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Short term monotherapy with GLP-1 receptor agonist liraglutide or PDE 4 inhibitor roflumilast is superior to metformin in weight loss in obese PCOS women: a pilot randomized study.

ABSTRACT: To evaluate whether liraglutide or roflumilast significantly affects body weight when compared to metformin in obese women with PCOS.A 12-week prospective randomized open-label study was conducted with 45 obese women with PCOS diagnosed by the ASRM-ESHRE Rotterdam criteria. They were randomized to metformin (MET) 1000 mg BID or liraglutide (LIRA) 1.2 mg QD s.c. or roflumilast (ROF) 500 mcg QD. The primary outcome was change in measures of obesity.Forty-one patients (aged 30.7?±?7.9 years, BMI 38.6?±?6.0 kg/m2, mean?±?SD) completed the study. Subjects treated with LIRA lost on average 3.1?±?3.5 kg (p?=?0.006), on ROF 2.1?±?2.0 kg (p?=?0.002) vs. 0.2?±?1.83 kg in MET group. BMI decreased for 1.1?±?1.26 kg/m2 in LIRA (p?=?0.006), for 0.8?±?0.99 kg/m2 in ROF (p?=?0.001) vs. 0.1?±?0.67 kg/m2 in MET. LIRA was superior to MET in reducing weight (p?=?0.022), BMI (p?=?0.020), waist circumference (p?=?0.007). LIRA also resulted in decrease in VAT area (p?=?0.015) and more favorable dynamics in glucose homeostasis during OGTT. ROF resulted in reduction of waist circumference (p?=?0.023). In addition, ROF led to testosterone reduction (p?=?0.05) and increase in menstrual frequencies (p?=?0.009) when compared to baseline.Short-term monotherapy with liraglutide or roflumilast was associated with significant weight loss in obese PCOS. Liraglutide was superior to metformin, whereas roflumilast resulted in greater, yet not statistically significant, mean weight loss when compared to metformin. Reduction of body weight with liraglutide resulted in improvement of body composition.ClinicalTrials.gov NCT02187250 .

SUBMITTER: Jensterle M

PROVIDER: S-EPMC4506413 | biostudies-literature | 2015 Jun

REPOSITORIES: biostudies-literature

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Short term monotherapy with GLP-1 receptor agonist liraglutide or PDE 4 inhibitor roflumilast is superior to metformin in weight loss in obese PCOS women: a pilot randomized study.

Jensterle Mojca M Salamun Vesna V Kocjan Tomaz T Vrtacnik Bokal Eda E Janez Andrej A

Journal of ovarian research 20150602

<h4>Objective</h4>To evaluate whether liraglutide or roflumilast significantly affects body weight when compared to metformin in obese women with PCOS.<h4>Design/main outcome measure</h4>A 12-week prospective randomized open-label study was conducted with 45 obese women with PCOS diagnosed by the ASRM-ESHRE Rotterdam criteria. They were randomized to metformin (MET) 1000 mg BID or liraglutide (LIRA) 1.2 mg QD s.c. or roflumilast (ROF) 500 mcg QD. The primary outcome was change in measures of obe ...[more]

PMID: 26032655

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Project description:B6.Cg-Lep ob/ob mice females were surgically implanted in an age of 10-12 weeks with Alzet osmotic mini pumps (model 1002, 0,25l/h, Cupertino, CA, USA) in two groups of ten mice each to perform continuous subcutaneous infusions of Dulbecco's phosphate buffered saline (vehicle; n = 8) or GLP-1 (GLP-1; n = 9) agonist Liraglutide (Victoza, batch# CS6C214, Novo Nordisk A/S, Bagsvaerd, Denmark) to investigate the effects of the respective treatment on peri-gonadal epididymal white adipose tissue gene expression. Vehicle or Liraglutide at a dose of 600 g/kg/d were continuously infused (at a dose of 600 g/kg/d) over a 14 days period. On the morning after the osmotic mini pump reservoirs liquid content should have been consumed mice were dissected to remove the peri-gonadal epididymal fat pad for white adipose tissue gene expression analysis. At least 220 mg of white adipose tissue was quickly removed, shock-frozen in liquid nitrogen and thereafter stored at -80C for mRNA extraction. To perform RNA-Seq analysis, samples were single-end sequenced at a depth of 75 80M reads per sample with a read-length of 51 bp using an Illumina Hiseq2500. Raw sequencing files were quality controlled with FastQC. Alignment and trimming of reads was performed using the OSA algorithm against the mouse reference genome b38.1 with RefSeq as the gene model as implemented in OmicSoft ArraySuite software, version 8. RNA transcripts were quantified using RSEM methods as implemented in Arraystudio counting count the read fragments mapping to each individual gene and quantify expression by the corresponding FPKM. In summary, expression was measured as FPKM for 25,054 unique genes. Principal component analysis was then performed to check for possible batch effects and outliers complemented by calculating the RNA-Seq 5'->3' trend for each sample. One sample for the vehicle control as well as for the Liraglutide group were identified as outliers and removed from subsequent analysis, resulting in 7 and 8 samples remaining for each group respectively. Abundance values (counts) were normalized and compared between liraglutide treated mice versus baseline controls using DESeq2. All P-values were adjusted for multiple testing by the Benjamini-Hochberg method.

Dataset Information

Short term monotherapy with GLP-1 receptor agonist liraglutide or PDE 4 inhibitor roflumilast is superior to metformin in weight loss in obese PCOS women: a pilot randomized study.

Publications

Short term monotherapy with GLP-1 receptor agonist liraglutide or PDE 4 inhibitor roflumilast is superior to metformin in weight loss in obese PCOS women: a pilot randomized study.

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