Dataset Information

A Pilot Trial: Fish Oil and Metformin Effects on ApoB-Remnants and Triglycerides in Women With Polycystic Ovary Syndrome.

ABSTRACT:

Context

Women with polycystic ovary syndrome (PCOS) have increased incidence of atherogenic dyslipidemia and cardiovascular disease (CVD). Interventions targeting atherogenic dyslipidemia to reduce CVD risk are limited in women with PCOS.

Objective

This pilot study was conducted to determine the effect of 12 weeks of high dose fish oil (FO), metformin, and FO as an adjunct to metformin (FO-metformin) therapy on fasting and nonfasting plasma lipids and ApoB-remnants in young women with the metabolic syndrome (MetS) and PCOS.

Methods

In this open-label parallel pilot trial, women with MetS and PCOS (18-30 years of age) were randomized into 1 of 3 interventions: (1) FO; (2) metformin; and (3) FO-metformin. Plasma lipids and ApoB (48 and 100)-lipoproteins and triglycerides (TG) were measured in the fasted and postprandial state following a high-fat meal at baseline and postintervention.

Results

FO-metformin significantly lowered fasting plasma TG by >40% compared with FO and metformin treatments. Fasting plasma apoB48 was lowered 40% in FO-metformin and 15% in the FO groups from baseline to postintervention. ApoB48 area under the curve (ApoB48_AUC), ApoB48 incremental AUC (ApoB48_iAUC), ApoB100_AUC, and ApoB100_iAUC decreased in all groups from baseline to postintervention; however, these findings did not reach statistical significance.

Conclusion

The findings of this pilot trial show that high dose FO and FO-metformin combination therapy tend to lower fasting and postprandial plasma TG and ApoB-lipoprotein remnants compared with metformin; however, the study is limited by small sample size. These results may be clinically significant in individuals with PCOS for management of atherogenic dyslipidemia.

SUBMITTER: Vine D

PROVIDER: S-EPMC8282216 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundObesity and insulin resistance (IR) are common features of polycystic ovary syndrome (PCOS). Metformin (MET) increases insulin sensitivity, but it is associated with unsatisfactory weight loss. The glucagon-like peptide-1 receptor agonist exenatide has been shown to reduce weight and IR in patients with diabetes. This study aimed to explore the therapeutic effects of exenatide once-weekly (QW) combined with MET on body weight, as well as metabolic and endocrinological parameters in overweight/obese women with PCOS.MethodsFifty overweight/obese women with PCOS diagnosed via the Rotterdam criteria were randomized to one of two treatment groups: MET (500 mg three times a day [TID]) or combination treatment (COM) (MET 500 mg TID, exenatide 2 mg QW) for 12 weeks. The primary outcomes were anthropometric changes associated with obesity, and the secondary outcomes included changes in reproductive hormone levels, glucose and lipid metabolism, and C-reactive protein.ResultsForty (80%) patients completed the study. COM therapy was superior to MET monotherapy in reducing weight (P = 0.045), body mass index (BMI) (P = 0.041), and waist circumference (P = 0.023). Patients in the COM group on an average lost 3.8 ± 2.4 kg compared with 2.1 ± 3.0 kg in the MET group. In the COM group, BMI and waist circumference decreased by 1.4 ± 0.87 kg/m2 and 4.63 ± 4.42 cm compared with 0.77 ± 1.17 kg/m2 and 1.72 ± 3.07 cm in the MET group, respectively. Moreover, levels of fasting glucose, oral glucose tolerance test (OGTT) 2-h glucose, and OGTT 2-h insulin were significantly lower with COM therapy than with MET (P < 0.050). Mild and moderate gastrointestinal reactions were the most common adverse events in both groups.ConclusionsCOM therapy was more effective than MET alone in reducing body weight, BMI, and waist circumference, and improving insulin sensitivity in overweight/obese women with PCOS, with acceptable short-term side effects.Trial registrationClinicalTrials.gov, NCT04029272. https://clinicaltrials.gov/ct2/show/NCT04029272.