolerance test and insulin resistance measured by Homeostasis Model of Assessment-Insulin Resistance (HOMA-IR). Analyses were on intention-to-treat basis. In patients randomized to magnesium oxide (N = 27) versus no treatment (N = 27), fasting glycemia on average was 11.5 mg/dl lower (95% CI 1.7 to 21.3; P = 0.02). There was no difference between the two groups neither for 2 h AUC, where the mean value was 1164 mg/dl/min (95% CI -1884 to 4284; P = 0.45) lower in the treatment group nor for HOMA-IR. Magnesium supplements modestly improved fasting glycemia without effect on insulin resistance. Higher baseline glycemia among patients in the control group may have driven the positive outcome (ClinicalTrials.gov number: NCT01889576).
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The Healthy Living Partnerships to Prevent Diabetes study: 2-year outcomes of a randomized controlled trial.
Katula, JA, Vitolins, MZ, Morgan, TM, Lawlor, MS, Blackwell, CS, Isom, SP, Pedley, CF, Goff, DC
American journal of preventive medicine. 2013;(4 Suppl 4):S324-32
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BACKGROUND Since the Diabetes Prevention Project (DPP) demonstrated that lifestyle weight-loss interventions can reduce the incidence of diabetes by 58%, several studies have translated the DPP methods to public health-friendly contexts. Although these studies have demonstrated short-term effects, no study to date has examined the impact of a translated DPP intervention on blood glucose and adiposity beyond 12 months of follow-up. PURPOSE To examine the impact of a 24-month, community-based diabetes prevention program on fasting blood glucose, insulin, insulin resistance as well as body weight, waist circumference, and BMI in the second year of follow-up. DESIGN An RCT comparing a 24-month lifestyle weight-loss program (LWL) to an enhanced usual care condition (UCC) in participants with prediabetes (fasting blood glucose=95-125 mg/dL). Data were collected in 2007-2011; analyses were conducted in 2011-2012. SETTING/PARTICIPANTS 301 participants with prediabetes were randomized; 261 completed the study. The intervention was held in community-based sites. INTERVENTION The LWL program was led by community health workers and sought to induce 7% weight loss at 6 months that would be maintained over time through decreased caloric intake and increased physical activity. The UCC received two visits with a registered dietitian and a monthly newsletter. MAIN OUTCOME MEASURES The main measures were fasting blood glucose, insulin, insulin resistance, body weight, waist circumference, and BMI. RESULTS Intent-to-treat analyses of between-group differences in the average of 18- and 24-month measures of outcomes (controlling for baseline values) revealed that the LWL participants experienced greater decreases in fasting glucose (-4.35 mg/dL); insulin (-3.01 μU/ml); insulin resistance (-0.97); body weight (-4.19 kg); waist circumference (-3.23 cm); and BMI (-1.40), all p-values <0.01. CONCLUSIONS A diabetes prevention program administered through an existing community-based system and delivered by community health workers is effective at inducing significant long-term reductions in metabolic indicators and adiposity.
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Comparative effectiveness of pioglitazone and rosiglitazone in type 2 diabetes, prediabetes, and the metabolic syndrome: a meta-analysis.
Norris, SL, Carson, S, Roberts, C
Current diabetes reviews. 2007;(2):127-40
Abstract
OBJECTIVE To assess the comparative efficacy and safety of pioglitazone and rosiglitazone. RESEARCH DESIGN AND METHODS Multiple electronic databases were searched for randomized, controlled trials (RCTs) of efficacy or effectiveness and for studies of any design which reported adverse events. Pooled estimates were calculated using a random effects model. RESULTS Eighty-seven RCTs fulfilled our inclusion criteria for efficacy or effectiveness and 42 studies examined safety or tolerability. Two head-to-head RCTs of type 2 diabetes demonstrated significant improvements in A1c in both groups at follow-up with no significant difference between groups; a third study found no significant change in A1c in either group. The pooled estimate of effect on A1c for pioglitazone compared to placebo was -0.99% (95% confidence interval [CI], -1.18, -0.81) and for rosiglitazone was -0.92% (95% CI, -1.2, -0.64). Indirect comparison revealed no significant difference in A1c (between-drug difference -0.07% [95% CI, -0.41, 0.27]). Rosiglitazone increased total cholesterol compared to pioglitazone (net between-drug effect 13.91 mg/dl [95% CI, 1.20 to 26.62]). Both drugs increased weight by 2 to 3 kg and rates of adverse events were similar for the two drugs. Data were insufficient to assess comparative effects on health outcomes such as cardiovascular events. CONCLUSIONS Based largely on indirect evidence, the two thiazolidinediones appear to have similar effects on glycemic control and similar side-effect profiles. Rosiglitazone may increase total cholesterol compared to pioglitazone. Studies are needed which provide direct comparisons between the two drugs, particularly for long-term health outcomes.