scholarly journals Ethynilestradiol 20 mcg plus Levonorgestrel 100 mcg: Clinical Pharmacology

2014 ◽  
Vol 2014 ◽  
pp. 1-9 ◽  
Author(s):  
Stefano Lello ◽  
Andrea Cavani
Keyword(s):  
Decision Making ◽  
Clinical Pharmacology ◽  
Body Composition ◽  
Body Weight ◽  
Placebo Group ◽  
Venous Thromboembolism ◽  
Glucose Metabolism ◽  
Low Dose ◽  
Treated Group ◽  
Clinical Effects

Estroprogestins (EPs) are combinations of estrogen and progestin with several actions on women’s health. The different pharmacological composition of EPs is responsible for different clinical effects. One of the most used low-dose EP associations is ethinylestradiol 20 mcg plus levonorgestrel 100 mcg in monophasic regimen (EE20/LNG100). This review summarizes clinical pharmacology, cycle control, and effects on lipid and glucose metabolism, coagulation, body weight/body composition, acne, and sexuality of EE20/LNG100. Overall, EE20/LNG100 combination is safe and well tolerated, and in several studies the incidence of adverse events in the treated group was comparable to that of the placebo group. Cycle control was effective and body weight/body composition did not vary among treated and untreated groups in most studies. The EE20/LNG100 combination shows mild or no effect on lipid and glucose metabolism. Lastly, EE20/LNG100 is associated with a low risk of venous thromboembolism (VTE). In conclusion, in the process of decision making for the individualization of EPs choice, EE20/LNG100 should be considered for its favorable clinical profile.

Effects on body weight and body composition of a low-dose oral estroprogestin containing ethinyl estradiol 20 μg plus levonorgestrel 100 μg

2007 ◽  
Vol 23 (11) ◽  
pp. 632-637 ◽  
Author(s):  
Stefano Lello ◽  
Giorgio Vittori ◽  
Anna Maria Paoletti ◽  
Roberto Sorge ◽  
Francesca Guardianelli ◽  
...  
Keyword(s):  
Body Composition ◽  
Body Weight ◽  
Low Dose ◽  
Ethinyl Estradiol ◽  
Dose Oral

scholarly journals Low Dose Leptin Administration Reverses Effects of Sustained Weight-Reduction on Energy Expenditure and Circulating Concentrations of Thyroid Hormones

2002 ◽  
Vol 87 (5) ◽  
pp. 2391-2394 ◽  
Author(s):  
Michael Rosenbaum ◽  
Ellen M. Murphy ◽  
Steven B. Heymsfield ◽  
Dwight E. Matthews ◽  
Rudolph L. Leibel
Keyword(s):  
Body Composition ◽  
Body Weight ◽  
Energy Expenditure ◽  
Thyroid Hormones ◽  
Low Dose ◽  
Total Energy Expenditure ◽  
Metabolic Phenotype ◽  
Time Points ◽  
Reduced Body ◽  
Reduced State

Maintenance of a reduced body weight is associated with decreased 24-hour energy expenditure, and decreased circulating concentrations of leptin and thyroid hormones. To determine whether these adaptive metabolic and endocrine changes are partly leptin-mediated, we measured body composition, aspects of energy expenditure, and circulating concentrations of leptin and thyroid hormones in 4 subjects at 3 time points: 1.) Usual body weight; 2.) While stable at 10% reduced body weight; and 3.) During a 5-week period at 10% reduced body weight while receiving twice per day leptin injections that restored 8 AM circulating leptin concentrations to those seen at usual body weight. During maintenance of a 10% reduced body weight, circulating T3, T4, and leptin concentrations were decreased. All of these endocrine changes were reversed by administration of “replacement” doses of leptin (r-metHuLeptin). Indirect calorimetry, and subtle changes in body composition associated with leptin administration, were used to calculate the net change in stored calories and in 24-hour energy expenditure. Total energy expenditure increased in all subjects during r-metHuLeptin administration. These data indicate that decrease leptin concentrations resulting from loss of fat mass account for some aspects of the endocrine/metabolic phenotype associated with the weight-reduced state.

scholarly journals Double-Blind, Randomized, Three-Armed, Placebo-Controlled, Clinical Investigation to Evaluate the Benefit and Tolerability of Two Dosages of IQP-AE-103 in Reducing Body Weight in Overweight and Moderately Obese Subjects

2019 ◽  
Vol 2019 ◽  
pp. 1-12 ◽  
Author(s):  
Ralf Uebelhack ◽  
Udo Bongartz ◽  
Stephanie Seibt ◽  
Gordana Bothe ◽  
Pee Win Chong ◽  
...  
Keyword(s):  
Weight Loss ◽  
Body Weight ◽  
Placebo Group ◽  
Body Fat ◽  
Dose Group ◽  
Low Dose ◽  
Clinical Investigation ◽  
Controlled Trial ◽  
High Dose ◽  
Double Blind

Objective. This study was performed to determine the efficacy and tolerability/safety of IQP-AE-103 on body weight reduction in overweight to moderately obese adults. Methods. A double-blind, randomized, placebo-controlled trial involved one hundred and eight subjects (BMI between 25 and 35 kg/m2) that were randomly assigned to either the low-dose or the high-dose IQP-AE-103 group, or the placebo group. Following a 2-week run-in period, subjects received two capsules of investigational product after three daily main meals for 12 weeks. Subjects were instructed to maintain a nutritionally balanced hypocaloric diet according to the individual’s energy requirement. Body weight, body fat, and waist and hip circumference were measured at baseline, and after 2, 4, 8, and 12 weeks. Subjects also rated their feelings of hunger and fullness using visual analogue scales, and food craving on a 5-point scale at the same time intervals. Blood samplings for safety laboratory parameters were taken before and at the end of the study. Results. After 12 weeks of intake, the high-dose IQP-AE-103 group had a significantly greater weight loss compared with the placebo (5.03 ± 2.50 kg vs. 0.98 ± 2.06 kg, respectively; p<0.001) and the low-dose group (3.01 ± 2.19 kg; p=0.001). The high-dose group experienced a decrease in body fat of 3.15 ± 2.41 kg compared with a decrease of 0.23 ± 2.74 kg for the placebo group (p<0.001). High-dose IQP-AE-103 also decreased the feeling of hunger in 66% subjects. A beneficial effect of IQP-AE-103 on the lipid metabolism was also demonstrated in the subgroup of subjects with baseline total cholesterol levels above 6.2 mmol/L. No side effects related to the intake of IQP-AE-103 were reported. Conclusions. These findings indicate that IQP-AE-103 could be an effective and safe weight loss intervention. This trial is registered with NCT03058367.

Effect of exercise training on insulin sensitivity and glucose metabolism in lean, obese, and diabetic men

1991 ◽  
Vol 71 (6) ◽  
pp. 2402-2411 ◽  
Author(s):  
K. R. Segal ◽  
A. Edano ◽  
A. Abalos ◽  
J. Albu ◽  
L. Blando ◽  
...  
Keyword(s):  
Body Composition ◽  
Body Weight ◽  
Insulin Sensitivity ◽  
Glucose Metabolism ◽  
Exercise Training ◽  
Cardiorespiratory Fitness ◽  
Insulin Action ◽  
Training Session ◽  
Hepatic Glucose ◽  
Glucose Output

To clarify the impact of vigorous physical training on in vivo insulin action and glucose metabolism independent of the intervening effects of concomitant changes in body weight and composition and residual effects of an acute exercise session, 10 lean, 10 obese, and 6 diet-controlled type II diabetic men trained for 12 wk on a cycle ergometer 4 h/wk at approximately 70% of maximal O2 uptake (VO2max) while body composition and weight were maintained by refeeding the energy expended in each training session. Before and 4–5 days after the last training session, euglycemic hyperinsulinemic (40 mU.m2.min-1) clamps were performed at a plasma glucose of 90 mg/dl, combined with indirect calorimetry. Total insulin-stimulated glucose disposal (M) was corrected for residual hepatic glucose output. Body weight, fat, and fat-free mass (FFM) did not change with training, but cardiorespiratory fitness increased by 27% in all groups. Before and after training, M was lower for the obese (5.33 +/- 0.39 mg.kg FFM-1.min-1 pretraining; 5.33 +/- 0.46 posttraining) than for the lean men (9.07 +/- 0.49 and 8.91 +/- 0.60 mg.kg FFM-1.min-1 for pretraining and posttraining, respectively) and lower for the diabetic (3.86 +/- 0.44 and 3.49 +/- 0.21) than for the obese men (P less than 0.001). Insulin sensitivity was not significantly altered by training in any group, but basal hepatic glucose production was reduced by 22% in the diabetic men. Thus, when intervening effects of the last exercise bout or body composition changes were controlled, exercise training per se leading to increased cardiorespiratory fitness had no independent impact on insulin action and did not improve the insulin resistance in obese or diabetic men.

scholarly journals Study on Ameliorative Effect of Febuxostat on Gout Induced Model in Broiler Chicks

2017 ◽  
Vol 13 (01) ◽  
Author(s):  
M. K. Patel ◽  
D. J. Dave ◽  
R. C. Rathod ◽  
B. P. Joshi ◽  
D. J. Ghodasara
Keyword(s):  
Body Weight ◽  
Low Dose ◽  
Body Weight Gain ◽  
Treated Group ◽  
Group Iv ◽  
Control Group ◽  
High Dose ◽  
Broiler Chicks ◽  
Ameliorative Effect ◽  
Group Ii

This work was conducted on six groups of day-old Cobb-400 broiler chicks to study the ameliorative effect of febuxostat on gout induced model. Clinical signs were noticed in birds of diclofenac control group II and low dose febuxostat treated group IV. During the study, 27.77% and 22.22% mortality were observed in diclofenac control group II and low dose febuxostat treated group IV, respectively. Febuxostat control group III and febuxostat (medium and high dose) treated groups V and VI had no mortality. Reduction in body weight gain and feed intake was observed in diclofenac control group II as compared to without treatment control group I at the end of every week during the experimental period of 21 days. Reduction in body weight gain and feed intake was observed in low dose febuxostat treated group IV as compared to control group at the end of 1st week. The average FCR was higher in diclofenac control group II (2.54) and low dose febuxostat treated group IV (2.14) as compared to control group (2.00). Kidney: body weight ratio was significantly high in diclofenac control group II as compared to control group at the end of experiment. Gross and microscopic lesions of visceral gout were mainly observed in chicks that died during the experiment from diclofenac control group II and low dose febuxostat treated group IV. The overall lesions showed that diclofenac was nephrotoxic and hepatotoxic in nature. Febuxostat at lower than the therapeutic dose did not prevent nephrotoxicity and hepatotoxicity caused by diclofenac leading to visceral gout. Febuxostat control III and febuxostat (medium and high dose) treated groups V and VI did not reveal any pathomorphological changes. Judicious use of febuxostat is safe in poultry birds between the limit of 4 mg/kg and 6 mg/kg

scholarly journals Contribution of Gestational Weight Gain on Maternal Glucose Metabolism in Women with GDM and Normal Glucose Tolerance

2020 ◽  
Author(s):  
Fernanda L Alvarado ◽  
Perrie O’Tierney-Ginn ◽  
Patrick Catalano
Keyword(s):  
Body Composition ◽  
Body Weight ◽  
Weight Gain ◽  
Insulin Sensitivity ◽  
Glucose Metabolism ◽  
Glucose Tolerance ◽  
Normal Glucose Tolerance ◽  
Gestational Weight ◽  
Normal Glucose ◽  
The Relationship

Abstract Context Efforts to decrease the risk of developing metabolic complications of pregnancy such as gestational diabetes (GDM) through lifestyle intervention (decreasing excessive gestational weight gain (GWG)) during pregnancy have met with limited success. Objective The purpose of this study was to determine the relationship between the longitudinal changes in weight/body composition and insulin sensitivity and response in women with normal glucose tolerance (NGT) and those who developed GDM. Design We conducted a secondary analysis of a prospective cohort developed before conception and again at 34-36 weeks gestation. Twenty-nine NGT and seventeen GDM women were evaluated for longitudinal changes in insulin sensitivity/response using the hyperinsulinemic-euglycemic clamp and an IV-glucose tolerance test. Body composition was estimated using hydrodensitometry. Both absolute (Δ) and relative change (%Δ) between these two time points were calculated. We performed simple and multiple linear regression analysis to assess the relationship between GWG and measures of glucose metabolism, i.e. insulin sensitivity and response. Results Based on the primary study design there was no significant difference in clinical characteristics between women with NGT and those developing GDM. Prior to pregnancy, women who developed GDM had lower insulin sensitivity levels (p=0.01) compared to NGT women. Absolute change and %Δ in insulin sensitivity/insulin response and body weight/body composition was not significantly different between NGT and GDM women. Changes in body weight contributed to only 9% of the Δ insulin sensitivity both in women developing GDM and NGT women. Conclusions These data suggest that other factors – such as maternal pre-pregnancy insulin sensitivity and placental derived factors affecting insulin sensitivity rather than maternal GWG account for the changes in glucose metabolism during human pregnancy.

Effect of empagliflozin versus placebo on body composition in patients with acute myocardial infarction and type 2 diabetes mellitus: subgroup analysis of the EMBODY trial

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
Y Hoshika ◽  
Y Kubota ◽  
K Mozawa ◽  
K Yodogawa ◽  
Y Iwasaki ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Heart Failure ◽  
Type 2 Diabetes ◽  
Acute Myocardial Infarction ◽  
Body Composition ◽  
Body Weight ◽  
Placebo Group ◽  
Sglt2 Inhibitor ◽  
Funding Source

Abstract Background Prevention of heart failure is one of the most important challenges after acute myocardial infarction (AMI). The development of heart failure is closely associated with fluid balance which can be evaluated by the measurement of body composition such as total body water (TBW), extracellular water (ECW), and intracellular water (ICW). This subgroup analysis of the EMBODY trial was designed to determine whether the Sodium–glucose cotransporter 2 (SGLT2) inhibitor affect fluid balance and improve heart failure in patients after AMI. Methods The EMBODY trial was a prospective, multicenter, randomized, double-blind, placebo-controlled trial in patients with AMI and type 2 diabetes in Japan. A total of 105 patients were randomized (1:1) to receive once-daily 10 mg empagliflozin, an SGLT2 inhibitor or placebo 2 weeks after the onset of AMI. In this subanalysis, we investigated the time-course of body composition measured by a bioelectrical impedance analyzer “InBody®”. The primary endpoints were changes in every particular parameter of body composition at week 0, 4, 12, and 24. Secondary endpoints were changes in blood pressure (BP), body weight and N-terminal pro b-type natriuretic peptide (NT-proBNP). Results Overall, 55 patients were included in the full analysis set (67.2±10.0 years, male 78.2%, and n=30 in empagliflozin group and 25 in placebo group). Baseline characteristics were not significantly different between the two groups. The change between at baseline and 24 weeks in TBW was −0.44 L (P=0.19) in the empagliflozin group and +1.14 L (P=0.0002) in the placebo group, adjusted difference −1.58 L, 95% confidence interval (CI) −2.46 to −0.70 L (P=0.0006). The empagliflozin group showed significant decreases in the body weight, ECW, ICW and systolic BP compared with the placebo group (−2.2 kg vs, +0.01 kg, P=0.004, −0.21 L vs, +0.40 L, P=0.001, −0.23 L vs, +0.74 L, P=0.0007, and −11.0 mmHg vs, +5.0 mmHg, P&lt;0.0001, respectively). On the other hand, NT-Pro BNP levels significantly decreased in the empagliflozin group and placebo group (1028.7 pg/mL to 370.3 pg/ml, p=0.0001 and 1270.6 pg/mL to 673.7 pg/ml, p=0.006, respectively). In the multiple regression analysis of the change in TBW and ICW for the empagliflozin group, systolic BP was identified as a significant factor (P=0.001, and 0.003, respectively). In stratified analysis of BMI 25 kg/m2 or more, the empagliflozin group showed significant decreases in body weight, TBW, ECW and ICW compared with the placebo group, but not below BMI 25 kg/m2 group. Conclusion Empagliflozin reduced not only body weight, but also TBW, ECW and ICW. Interestingly, this tendency was remarkable at BMI 25 or more. This study suggested that early SGLT2 inhibitor administration in obesity patients with AMI and DM might be effective to reduce body weight and TBW. Funding Acknowledgement Type of funding source: Private grant(s) and/or Sponsorship. Main funding source(s): Boehringer Ingelheim

Abstract P364: Preliminary Study of the Effects of Coffee Mannooligosaccharides Supplementation on Lipid Profile.

Circulation ◽  
2012 ◽  
Vol 125 (suppl_10) ◽  
Author(s):  
Stacy Tsai ◽  
Arindam RoyChoudhury ◽  
Majella O'Keeffe ◽  
Marie-Pierre St-Onge
Keyword(s):  
Risk Factors ◽  
Weight Loss ◽  
Body Composition ◽  
Body Weight ◽  
Regression Analysis ◽  
Placebo Group ◽  
Lipid Profile ◽  
Metabolic Risk ◽  
Sample Analysis ◽  
Weight Loss Study

Introduction: Coffee-derived mannooligosaccharides (MOS) have been shown to have prebiotic activity and improve body composition in overweight individuals. However, the effects of MOS consumption on metabolic risk factors have not been studied. The overall goal of this study was to determine the effects of MOS consumption on body composition and metabolic risk factors. Hypothesis: We hypothesized that the intake of MOS would result in improvements in lipid profile after controlling for changes in body weight. Design: Two separate randomized, placebo-controlled studies, weight maintenance or weight loss, were conducted to assess the role of MOS for weight management. For each study, participants consumed MOS (4 g/d) or Placebo coffee beverages for 12 wk. Fasting blood samples were taken at baseline and endpoint of both studies. Complete datasets were available for 31 participants who consumed MOS (13 in weight loss study) and 32 (17 in weight loss study) who consumed the Placebo beverage. Regression analysis wasperformed including body weight, age, sex, time and time x beverage interaction as covariates to determine the effects of MOS supplementation on serum lipid levels. The regression analysis was additionally performed on a sub-sample with mildly elevated low-density lipoprotein cholesterol (LDL-C &#8805; 130 mg/dL). Results: Participants had a mean age (SEM) and body mass index of 45.0 ± 11.3 y and 30.2 ± 2.6 kg/m2. In the whole sample analysis, there was no time x beverage interaction for any of the lipid parameters (all P> 0.05). Total cholesterol (TC) changed by -2.5 ± 15.8% in the MOS group and by -1.0 ± 11.3% in the Placebo group. LDL-C changed by -2.0 ± 30.1% in the MOS group and by -2.2 ± 21.4% in the Placebo group. In the sub-sample analysis (MOS n = 12, Placebo n = 18), there was no time x beverage interaction on TC (MOS-17.1 ± 9.1% vs Placebo -5.6±10.1%, P = 0.197). Similar results were observed for LDL-C (MOS -25.6 ± 14.4% vs Placebo -8.4 ± 17.3%, P = 0.164) and triglycerides (MOS -8.5 ± 100.2% vs Placebo -3.4± 25.9%, P = 0.358). Conclusions: Our data provide preliminary information on the effects of MOS supplementation on cardiovascular risk profile. Although not significant, our results suggest that MOS consumption may be useful to improve lipid profile in individuals with elevated LDL-C but our sample size was inadequate to affirm this with confidence. Future studies should be specifically designed to determine the effects of MOS supplementation on lipid profiles of at risk individuals.

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