Clinical Research Directory

Metabolic Responses of Metformin and Genetic Polymorphisms of SLC22A1 Gene in PCOS

The aim of this study is to see the associations of metabolic responses of metformin with single nucleotide polymorphisms (SNPs) (rs628031 and rs2282143) of solute carrier family 22 member 1 (SLC22A1) gene in women with polycystic ovary syndrome (PCOS). This prospective clinical study will be conducted in the department of Endocrinology, Bangabandhu Sheikh Mujib Medical University (BSMMU) from February 2023 to September 2024 over a period of two years. A total of at least 100 women with PCOS (18 - 35 years) diagnosed based on International Evidence-based Guideline for PCOS 2018, will be included consecutively by convenient sampling. After taking informed written consent, relevant clinical history will be taken and physical examinations will be done at baseline. Following a run in phase of three weeks, patients will visit thrice after 1, 12 \& 24 weeks of metformin maintenance therapy with a window period of 14 days both ways. Blood samples will be collected in fasting state at baseline and after 24 weeks of treatment to measure glycemic status, lipid profile, fasting insulin, c-peptide and detection of SLC22A1 gene (rs628031 and rs2282143) polymorphisms. Glucose will be measured by glucose oxidase method, lipids by glycerol phosphate dehydrogenase peroxidase method, insulin by chemiluminescent microparticle immunoassay, c-peptide by enzyme-linked immunosorbent assay (ELISA) and genetic analysis of rs628031 and rs2282143 by polymerase chain reaction-restriction fragment length polymorphism (PCR-RFLP).

NAFLD in Adolescents and Young Adults With PCOS

This project focuses on an at-risk adolescent and young adult population who may gain long-term health benefits from detection of risk factors at a young age. The primary aims of this proposal are: 1) To observe whether adolescents and young adults with Polycystic Ovary Syndrome (PCOS) are more likely to have elevated liver fat (\>/=4.8%) than controls by studying liver fat deposition measured by magnetic resonance spectroscopy (MRS); 2) To assess the association of percentage liver fat with biomarkers of Non-alcoholic fatty liver disease (NAFLD), dyslipidemia, insulin resistance and body composition in PCOS and controls. In the proposed study, 40 adolescents and young adults with PCOS and 40 age-comparable control subjects will be evaluated for metabolic disturbances and elevated liver fat using noninvasive and state-of-the-art techniques including MRI, dual-energy x-ray absorptiometry and an oral glucose tolerance test in order to fully assess the metabolic and body composition differences between these groups. This research proposal represents a critical step in understanding the metabolic and cardiovascular comorbidities of PCOS and their relationship to NAFLD. The investigator hopes to use the results generated by this research proposal in order to lay the groundwork for the prevention and treatment of metabolic disorders in adolescents with PCOS. The overarching goal is to decrease and prevent lifelong morbidity associated with this common disorder.

Inositol in Letrozol Resistant PCOS Women

Polycystic ovary syndrome (PCOS),is a complex neuro-endocrine disorder affecting approximately 5% to 10% of women in reproductive age.Inositols are considered insulin sensitizers, as they modulate the members of insulin signaling pathways.Thiss study compares between the effect of inositol and metformin in letrozol resistant PCOS women.

Metabolic and Hormonal Parameters in Women With Polyendocrine Metabolic Ovarian Syndrome

Polyendocrine Metabolic Ovarian Syndrome (PMOS) is a common endocrine and metabolic disorder associated with insulin resistance, hyperandrogenism, and an increased risk of long-term metabolic complications. Fetuin-A and resistin are adipokines implicated in insulin resistance and chronic inflammation and may serve as potential biomarkers for metabolic dysfunction in women with PMOS. This prospective observational case-control study aims to compare serum and salivary Fetuin-A and resistin levels between women with PMOS and healthy controls. The study will evaluate the correlation between serum and salivary biomarker concentrations and investigate their associations with insulin resistance, lipid profile, and hormonal parameters. The findings may help determine whether salivary measurements can serve as reliable non-invasive biomarkers for the diagnosis and metabolic assessment of PMOS.

Efficacy of Mazdutide for Treating PCOS

The goal of this clinical trial is to learn the efficacy of Mazdutide in treating obese female adults diagnosed with polycystic ovary syndrome (PCOS). The main question it aims to answer is: Does Mazdutide lower the free androgen index (FAI) in obese female adults with PCOS? Participants will take Mazdutide once every week for 24 weeks and visit the clinic once every 4 weeks for checkups and tests.

Body Fat as Determinant of Female Gonadal Dysfunction

Reproduction requires from women enough energy depots to warrant an adequate nutritional supply to the fetus. Hence, adipose tissue is able to communicate with female hypothalamic-pituitary-ovary axis. The hypothesis of the project is that abnormalities in the quantity (absolute and relative to lean body mass), distribution and/or function of adipose tissue are associated with functional forms of female gonadal dysfunction in predisposed women, in a spectrum of anomalies that go from hypothalamic amenorrhea to the polycystic ovary syndrome (PCOS). To challenge this hypothesis, the investigators will study 5 groups of 10 women each: women with exercise-associated hypothalamic amenorrhea, women without ovulatory dysfunction that exercise equally, non-hyperandrogenic patients with PCOS, hyperandrogenic patients with PCOS, and healthy control women comparable to those with PCOS. The aims of the study will be: Primary objective: To identify novel signalling factors originating from adipose tissue and muscle using targeted and nontargeted evaluation of the proteome and of gene expression of superficial subcutaneous fat, deep subcutaneous fat (which mimics visceral adipose tissue) and skeletal muscle. Secondary objectives: 1. To study the serum adipokine profile - including those identified by the primary objective - and circulating gut hormones during fasting and after a glucose load in the 5 groups of women, and their associations with sexual hormones and body fat distribution. 2. To study body composition and body fat distribution in these women and their relationships with: 2.1, Sex steroid profiles. 2.2. Classic cardiovascular risk factors: carbohydrate metabolism, lipid profiles and blood pressure. 2.3 Markers of low-grade chronic inflammation. 2.4. Oxidative stress markers. 2.5. Cardiovascular autonomic function. 2.6. Surrogate markers of subclinical atherosclerosis. 2.7. Circulating concentrations of endocrine disruptors. 2.8. Oral and gut microbiome. The results will provide a better understanding of the mechanisms linking body energy depots with the female reproductive axis and, hopefully, the identification of potential biomarkers for the diagnosis and treatment of the disorders studied here.

The Physiological Responses and Adaptation of Brown Adipose Tissue to Chronic Treatment With Beta3-Adrenergic Receptor Agonists

Background: Brown adipose tissue (BAT) is a type of fat in the body. It may prevent weight gain, improve insulin sensitivity, and reduce fatty liver. Researchers want to see if BAT helps the body burn energy. Objective: To learn more about how BAT works to burn energy. Eligibility: People ages 18-40 with a body mass index between 18 and 40 Design: Participants will be screened with: Medical history Physical exam Blood, urine, and heart tests Dietitian interview Participants will have an overnight baseline visit. This includes: Repeats of screening tests Exercise test Scans. For one scan, a radioactive substance is injected into the arm. FSIVGIT: An IV is inserted into veins in the right and left arms. Glucose and insulin are injected in one arm. Blood glucose and insulin levels are measured from the other. Metabolic suite: Participants stay 18-19 hours in a room that measures their metabolic rate. Monitors on the body measure heart rate, movement, and temperature. Optional fat biopsy: A small piece of tissue is removed with a needle. Participants will take 2-4 pills daily for 4 weeks. All women will take the drug mirabegron. Men will be randomly get either the drug or a placebo. All participants will have a visit after 2 weeks of the pills. They will repeat the screening tests. Participants will have an overnight visit 2 weeks later. They will repeat the baseline tests. Participants will keep food and medication diaries. Participants will have a follow-up visit 2 weeks after stopping the pills. This includes heart tests.

The REBALANCE Study - a Prospective, Multicenter, Randomized, Pivotal Study of the May Health System

A Prospective, Multicenter, Randomized, Pivotal Study of the May Health System in Transvaginal Ablation of Ovarian Tissue under Ultrasound Guidance in Women with Infertility due to Polycystic Ovary Syndrome

Acupuncture for Insulin Resistance in Women With Polycystic Ovary Syndrome

This two-stage clinical research programme aims to evaluate the preliminary effectiveness and safety of acupuncture for improving insulin resistance in women with polycystic ovary syndrome (PCOS). Phase I will be a prospective, single-centre, open-label, single-arm exploratory trial involving 20 participants, all of whom will receive active acupuncture plus lifestyle management. Acupuncture will be administered three times per week for 12 weeks, followed by a 12-week follow-up period. The study will primarily assess safety, tolerability, feasibility, and the preliminary change in the homeostatic model assessment of insulin resistance (HOMA-IR) from baseline to Week 12. The effect size and variability of HOMA-IR change, together with safety, adherence, and dropout data obtained from Phase I, will be used to determine the sample size and finalize the design of Phase II. Phase II is planned as a prospective, multicentre, parallel, randomized, participant- and outcome assessor-blinded, sham-controlled trial comparing active acupuncture plus lifestyle management with sham acupuncture plus lifestyle management to confirm the effectiveness and safety of the intervention.

Effect of Sitagliptin on Polycystic Ovarian Syndrome Patients

The Study aims to determine the proposed positive influence of Sitagliptin in manipulating hormonal , metabolic and inflammatory parameters in the treatment of Polycystic ovary syndrome and subsequent infertility

Myo-Inositol for Ovarian Stimulation and ICSI Outcomes in Women With PCOS

Polycystic ovary syndrome (PCOS) is a common endocrine disorder that may affect ovarian function, insulin sensitivity, and fertility. Myo-inositol has been proposed as an insulin-sensitizing supplement that may improve metabolic and reproductive outcomes in women with PCOS. This randomized, double-blind clinical trial evaluated the effect of myo-inositol supplementation on controlled ovarian stimulation and assisted reproductive technology (ART) outcomes in women with PCOS undergoing in vitro fertilization (IVF) and/or intracytoplasmic sperm injection (ICSI). A total of 88 participants were randomly assigned to two parallel groups. The intervention group received myo-inositol combined with folic acid, while the control group received folic acid alone for 3 months before the ART cycle and until the day of oocyte retrieval. The study assessed whether myo-inositol could improve metabolic and hormonal parameters, ovarian response to stimulation, oocyte and embryo quality, and pregnancy outcomes, while also evaluating ovarian hyperstimulation syndrome (OHSS).

Evaluation of the Venous Thrombotic Biological Profile of Different PCOS Phenotypes: French Cross-sectional Study

Polycystic ovary syndrome (PCOS) is the most common endocrine disorder of women of childbearing age. PCOS can be individualized into several phenotypes, taking into account in particular the presence of hyperandrogenism, insulin resistance and BMI. Hyperandrogenism and insulin resistance appear to be important factors in the development of cardiovascular cardiovascular disease. In addition, patients frequently use anti-androgenic and/or contraceptive treatments contraceptives, such as combined hormonal contraception (CHC), the use of which is associated with an increased cardiovascular and thrombo and venous thrombosis (VTE). A meta-analysis published in 2020 by Gariani et al. based on three large studies, estimated the risk of VTE in women with PCOS after adjustment for obesity and hormone therapy. This risk was significantly higher compared with women without PCOS (pooled OR 1.89, CI95% 1.60-2.24). No study has looked specifically investigated the risk of VTE according to different PCOS phenotypes. Such data would be very useful in clinical practice, as it would enable monitoring, contraceptive treatment and anti-androgenic anti-androgen treatment according to the PCOS phenotype, while limiting risks. Assessing the differences PCOS phenotypes is limited by the large sample size required. required. VTE is a rare event in women of childbearing age, and the number of PCOS phenotypes is high. PCOS phenotypes. Intermediate markers of VTE risk are used in these situations. These markers are thrombin generation tests (notably ETP) and their sensitivity to activated protein C (nAPCsr) and thrombomodulin (nTMsr), as well as sex-hormone binding globulin (SHBG).

Identification of Women With Severe Insulin Resistant Syndromes of Genetic Origin Among Patients With "Classic" Polycystic Ovary Syndrome (PCOS)

Diagnostic case-control study (1 case for 2 controls). Inclusion of patients with severe insulin resistance syndrome of genetic origin, then inclusion of controls: patients examined for PCOS in day hospital with matching age (+/- 5 years) and Body mass index (+/- 5kg/m2).

Effect of Orlistat on Metabolic and Hormonal Features in Women With Polycystic Ovary Syndrome (PCOS): a Randomized Controlled Clinical Trial

This randomized controlled clinical trial aims to evaluate the effect of orlistat on the metabolic and hormonal features of women with polycystic ovary syndrome (PCOS). Eligible women diagnosed with PCOS according to the Rotterdam criteria will be randomly assigned to receive either orlistat plus standard lifestyle advice or placebo plus standard lifestyle advice for three months. The study will assess the effect of orlistat on hormonal parameters, glucose metabolism, lipid profile, liver function, anthropometric measures, non-alcoholic fatty liver disease, and quality of life to determine its effectiveness as an adjunctive treatment for women with PCOS.

Effect of High Intensity Interval Training on Insulin Resistance in Polycystic Ovarian Syndrome

This study will be conducted to investigate the effect of high- intensity interval training on insulin resistance in polycystic ovarian syndrome.

Combined Oral Contraceptive Pill and Resistance Starch

This study will enroll women with PCOS to study the effects of first line therapy, oral contraceptive pills, and then either 12 weeks of resistant starch or 12 weeks of placebo to explore if resistant starch improves cardiometabolic parameters or impacts gut dysbiosis compared to placebo.

Clinical and Basic Research on the Treatment of Polycystic Ovary Syndrome

Polycystic ovary syndrome is the most common endocrine and metabolic disorder in gynecology. Traditional Chinese medicine has a good clinical effect in the treatment of PCOS. We intend to conduct this trial in strict accordance with the requirements of evidence-based medicine, through a multi-center, randomized, controlled study, using a double-blind, randomized, placebo-controlled study design method to clarify that Zishen Qingre Lishi Huayu Recipe restores spontaneous ovulation in PCOS patients. The overall efficacy of improving the characteristics of Kaohsiung and glucose and lipid metabolism is optimal, and high-level evidence-based evidence is obtained to form a diagnosis and treatment plan for promotion.

Myo-Inositol for Infertility in PCOS

This will be a prospective, double-blind randomized clinical trial of letrozole and placebo versus letrozole and inositols for up to 5 treatment cycles of ovulation induction or until pregnancy is achieved. All participants and members of the research team will be blinded to the treatment arms. Placebo and inositol supplement will be packaged to appear the same, tested, and packaged by a commercial supply company. The inositols will be a 40:1 blend of myo-inositol and D-chiro inositol.

Intermittent Fasting Diet Versus Resistive Exercise Program on Insulin Resistance in Obese Women With P.C.O.S

This study will be carried out in an attempt to know which is more effective, Intermittent fasting diet or resistive exercise program on insulin resistance in obese woman with polycystic ovarian syndrome.

Determinants of Insulin Sensitivity by Age, Sex, Race/Ethnicity, BMI, and PCOS Diagnosis

The study aims to investigate the relationship between fasting insulin and Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) across various demographic factors, including age, sex, race/ethnicity, BMI, and polycystic ovary syndrome (PCOS) diagnosis. By analyzing these variables, the study seeks to identify potential variations in insulin levels, which could provide valuable insights into the impact of different factors on metabolic health and the development of insulin-related conditions.

Evaluation of the Effect of Time-Restricted Feeding and Mediterranean Diet Model in Women With Polycystic Ovary Syndrome

Currently, there is still insufficient data to support the long-term efficacy, safety, and health benefits of time-restricted feeding models in women diagnosed with Polycystic ovary syndrome (PCOS), and further studies are needed to test and validate the effects of long-term dietary management in PCOS. On the other hand, similarly, studies investigating the effects of the Mediterranean Diet on body composition and dietary intake in women with PCOS are limited. The primary aim of this research is to examine the effect of time-restricted feeding and the Mediterranean diet model on body composition and dietary intake in adult women diagnosed with PCOS. The secondary aim is to evaluate the effect of different dietary models on quality of life in women diagnosed with PCOS.

Interest of Myo-inositol Supplementation in Women With Polycystic Ovarian Syndrome

The main objective will be to check if MyoInositol (MYO) reduces the total resistance rate to Clomiphene Citrate (CC). For this, our study will be controlled, randomized and double blinded. It will include patients with PCOS (polycystic ovary syndrome, defined by the Rotterdam criteria) who wish to become pregnant and are eligible to simple ovulation induction by CC. Half of them will receive MYO + levomefolic acid (5-MTHF) in addition to the CC, while the other half will receive a placebo containing only 5-MTHF in addition to the CC. The MYO supplementation will be initiated at least one month before taking CC and will be continued throughout this treatment until pregnancy or before switching to another type of treatment for ovulation induction if no pregnancy is obtained after 6 ovulatory cycles.

SGLT2 Inhibitors in Treating Patients With PCOS

Chronic inflammation is the core of Polycystic ovary syndrome (PCOS), and obesity and overweight further exacerbate the level of inflammation in the peripheral circulation and ovarian tissue in PCOS patients. Metformin is a classic endocrine drug for the treatment of PCOS, but its clinical response rate is only about 40%. Our previous published study (Diabetes Obes Metab, 2022) observed that the new hypoglycemic drug SGLT-2 inhibitor can significantly improve the clinical symptoms of patients with insulin resistance PCOS, and the clinical efficacy is not inferior to metformin, but its specific mechanism of action is not clear. Recent studies have shown that SGLT-2 significantly attenuates the activation of the Nod-like receptor protein 3 (NLRP3) inflammasomes and the secretion of IL-1β in patients with type 2 diabetes mellitus at high risk of cardiovascular disease. Based on the above research background, this project will combine clinical research and mechanism exploration to solve the following two problems: 1. whether SGLT2 inhibitor can further improve the clinical efficacy of PCOS patients compared to metformin; 2. mechanistic studies further clarify whether SGLT2 inhibitors improve inflammatory symptoms by modulating NLRP3 inflammosomes in the treatment of polycystic ovary syndrome;

Glucose Profiles in Women With Polycystic Ovary Syndrome

Polycystic ovary syndrome is a very common condition that is associated with metabolic complications. Patients with polycystic ovary syndrome exhibit insulin resistance and are at greater risk to develop type 2 diabetes. This syndrome is heterogeneous, classified according to 4 phenotypes (A-D). It seems that certain phenotypes are less exposed to insulin resistance and metabolic complications. However, only a few studies have evaluated the glucose profile according to phenotype. New technologies now make it possible to monitor glucose levels continuously. The aim of this project is to evaluate glucose profile parameters using continuous glucose monitoring, and to compare these profiles according to different PCOS phenotypes.