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Effects of exenatide on urinary albumin in overweight/obese patients with T2DM: a randomized clinical trial.

ABSTRACT: In this study, we investigated the effect of exenatide (EXE), a glucagon-like peptide (GLP)-1 receptor agonist, on kidney function, obesity indices, and glucose control in overweight/obese patients with type 2 diabetes mellitus (T2DM). A total of 159 overweight/obese patients with T2DM were randomized to the EXE group or insulin glargine (GLAR) control group for a total treatment period of 24 weeks. EXE intervention significantly reduced the urine albumin concentration (UAC) at week 12 and 24 endpoints (P < 0.001 at week 12 and 24). The levels of the anthropometric, glucose and lipid parameters (TG and HDL-c), and inflammation biomarkers (CRP and TNF-α) in the EXE group were improved at 12 weeks or 24 weeks, respectively. Meanwhile, a comparison between two groups showed significant changes in anthropometric parameters, glucose parameters, lipid parameters (TG and HDL-c), and Inflammation biomarkers (CRP, IL-6, and TNF-α). Serum fibroblast growth factor 21 (FGF21) was increased in the EXE group (P = 0.005) at week 24, and the change was significantly improved compared with GLAR group (P = 0.003). Correlation network analysis showed that FGF21 had a more central role in improving metabolism in the EXE group, and the change of FGF 21 was significantly negatively correlated with UAC at week 12 and week 24, respectively (r = - 0.297, P = 0.010; r = - 0.294, P = 0.012). Our results showed that EXE could help patients improve UAC, glycemic levels, and inflammatory biomarkers after a follow-up period of 24 weeks intervention. These EXE effects may be partly mediated by FGF 21, indicating that EXE is an effective and safe way to control albuminuria in overweight/obese patients with T2DM.

SUBMITTER: Kang C

PROVIDER: S-EPMC8501012 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:INTRODUCTION:Increasing the frequency of blood glucose monitoring aids the evaluation of glycemic variability and blood glucose control by antidiabetic drugs. It remains unclear, however, whether GLP-1 receptor agonists or basal insulin has a better effect on glycemic variability in type 2 diabetes mellitus (T2DM) patients who are inadequately controlled by metformin. We used a continuous glucose monitoring system (CGMS) to compare patients on a GLP-1 receptor agonist with patients on basal insulin in terms of glycemic variability. METHODS:This prospective randomized study assigned T2DM patients treated with metformin (N = 39) to either exenatide treatment or insulin glargine treatment for 16 weeks. Glycemic variability was assessed using a CGMS; hemoglobin A1c (HbA1c), β-cell function, weight, body mass index (BMI), and waist circumference were also evaluated. RESULTS:Mean blood glucose level, continuous overlapping net glycemic action, mean amplitude of glycemic excursions, percentage of the time that the blood glucose value was > 10.0 mmol/L, and highest blood glucose level (P < 0.01-0.05) significantly decreased in both groups. Standard deviation of the mean glucose value, largest amplitude of glycemic excursions, and waist circumference significantly decreased for those treated with exenatide (P < 0.05), while no changes were observed with insulin glargine treatment. Percentage of the time that the blood glucose value was > 7.8 mmol/L decreased after insulin glargine use (P < 0.05) but not with the exenatide intervention. Similar decreases in fasting blood glucose and HbA1c and increases in the 1/homeostasis model assessment of insulin resistance, disposition index 30, and disposition index 120 were observed in both groups (P < 0.01-0.05). Reductions in weight and BMI were greater with exenatide than with insulin glargine treatment (P < 0.05). CONCLUSIONS:In overweight and obese patients with T2DM inadequately controlled by metformin, exenatide and insulin glargine have similar efficacies in terms of glycemic variability, HbA1c alleviation, and β-cell function, but exenatide has a greater effect on body weight and BMI.

Project description:Many current treatment options for managing overweight and obesity consist of rather strict diet and exercise regimes that are difficult to implement as a lifelong routine. Therefore, alternative initiatives such as mindful eating and pleasure-oriented physical activity with more focus on implementation and enjoyment are needed to reverse the obesity epidemic. Mindful eating is an approach focusing on inner hunger and satiety signals. YogaDance is a novel exercise approach combining elements of yoga and dance. This study was a randomized controlled trial investigating the individual and combined effects of mindful eating and YogaDance. Participants were healthy, inactive women with overweight or obesity (body mass index ≥ 25 kg/m2 and/or waist circumference ≥ 80 cm) who were randomized to one of four groups for 8 weeks: mindful eating alone, YogaDance alone, the combination of mindful eating and YogaDance, or control. Fat mass was the primary outcome and secondary outcomes included body weight, waist circumference, and other physiological, behavioral, and quality-of-life outcomes. Sixty-one women were included in the study and randomized to mindful eating and YogaDance combined, YogaDance, mindful eating, or control. Fat mass was reduced by 1.3 kg (95% CI [-10.0, 7.3] kg; p = 0.77), 3.0 kg (95% CI [-11.1, 5.1] kg; p = 0.48), and 1.8 kg (95% CI [-10.1, 6.6] kg; p = 0.69) for the mindful eating, YogaDance, and combined mindful eating and YogaDance interventions, respectively, compared to the control, with corresponding effect sizes of 0.15, 0.34, and 0.21. In complete-case analyses, fat percent and waist circumference were reduced whereas mental quality of life and eating behavior were improved for mindful eating and mindful eating and YogaDance combined compared to the control. In conclusion, the study found modest benefits of an 8-week combination of mindful eating and YogaDance, corroborating findings in previous studies on mindful eating, yoga, and dance. However, the study had several limitations that should be taken into consideration, including low power due to a large drop-out as well as low to moderate training load and compliance. The trial was retrospectively registered (ISRCTN87234794).

Project description:ObjectiveAs there is significant heterogeneity in the weight loss response to pharmacotherapy, one of the most important clinical questions in obesity medicine is how to predict an individual's response to pharmacotherapy. The present study examines patterns of weight loss among overweight and obese women who demonstrated early robust response to twice daily exenatide treatment compared to those treated with hypocaloric diet and matched placebo injections.MethodsWe randomized 182 women (BMI 25-48 kg/m2) to treatment with exenatide alone or matched placebo injections plus hypocaloric diet. In both treatment groups, women who demonstrated ≥ 5% weight loss at 12 weeks were characterized as high responders and those who lost ≥10% of body weight were classified as super responders. Our primary outcome was long-term change in body weight among early high responders to either treatment. An exploratory metabolomic analysis was also performed.ResultsWe observed individual variability in weight loss with both exenatide and hypocaloric diet plus placebo injections. There was a trend toward a higher percentage of subjects who achieved ≥ 5% weight loss with exenatide compared to diet (56% of those treated with exenatide, 76% of those treated with diet, p = 0.05) but no significant difference in those who achieved ≥ 10% weight loss (23% of individuals treated with exenatide and 36% of those treated with diet, p = 0.55). In both treatment groups, higher weight loss at 3 months of treatment predicted super responder status (diet p=0.0098, exenatide p=0.0080). Both treatment groups also demonstrated similar peak weight loss during the study period. We observed lower cysteine concentrations in the exenatide responder group (0.81 vs 0.48 p < 0.0001) and a trend toward higher levels of serotonin, aminoisobutyric acid, anandamide, and sarcosine in the exenatide super responder group.ConclusionIn a population of early high responders, longer term weight loss with exenatide treatment is similar to that achieved with a hypocaloric diet.Clinical trial registrationwww.clinicaltrialsgov, identifier NCT01590433.

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Effects of exenatide on urinary albumin in overweight/obese patients with T2DM: a randomized clinical trial.

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