Body Fat Indices, Fatty Acid Oxidation capacity and Inflammatory crosstalk in Gestational Diabetes Mellitus: Insights into Insulin Resistance and its impact on Maternal-Fetal Risk.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Differences in body fat indices: Fat weight, Body fat Percentage, Fat Mass Index, Fat Free mass index, Carnitine Palmitoyl Transferase 1 activity, and inflammatory marker levels: Tumour Necrosis Factor alpha, Interleukin 6 between Insulin Resistant GDM and healthy pregnant controls
研究概览
简要总结
The pregnant women attending the antenatal clinic will be screened using the inclusion and exclusion criteria and included into the study Eligible participants will be provided with detailed information about the study including its purpose procedures potential risks and benefits and their rights as research participants Informed consent will be obtained from each participant prior to their enrollment in the study Participants will be given ample opportunity to ask questions and clarify any concerns before providing consent The routine investigations performed as standard of care during the Antenatal Visit include Hemoglobin Random Blood Sugar Fasting Blood Sugar Post Prandial Blood Sugar Glycosylated Hemoglobin The lab investigation reports of the tests will be collected by the Principal Investigator The Ultrasound scan parameters done as part of routine care will also be recorded After the routine investigation the demographic details of the pregnant woman will be collected using the Case Report Form OGTT is done from 12 to 28 weeks GDM will be diagnosed in line with the following International Association of Diabetes in Pregnancy Study Group standards No history of Diabetes Mellitus before pregnancy but the 75g OGTT fasting plasma glucose level of 92 mgdL 1h postprandial plasma glucose level of 180 mgdL or 2h postprandial plasma glucose of 153 mgdL will be considered as GDM If the OGTT is positive Homeostasis Model Assessment of Insulin Resistance HOMAIR will be calculated based on the glucose and insulin values HOMA IR will be calculated by log Fasting Glucose in mgdl x Fasting Insulin in micro IU per ml divided by 405 If the HOMA is 2 the patients will be included in the Insulin Resistance Gestational Diabetes Mellitus group The investigations for the purpose of this study include CPT1 Assay Insulin Assay for HOMAI R inflammatory markers TNF alpha and Interleukin 6 and antioxidants SOD GSH and MDA An additional 4ml Blood sample will be collected after the diagnosis of GDM for these investigations in the study Apart from these tests the remaining blood which is leftover after performing these tests will be stored for future metabolomic studies using the same sample Blood is collected in Vacutainers Red insulin CPT1 Grey Fasting glucose The samples will be transported to the lab within 60 minutes centrifuged and aliquoted to tubes and stored at 80C The following parameters will be analyzed CPT1 insulin and fasting glucose After thawing preparation of the sample will be done based on the SOP Appropriate data cleaning and analysis will be done SOD GSH and MDA will be done on the thawed samples according to the SOP CPT 1 will be assayed using sandwich ELISA on 96 well plates in the Department of Biochemistry Insulin will be assayed using sandwich ELISA on 96 well plates in the Department of Biochemistry The InBody test a bioelectrical impedance analysis BIA method measures body composition by sending a lowlevel electrical current through the body to determine the resistance of different tissues The procedure typically involves standing on the device with electrodes placing thumbs on handles with electrodes and maintaining a specific posture while the test is conducted InBody devices use segmental BIA which measures the impedance of different body segments Body fat composition will be done for the following parameters BMI Body Fat Mass Percentage Body Fat Fat Free Mass Skeletal Muscle Mass Followup will be conducted to collect data on fetal weight type of delivery and occurrence of preterm labor These details will primarily be obtained from hospital records at the time of delivery In cases of loss to followup or incomplete records information will be collected through telephonic contact with the patient
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)(—)
- 性别
- Female
入选标准
- •Pregnant women diagnosed with GDM according to IADPSG criteria.
排除标准
- •Pre-existing diabetes mellitus (Type 1 or Type 2) Medical conditions (hypertension, renal disease, thyroid disorders, epilepsy) Chronic or Acute Infections Use of medications known to affect glucose metabolism, like Insulin, Anti-diabetic medications, and hypolipidemic medications.
结局指标
主要结局
Differences in body fat indices: Fat weight, Body fat Percentage, Fat Mass Index, Fat Free mass index, Carnitine Palmitoyl Transferase 1 activity, and inflammatory marker levels: Tumour Necrosis Factor alpha, Interleukin 6 between Insulin Resistant GDM and healthy pregnant controls
时间窗: Baseline
次要结局
- Predictive association of Fat Mass Index, Carnitine Palmitoyltransferase 1 activity, & inflammatory markers Tumor Necrosis Factor-alpha & Interleukin-6 with composite adverse pregnancy defined as the occurrence of any one or more of the following: macrosomia, caesarean delivery, neonatal hypoglycaemia, or Neonatal Intensive Care Unit admission.(At the time of delivery of baby)
- To correlate Body Fat Indices Fat Weight, Body Fat Percentage, Fat Mass Index, Fat Free Mass Index, Carnitine Palmitoyltransferase 1 activity, & inflammatory markers Tumor Necrosis Factor alpha, Interleukin 6 with Homeostasis Model Assessment of Insulin Resistance scores(Baseline)
研究者
Melwin Maben
Kasturba Medical College Manipal
