跳至主要内容
临床试验/CTRI/2025/01/079478
CTRI/2025/01/079478尚未招募不适用

Prevalence of Sarcopenic obesity in patients with Polycystic ovary syndrome and efficacy of individualised lifestyle modifications for treatment of Sarcopenic obesity: A Matched Case Control and pre-post intervention study.

ICMR1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2025年5月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
ICMR
入组人数
140
试验地点
1
主要终点
Prevalence of SO

研究概览

简要总结

·       Rationale/ gaps in existing knowledge

Sarcopenic obesity (SO) is a clinical and functional condition characterized by the coexistence of obesity, characterized by excess fat mass (FM), and sarcopenia (low skeletal muscle mass and function). Sarcopenic obesity is thought to be the consequence of dieting and the cause of weight management problems. SO research in low- and middle- income countries (LMICs) is very limited and comprehensive data on diagnosis and prevalence of SO in India are lacking therefore SO remains largely unsuspected and undiagnosed.

 Â·       Novelty

Despite several common risk factors for sarcopenic obesity and PCOS, the prevalence of SO in women with PCOS is currently not known. Present study is the first study nationally and internationally estimating prevalence of SO in women with PCOS, followed by development of individualised lifestyle modifications modules for  treatment of Sarcopenic obesity.

·       Objectives

To compare the proportion of sarcopenic obesity between an age-BMI matched women with PCOS diagnosed using Rotterdam criteria and healthy controls, assessing efficacy of individualised lifestyle modifications for treatment of Sarcopenic obesity. Furthermore, we want to compare the metabolic parameters, markers of inflammation and insulin resistance between SO and non-SO patients.

·       Methods

Seventy 18 to 35 years age women diagnosed with PCOS as cases and 70 age and BMI matched healthy controls will be recruited in the study. Body composition will be assessed once at the time of recruitment using dual-energy X-ray absorptiometry. At baseline metabolic parameters relevant to the study will be done. Nutritional status will be assessed using 24-hour recall method and food frequency questionnaire. After DEXA who come out to be sarcopenic obese will be given individualised lifestyle modifications (low glycaemic index diet with adequate protein as per RDA and resistant exercise training) for treatment of Sarcopenic obesity along with standard treatment.

 Â·       Expected outcome

o   Present study will estimate the prevalence of SO in PCOS patients. It will help in developing primary preventive measures and a screening strategy for SO.

o   Development of dietary and exercise modules specific for management of sarcopenic obesity.

o   Early detection of SO in PCOS, may help in tackling the long term adverse outcomes of SO like NCDs and may guide the healthcare professionals  in the management of PCOS having associated SO, as the treatment regime for SO is quite different as Obesity management strategies should cut fat, not muscle.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 35.00 Year(s)(—)
性别
Female

入选标准

  • a) Inclusion Criteria of cases o Age 18 to 35 years old, with confirmed clinical diagnosis for PCOS with Rotterdam criteria.
  • b) Inclusion Criteria of controls o Healthy females of 18-35 year age with BMI matched with regular menstrual cycles exhibiting no recent changes in menstrual patterns or abnormal elevations in follicle-stimulating hormone [FSH]).

排除标准

  • c) Exclusion Criteria o Pregnant and/or lactating mothers o Use of hormonal birth control methods or fertility medications during the prior 3 months.
  • o Women taking anti-seizure or anti-psychotic medications known to induce menstrual irregularity, hypolipidemic agents, antihypertensive medications, or antiaggregant/anticoagulants..
  • o Any medical history of conditions known to interfere with reproductive or metabolic function (besides PCOS) or bone and muscle metabolism, including diabetes mellitus, hyperprolactinemia, untreated thyroid dysfunction, premature ovarian failure, cushing disease, congenital adrenal hyperplasia, hyperparathyroidism, rheumatoid arthritis, renal disease, chronic obstructive pulmonary disease, and osteoporosis.

结局指标

主要结局

Prevalence of SO

时间窗: At baseline

次要结局

  • The efficacy of individualised lifestyle modifications among sarcopenic obese individuals will be done after repeating the DEXA and the Inflammatory marker hsCRP, insulin resistivity HOMA-IR, lipid profile, levels of HbA1C, vitamin-D levels at 12-weeks post intervention.(12 weeks)

研究者

发起方
ICMR
申办方类型
Government funding agency
责任方
Principal Investigator
主要研究者

Dr Deepali Garg

All India Institute of Medical Sciences, New Delhi

研究点 (1)

Loading locations...

相似试验