scholarly journals Effects of once-weekly semaglutide vs once-daily canagliflozin on body composition in type 2 diabetes: a substudy of the SUSTAIN 8 randomised controlled clinical trial

Diabetologia ◽  
2020 ◽  
Vol 63 (3) ◽  
pp. 473-485 ◽  
Author(s):  
Rory J. McCrimmon ◽  
Andrei-Mircea Catarig ◽  
Juan P. Frias ◽  
Nanna L. Lausvig ◽  
Carel W. le Roux ◽  
...  

Abstract Aims/hypothesis Intra-abdominal or visceral obesity is associated with insulin resistance and an increased risk for cardiovascular disease. This study aimed to compare the effects of semaglutide 1.0 mg and canagliflozin 300 mg on body composition in a subset of participants from the SUSTAIN 8 Phase IIIB, randomised double-blind trial who underwent whole-body dual-energy x-ray absorptiometry (DXA) scanning. Methods Adults (age ≥18 years) with type 2 diabetes, HbA1c 53–91 mmol/mol (7.0–10.5%), on a stable daily dose of metformin (≥1500 mg or maximum tolerated dose) and with an eGFR ≥60 ml min−1 [1.73 m]−2 were randomised 1:1 to semaglutide 1.0 mg once weekly and canagliflozin placebo once daily, or canagliflozin 300 mg once daily and semaglutide placebo once weekly. Body composition was assessed using whole-body DXA scans. The study participants and investigator remained blinded throughout the trial, and quality of DXA scans was evaluated in a blinded manner. Change from baseline to week 52 in total fat mass (kg) was the confirmatory efficacy endpoint. Results A subset of 178 participants (semaglutide, n = 88; canagliflozin, n = 90) underwent DXA scanning at screening and were randomised into the substudy. Of these, 114 (semaglutide, n = 53; canagliflozin, n = 61) participants had observed end-of-treatment data included in the confirmatory efficacy analysis. Of the 178 participants in the substudy, numerical improvements in body composition (including fat mass, lean mass and visceral fat mass) were observed after 52 weeks with both treatments. Total fat mass (baseline 33.2 kg) was reduced by 3.4 kg and 2.6 kg with semaglutide and canagliflozin, respectively (estimated treatment difference: –0.79 [95% CI −2.10, 0.51]). Although total lean mass (baseline 51.3 kg) was also reduced by 2.3 kg and 1.5 kg with semaglutide and canagliflozin, respectively (estimated treatment difference: −0.78 [−1.61, 0.04]), the proportion of lean mass (baseline 59.4%) increased by 1.2%- and 1.1%-point, respectively (estimated treatment difference 0.14 [−0.89, 1.17]). Changes in visceral fat mass and overall changes in body composition (assessed by the fat to lean mass ratio) were comparable between the two treatment groups. Conclusions/interpretation In individuals with uncontrolled type 2 diabetes on stable-dose metformin therapy, the changes in body composition with semaglutide and canagliflozin were not significantly different. Although numerical improvements in body composition were observed following treatment in both treatment arms, the specific impact of both treatments on body composition in the absence of a placebo arm is speculative at this stage. Trial registration ClinicalTrials.gov NCT03136484. Funding This trial was supported by Novo Nordisk A/S, Denmark.

Nutrients ◽  
2020 ◽  
Vol 12 (1) ◽  
pp. 179 ◽  
Author(s):  
Nivedita Pavithran ◽  
Harish Kumar ◽  
Arun Somasekharan Menon ◽  
Gopala Krishna Pillai ◽  
Karimassery Ramaiyer Sundaram ◽  
...  

Background: There has been no previous study that has investigated the effect of a low glycemic index (LGI) diet with local recipes of South Indian cuisine on the body fat composition using dual-energy X-ray absorptiometry (DXA). Truncal obesity has been associated with the risk of metabolic disorders and cardiovascular diseases. Aim: The aim of this study was to examine the effect of a low GI diet on glycemic control and body composition in people with type 2 diabetes in South India. Method: This was a prospective and randomized controlled study that was conducted over a period of 24 weeks. A total of 40 participants were recruited from the Department of Endocrinology and Diabetes Outpatient in Kerala, South India. All the patients had type 2 diabetes and were randomly assigned and given advice and instructions to follow either a low GI diet plan (n = 18) or their usual diet, which served as control (n = 18). The advice was reinforced throughout the study period. Dietary compliance was evaluated based on a 24 h dietary recall at weeks 3, 11, 12, 18, 23, and 24. The age of the subjects ranged from 35 to 65 years. Anthropometric, body composition, and cardio-metabolic parameters were measured according to standard procedures. T-tests were conducted to compare differences between intervention and control groups and the Pearson correlation coefficient was used to evaluate associations between the variables. Results: There were significant reductions (p < 0.05) in the low GI diet compared to the control group with respect to weight, body mass index (BMI), and triceps skinfold thickness. Similarly, significant reductions were observed in the low GI diet group with respect to region, total fat, android, and gynoid fat mass and the differences between the groups were significant at p < 0.05. There was also a positive correlation between BMI and android fat mass (r = 0.745), total fat mass (r = 0.661), total truncal mass (r = 0.821), and truncal fat (r = 0.707). There was a significant reduction in glycated hemoglobin in the low GI diet group compared to the control group at p < 0.05. Conclusion: This study has demonstrated that there was a significant reduction (p < 0.05) of truncal obesity and glycated hemoglobin in patients with type 2 diabetes on a local diet of South Indian cuisine with low GI compared with the control.


2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 1568-1568
Author(s):  
Pritesh S Karia ◽  
Corinne Joshu ◽  
Kala Visvanathan

1568 Background: Prior studies suggest that bilateral oophorectomy (BO), a common cancer prevention strategy, may be associated with adiposity. However, the impact of BO on lean mass, a potential marker of healthy aging, and whole-body composition is not known. Declines in lean mass have been linked to physical disability and mortality. We examined the association between BO and total and regional distribution of fat and lean mass in a cross-sectional study. Methods: The study population included women 35-70 years who underwent dual-energy x-ray absorptiometry (DXA) scans at enrollment as part of the National Health and Nutrition Examination Survey 1999-2006 (N = 3,764). Multinomial logistic regression models were used to examine the relationship between prior BO and tertiles of fat and lean mass. Models were adjusted for age, race, education, BMI at age 25, physical activity, smoking, alcohol use, parity, oral contraceptive use and hormone replacement therapy use. Results: Women with prior BO < 45 years (n = 346) had 2.9-times higher odds than women without BO (n = 3,212) of being in the highest compared to the lowest tertile of total fat mass (OR, 2.91; 95% CI, 1.93-4.38) and 2.7-times higher odds of being in the lowest compared to the highest tertile of total lean mass (OR, 2.67; 95% CI, 1.81-3.95). Results were similar when stratified by age at enrollment ( < 45, 45-54, and ≥55). Similarly, among women with normal BMI at enrollment, those with prior BO < 45 years (n = 74) had higher odds of being in the highest tertile of total fat mass (OR, 9.88, 95% CI, 2.21-44.00) and the lowest tertile of total lean mass (OR, 10.09; 95% CI, 2.72-37.46). These differences in body composition were most pronounced in the trunk region. No difference was observed in women with BO ≥45 years compared to women without BO. Conclusions: Women with a history of early BO experience significant changes in body composition, including increased fat mass and decreased lean mass, even while maintaining a normal BMI. If validated in future prospective studies, our results suggest that a comprehensive evaluation of body composition may be warranted in young women who undergo BO.


2020 ◽  
Vol 79 (OCE2) ◽  
Author(s):  
Maria Nikolova ◽  
Alexander Penkov

AbstractIntroduction:Obesity has been linked with vitamin D deficiency in a number of cross-sectional studies, reviews and meta-analyses. To assess the correlations of plasma 25(OH) vitamin D levels with indices of body composition examined by DXA with an emphasis on lean and bone mass as well as on indices such as android/gynoid fat, appendicular lean mass (ALM) and appendicular lean mass index (ALMI), fat-mass indexes (FMI), fat-free mass indexes (FFMI) and the ALM-to-BMI index.Materials and Methods:62 adult subjects consented to participate – 27 men (43.5 %) and 35 women (56.5 %). Their mean age was 45.3 ± 9.5 years. Fan-beam dual-energy X-ray (DXA) body composition analysis was performed on a Lunar Prodigy Pro bone densitometer with software version 12.30. Vitamin D was measured by electro-hemi-luminescent detection as 25(OH)D Total (ECLIA, Elecsys 2010 analyzer, Roche Diagnostics). Statistical analyses were done using the SPSS 23.0 statistical package.Results:The serum 25(OH)D level was correlated significantly only to the whole body bone mineral content, the appendicular lean mass index (ALMI) and the ALM-to-BMI index, underlining a predominant role for lean and fat-free mass. Vitamin D showed a very weak correlation to % Body Fat and the Fat Mass Index (FMI) in men only. Moreover, the multiple regression equation including the associated parameters could explain only 7 % of the variation in the serum 25(OH)D levels.Discussion:Our conclusion was, that there are differences in the associations of the vitamin D levels with the different body composition indices, but these associations are generally very weak and therefore – negligible.


2008 ◽  
Vol 93 (11) ◽  
pp. 4486-4493 ◽  
Author(s):  
Anders Rinnov Nielsen ◽  
Pernille Hojman ◽  
Christian Erikstrup ◽  
Christian Philip Fischer ◽  
Peter Plomgaard ◽  
...  

Objective: IL-15 decreases lipid deposition in preadipocytes and decreases the mass of white adipose tissue in rats, indicating that IL-15 may take part in regulating this tissue. IL-15 is expressed in human skeletal muscle and skeletal muscle may be a source of plasma IL-15 and in this way regulate adipose tissue mass. Design: The relation between skeletal muscle IL-15 mRNA expression, plasma IL-15, and adipose tissue mass was studied in 199 humans divided into four groups on the basis of obesity and type 2 diabetes. Furthermore, using a DNA electrotransfer model, we assessed the effect of IL-15 overexpression in skeletal muscle of mice. Results: In humans, multiple regression analysis showed a negative association between plasma IL-15 and total fat mass (P &lt; 0.05), trunk fat mass (P &lt; 0.01), and percent fat mass (P &lt; 0.05), independent of type 2 diabetes. Negative associations were also found between muscle IL-15 mRNA and obesity parameters. IL-15 overexpression in skeletal muscle of mice reduced trunk fat mass but not sc fat mass. Conclusions: Our results indicate that IL-15 may be a regulator of trunk fat mass.


2019 ◽  
Vol 3 (Supplement_1) ◽  
Author(s):  
Maryam Razaghi ◽  
Catherine Vanstone ◽  
Olusola Sotunde ◽  
Nathalie Gharibeh ◽  
Sarah Kimmins ◽  
...  

Abstract Objectives Vitamin D status is positively associated with lean mass phenotype in healthy infants born with sufficient vitamin D stores. The objective is to test whether rapid correction of low neonatal vitamin D status improves body composition (lean mass and fat mass) at 6 mo of age. Methods In a double-blinded randomized parallel group controlled trial (NCT02563015), healthy term neonates of appropriate weight for gestational age were recruited from Montreal. Capillary blood samples were collected 24–36 h post natally for measurement of serum 25-hydroxyvitamin D [25(OH)D] (Liaison, Diasorin Inc.). Infants with serum 25(OH)D < 50 nmol/L (n = 87) were randomized to receive 400 or 1000 IU/d until 6 mo of age. Those with 25(OH)D ≥ 50 nmol/L (n = 31) were recruited as a reference group, and received 400 IU/d. Anthropometry, lean mass and fat mass (dual-energy x-ray absorptiometry) were measured at baseline, 3 and 6 mo. Skin color was measured using a spectrophotometer. Differences between treatments and reference groups were tested using mixed model and repeated measures ANOVA accounting for the effects of sex, season of birth, skin color and gestational age (GA). Results Neonates (67 males, 51 females) were 39.6 ± 1wk GA and 3387 ± 371 g at birth. There were no differences between groups in lean mass or fat mass at baseline; nor in weight or length at any time-point. Combined treatment groups, had lower serum 25(OH)D concentrations at birth compared to the reference group (33 ± 11 vs. 69 ± 13 nmol/L, P < 0.0001). However, at 6 mo of age, serum 25(OH)D concentration was higher in the group receiving 1000 IU/d (n = 34), in comparison to the group receiving 400 IU/d (n = 29), and the reference (n = 19) group (125.0 ± 34.0, 82.2 ± 21.5 vs. reference 85.4 ± 32.1 nmol/L, P < 0.0001). Whole body lean mass was significantly different among groups (5071.3 ± 750.0, 4944.1 ± 616.3 and 5166.0 ± 645.4 g, respectively, P = 0.03), with infants in the treatment group provided a 400 IU/d supplement having a lower lean mass by 6 mo of age compared to the 1000 IU/d group. Fat mass was not different among groups following post-hoc testing (2967.0 ± 929.0 and 2962.0 ± 952.0, 2742.0 ± 754.0 g, P = 0.16). Conclusions Higher dosage supplementation of vitamin D rapidly improved vitamin D status and supported a leaner body phenotype in infancy. Funding Sources Canadian Institutes of Health Research.


Author(s):  
Jorge Pérez-Gómez ◽  
José Carmelo Adsuar ◽  
Miguel Ángel García-Gordillo ◽  
Pilar Muñoz ◽  
Lidio Romo ◽  
...  

(1) Background: Regucalcin or senescence marker protein 30 (SMP30) is a Ca2+ binding protein discovered in 1978 with multiple functions reported in the literature. However, the impact of exercise training on SMP30 in humans has not been analyzed. Aging is associated with many detrimental physiological changes that affect body composition, functional capacity, and balance. The present study aims to investigate the effects of whole body vibration (WBV) in postmenopausal women. (2) Methods: A total of 13 women (aged 54.3 ± 3.4 years) participated in the study. SMP30, body composition (fat mass, lean mass, and bone mass) and physical fitness (balance, time up and go (TUG) and 6-min walk test (6MWT)) were measured before and after the 12 weeks of WBV training. (3) Results: The WBV training program elicited a significant increase in SPM30 measured in plasma (27.7%, p = 0.004) and also in 6MWT (12.5%, p < 0.001). The WBV training also significantly reduced SPM30 measured in platelets (38.7%, p = 0.014), TUG (23.1%, p < 0.001) and total body fat mass (4.4%, p = 0.02). (4) Conclusions: There were no significant differences in balance, lean mass or bone mass. The present study suggests that 12 weeks of WBV has the potential to improve SPM30, fat mass, TUG and 6MWT in postmenopausal women.


2011 ◽  
Vol 74 (5) ◽  
pp. 565-571 ◽  
Author(s):  
Kendall F. Moseley ◽  
Devon A. Dobrosielski ◽  
Kerry J. Stewart ◽  
Suzanne M. Jan De Beur ◽  
Deborah E. Sellmeyer

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Bum Ju Lee ◽  
Mi Hong Yim

AbstractWhether anthropometric or body composition indices are better indicators of metabolic risk remains unclear. The objectives of this study were to compare the association of metabolic risk factors with anthropometric and body composition indices and to identify the better indicators for risk factors in a large-scale Korean population. In this cross-sectional study, the associations of body mass index (BMI), waist circumference (WC), and waist-to-height ratio (WHtR) as anthropometric indices and trunk fat mass (TFM), percent trunk fat mass (%TFM), whole-body total fat mass (WBTFM), and percent whole-body total fat mass (%WBTFM) as body composition indices with metabolic risk factors were compared by complex-samples multiple logistic regression models based on complex-sample survey data. In men, WHtR, BMI, and TFM were similarly associated with hypertension. Diabetes, hyperlipidemia, and hypo-high-density lipoprotein (HDL) cholesterolemia tended to be more strongly associated with WHtR and WC than body composition indices. Hypertriglyceridemia and hypercholesterolemia were more strongly associated with WHtR and %TFM than other indices. In women, hypertension tended to be more strongly associated with WHtR than other indices. TFM, %TFM, and WHtR were similarly associated with hyperlipidemia. Diabetes and hypo-HDL cholesterolemia were more strongly associated with WHtR and WC than body composition indices. Hypertriglyceridemia and hypercholesterolemia were more strongly associated with WHtR and %TFM than other indices. Among six metabolic risk factors, the validity and utility of the anthropometric indices in identifying risk factors tended to be similar to or better than those of the body composition indices, except for hypertension and hypercholesterolemia in men and hyperlipidemia and hypercholesterolemia in women.


2020 ◽  
Vol 4 (Supplement_2) ◽  
pp. 1627-1627
Author(s):  
Rosemary DeLuccia ◽  
May Cheung ◽  
Asma Altasan ◽  
Sumer Al-Ani ◽  
Rushali Parekh ◽  
...  

Abstract Objectives The objectives of this study were to determine if body composition and nutrient status are dependent on serumosteocalcin concentrations in healthy adults. Methods Adults 20 to 70 years of age completed fasting blood sampling to measure serum ionized calcium concentrations, serum ionized magnesium concentrations, and serum total osteocalcin concentrations. Dual Energy X-Ray Absorptiometry was also completed to measure body composition variables including body mass index (BMI), total fat mass, total fat freemass, total lean mass, android fat, gynoid fat, trunk fat, and visceral adipose tissue. Results A sample of 60 women and 78 men with a median age of 33.0 (21.0) years were categorized into two groups accordingto the median osteocalcin concentration measured: low osteocalcin (12.11 ± 2.72 ng/mL), and high osteocalcin (26.80 ± 9.72 ng/mL). Means, standard deviations, medians and interquartile ranges were calculated and independent t-tests, and Mann Whitney U tests were conducted to determine differences between groups in body composition variables. Total fat mass, total fat percentage, android fat, trunk fat, and trunk fat percentage were all significantly higher, and totalfat free mass, fat free mass percentage, total lean mass, lean mass percentage, serum ionized calcium concentrations, and serum ionized magnesium concentrations were all significantly lower (P &lt; 0.05) in the low osteocalcin groupcompared to the high osteocalcin group. There were no differences (P &gt;0.05) between groups in weight, gynoid fat, visceral adiposity tissue, or visceral adiposity tissue percentage. Conclusions The results of this study provide preliminary evidence that serum osteocalcin concentrations can predict bodycomposition. Interventional studies should consider methods to alter osteocalcin concentrations through vitamin ormineral supplementation as a means to improve body composition in adults. Funding Sources American Heart Association; Drexel University.


Sign in / Sign up

Export Citation Format

Share Document