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Policaptil Gel Retard in adult subjects with the metabolic syndrome: Efficacy, safety, and tolerability compared to metformin.
Guarino, G, Della Corte, T, Strollo, F, Gentile, S, ,
Diabetes & metabolic syndrome. 2021;(3):901-907
Abstract
BACKGROUND Policaptil Gel Retard® (PGR), is a new macromolecule complex based on polysaccharides slowing the rate of carbohydrate and fat absorption. It proved to significantly reduce body weight, acanthosis nigricans expression, HbA1c levels, and glucose metabolism abnormalities in obese, hyper-insulinemic adolescents. No such data are available for adults. AIM: to compare the effects of PGR vs. metformin in adult subjects with the Metabolic Syndrome (MS) and T2DM on a Low Glycemic Index diet. SUBJECTS AND METHODS This spontaneous clinical, longitudinal, single-blind, randomized study based on a per-protocol analysis enrolled 100 outpatients with MS and T2DM consecutively referring to our clinic for three months, and randomly assigned to either the active treatment (Group A:, 6 tablets/day) or the comparator (Group B: Metformin tablets, 1500-2000 mg/day in two divided doses during the two main meals, to minimize side effects) to be taken 30 min before each main meal in equally divided doses. Serum lipid profile, anthropometry, HOMA-IR index, and tolerability parameters were evaluated before and after a 6-month follow-up period. RESULTS all parameters improved at a similar rate in both groups but for the lipid profile, which got even better in Group A. Group A also experienced less prominent gastrointestinal side effects than its counterpart. CONCLUSION For the first time, we showed the non-inferiority of PGR compared to metformin in obese adult subjects with the MS and T2DM as for glycemic control and a clear-cut superiority of PGR in terms of both serum lipid-lowering capacity and tolerability.
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Lower versus standard sucrose dose for treating hypoglycemia in patients with type 1 diabetes mellitus in therapy with predictive low glucose suspend (PLGS) augmented insulin pumps: A randomized crossover trial in Santiago, Chile.
Grassi, B, Onetto, MT, Zapata, Y, Jofré, P, Echeverría, G
Diabetes & metabolic syndrome. 2021;(3):695-701
Abstract
BACKGROUND AND AIMS Recommended hypoglycemia treatment in adults with T1D consists of 15 g of rapid absorption carbohydrates. We aimed to evaluate the response to fewer carbohydrates for treating hypoglycemia in patients with T1D on insulin pumps with predictive suspension technology (PLGS). METHODS T1D patients on insulin pumps with PLGS were randomized to receive 10 or 15 g of sucrose per hypoglycemia for two weeks (S10 and S15 groups, respectively) when capillary blood glucose (BG) was <70 mg/dL, with crossover after two weeks. Evolution of capillary BG, active insulin, and suspension time were assessed. RESULTS 59 hypoglycemic episodes were analyzed, 33 in S10 and 26 in S15. Baseline BG in S10 was 54.3 ± 7.7 mg/dL versus 56.9 ± 8.8 in S15 (p = 0,239). Active insulin, present in 85% of the episodes, and PLGS suspension time were similar between groups. BG at 15 min was 77 mg/dL in S10 and 95 mg/dL in S15 (p = 0.0007). In S10, 21% of the episodes required to repeat the treatment after 15 min compared with none on S15, with a RR of 0,79 (95% CI 0.66, 0.940, p = 0,014) for successfully treating the episode. Sensor glucose was significantly different from BG at the moment of the hypoglycemia and control 15 min after treatment. No severe hypoglycemia and no rebound hyperglycemia occurred in neither group. CONCLUSIONS A hypoglycemia treatment protocol with a lower dose of sucrose might be insufficient despite PLGS technology. Our data suggest that standard doses of sucrose should still be recommended.
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11β Hydroxysteroid dehydrogenase - 1 activity in type 2 diabetes mellitus: a comparative study.
Shukla, R, Basu, AK, Mandal, B, Mukhopadhyay, P, Maity, A, Chakraborty, S, Devrabhai, PK
BMC endocrine disorders. 2019;(1):15
Abstract
BACKGROUND A comparative study of 11 β HSD 1 activity in type 2 diabetes mellitus subjects with respect to fasting blood glucose and other metabolic parameters was conducted. METHODS A case control experimental study was performed enrolling thirty type 2 diabetes mellitus patients and thirty age, gender and BMI matched controls using cortisone acetate test. RESULTS The rise of serum cortisol after oral 25 mg cortisone acetate from baseline (dexamethasone suppressed level) is higher in subjects with type 2 diabetes and is associated with exercise, BMI, SGOT but not daily calorie intake, lipid parameters and thyroid status. Fasting blood glucose after overnight 1 mg oral dexamethasone is a strong predictor of 11HSD1 activity, irrespective of presence of type 2 diabetes. CONCLUSION 11β HSD 1 activity is higher in type 2 diabetes mellitus subjects, especially those who are lean. Future 11 β HSD 1 inhibitors targeting metabolic syndrome, will be most useful in those with increased fasting blood glucose. The role of DHEAS and vitamin D status needs to be explored.
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Among young Sri Lankan patients with diabetes, how do lipid profiles differ between those with and without metabolic syndrome?
Katulanda, GW, Dissanayake, HA, Katulanda, P, Matthews, DR, Shine, B
Diabetes & metabolic syndrome. 2019;(5):3057-3063
Abstract
AIMS: Metabolic syndrome (MetS) is a risk factor for cardiovascular disease (CVD). Apolipoproteins are emerging as powerful predictors of CVD. We aimed to study associations of metabolic syndrome and apoB, apoAI, apoB/AI ratio in young Sri Lankans with type 2 diabetes. MATERIALS & METHODS Blood samples were available from 690 patients with type 2 diabetes in Sri Lanka Young Diabetes Study, and were analysed for apoB, apoAI, total cholesterol (TC), high-density lipoprotein cholesterol (HDLC), triglycerides (TG) and glycated haemoglobin (HbA1c). Their associations with MetS as perNCEP/ATPIII criteria were studied. RESULTS MetS was present in 60.9% of subjects. Of those with MetS, 76.0% were women. Those with MetS had higher apoB (1.27 V s 1.19 mmol/L; p = 0.001), apoB/AI (0.80 V s 0.75; p = 0.001), non-HDL cholesterol (NHDLC) (4.15 V s 3.98 mmol/L; p = 0.002),and triglycerides (1.51 V s 1.31 mmol/L; p < 0.001) and lower apoAI (1.58 V s 1.60 mmol/L; p = 0.03) and HDLC (1.02 V s 1.16 mmol/L, p < 0.001). ApoB and apoB/AIlevels increased significantly as the number of MetS components increased. ApoB and apoB:AI ratio were independently associated with MetS and components. CONCLUSION MetS showed a high prevalence among young Sri Lankans with diabetes. Elevated apoB is commonly clustered with other risk indicators in MetS.
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Polymorphisms of the FTO and MTHFR genes and vascular, inflammatory and metabolic marker levels in postmenopausal women.
Chedraui, P, Pérez-López, FR, Escobar, GS, Espinoza-Caicedo, JA, Montt-Guevara, M, Genazzani, AR, Simoncini, T, ,
Journal of endocrinological investigation. 2016;(8):885-90
Abstract
OBJECTIVE To determine the prevalence of three single nucleotide polymorphisms (SNPs) in postmenopausal women with and without the metabolic syndrome (METS) and to explore levels of circulating biomarkers of inflammation, vascular and metabolic dysfunction according to SNP genotypes. METHODS DNA was extracted from the whole blood of 192 natural postmenopausal women (40 to 65 years) screened for the METS and tested for three gene SNPs related to obesity: the fat mass obesity (FTO: rs9939609) and the methylenetetrahydrofolate reductase (MTHFR C677T and A1298C). Blood levels of angiopoietin, IL-8, sFASL, IL-6, TNF-α, sCD40L, PAI-1, u-PA, leptin, adiponectin, resistin, ghrelin, visfatin, adipsin and insulin were measured in a subgroup, with and without the METS, using multiplex technology (n = 100) and compared according to SNP genotypes. RESULTS Genotype frequency of the three studied SNPs did not differ in relation to the presence of the METS. However, genotypes CT+TT (C677T) and AT (rs9939609) were more prevalent in women with high triglyceride levels. Pooled sub-analysis (n = 100) found that median sCD40L and visfatin levels were higher in women with genotypes AT+TT (rs9939609) as compared to AA (1178 vs. 937.0 pg/mL and 0.93 vs. 0.43 ng/mL, respectively, p < 0.05). CONCLUSION Two SNP genotypes related to obesity were more prevalent in women with abnormal triglyceride levels and two vascular and inflammatory serum markers were higher in relation to the rs9939609 SNP.
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Effects of high adherence to mediterranean or low-fat diets in medicated secondary prevention patients.
Thomazella, MC, Góes, MF, Andrade, CR, Debbas, V, Barbeiro, DF, Correia, RL, Marie, SK, Cardounel, AJ, daLuz, PL, Laurindo, FR
The American journal of cardiology. 2011;(11):1523-9
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Abstract
Although the Mediterranean diet (MD) and the low-fat Therapeutic Lifestyle Changes Diet (TLCD) promote equivalent increases in event-free survival in secondary coronary prevention, possible mechanisms of such complete dietary patterns in these patients, usually medicated, are unclear. The aim of this study was to investigate the effects of the MD versus the TLCD in markers of endothelial function, oxidative stress, and inflammation after acute coronary syndromes. Comparison was made between 3 months of the MD (n = 21; rich in whole grains, vegetables, fruits, nuts, and olive oil, plus red wine) and the TLCD (n = 19; plus phytosterols 2 g/day) in a highly homogenous population of stable patients who experienced coronary events in the previous 2 years (aged 45 to 65 years, all men) allocated to each diet under a strategy designed to optimize adherence, documented as >90%. Baseline demographics, body mass index and clinical data, and use of statins and other drugs were similar between groups. The MD and TLCD promoted similar decreases in body mass index and blood pressure (p ≤0.001) and particularly in plasma asymmetric dimethylarginine levels (p = 0.02) and l-arginine/asymmetric dimethylarginine ratios (p = 0.01). The 2 diets did not further enhance flow-mediated brachial artery dilation compared to baseline (4.4 ± 4.0%). Compared to the TLCD, the MD promoted decreases in blood leukocyte count (p = 0.025) and increases in high-density lipoprotein levels (p = 0.053) and baseline brachial artery diameter. Compared to the MD, the TLCD decreased low-density lipoprotein and oxidized low-density lipoprotein plasma levels, although the ratio of oxidized to total low-density lipoprotein remained unaltered. Glucose, high-sensitivity C-reactive protein, triglycerides, myeloperoxidase, intercellular adhesion molecular, vascular cell adhesion molecule, and glutathione serum and plasma levels remained unchanged with either diet. In conclusion, medicated secondary prevention patients show evident although small responses to the MD and the TLCD, with improved markers of redox homeostasis and metabolic effects potentially related to atheroprotection.