Metabolic Syndrome Clinical Trial
— MetS_PregOfficial title:
The Progression of Metabolic Syndrome Components During Pregnancy, and the Risks for Adverse Pregnancy Outcomes in Jimma Zone, Southwest Ethiopia: A Prospective Cohort Study.
The goal of this cohort study is to investigate the underlying risk factors to develop metabolic syndrome (MetS) during pregnancy, and the associations of MetS and its indicators with birth outcomes in southwest Ethiopia. The study population consists of low-risk pregnant ladies in their first antenatal care visit (ANC), from Jimma Medical center. The main question[s] it aims to answer are: i) How do MetS components progress during pregnancy, and what are the underlying risk factors? ii) What is the association between MetS components during early- and late pregnancy and adverse pregnancy outcomes? iii) What is the knowledge, attitude and practices of women toward dietary habits, food taboos, and cultural beliefs during pregnancy? The study population consists of low-risk pregnant ladies in their first trimester (<15 weeks of pregnancy) in their first antenatal care visit (ANC) who will be followed up until one-month postpartum. Enrolled women will be assessed four times: at enrolment ≤15 weeks of pregnancy, mid-pregnancy (at 24 weeks), and late pregnancy (at 36 weeks), and within two weeks post-partum for: 1. Sociodemographic data 2. Dietary intake 3. Biochemical analyses 4. Maternal anthropometry: 5. Body composition in a subsample. 6. Knowledge, attitudes and practices of dietary practices during pregnancy 7. Pregnancy and birth outcomes: During the final visit, new born babies will be assessed for Apgar score, weight, length, and head circumference. The mother will be examined for general health and mode of delivery.
Status | Recruiting |
Enrollment | 526 |
Est. completion date | December 30, 2024 |
Est. primary completion date | June 15, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility | Inclusion Criteria: - Apparently healthy women with (or without) at least one of the 5 individual components of MetS will be enrolled in the study from each selected health institution if they meet all the inclusion criteria. Inclusion criteria for the exposed group include additionally: 1. Abdominal obesity defined as waist circumference = 2 standard deviations (SD) for gestational age in the first half of pregnancy or presentational BMI >30 kg/m2, OR 2. Raised triglycerides (>1.70 mmol/l [>150 mg/dl]), OR 3. Reduced high-density lipoprotein cholesterol (<1.29 mmol/l [<50 mg/dl]), OR 4. Raised blood pressure (BP) (i.e., systolic BP >130 mm Hg or diastolic BP >85 mm Hg), OR 5. Raised plasma glucose (>5.6 mmol/l). Exclusion Criteria: - Pregnant women with chronic hypertension that necessitates medication, diabetes (also under medication), or any severe chronic illness will not be eligible to participate in the study. Women who have HIV and who take antiretroviral therapy (ART) are also not eligible because of the side effect of ART. Additionally, non-consenting women, =18 years old, women who are planning to move outside the study area within the study timeframe due to job transfer or study leave, or those who are not willing to adhere to the prospective follow up visits will not be included in the study. Women whose ultrasound confirmed, twin pregnancy, congenital anomaly or fetal death in utero will not be included in the study. |
Country | Name | City | State |
---|---|---|---|
Ethiopia | Jimma University Medical Center | Jimma |
Lead Sponsor | Collaborator |
---|---|
University Ghent | Flemish Interuniversity Council (VLIR), Jimma University |
Ethiopia,
Alberti KG, Zimmet PZ. Definition, diagnosis and classification of diabetes mellitus and its complications. Part 1: diagnosis and classification of diabetes mellitus provisional report of a WHO consultation. Diabet Med. 1998 Jul;15(7):539-53. doi: 10.1002/(SICI)1096-9136(199807)15:73.0.CO;2-S. — View Citation
Aldridge E, Pathirana M, Wittwer M, Sierp S, Leemaqz SY, Roberts CT, Dekker GA, Arstall MA. Prevalence of Metabolic Syndrome in Women After Maternal Complications of Pregnancy: An Observational Cohort Analysis. Front Cardiovasc Med. 2022 Mar 14;9:853851. doi: 10.3389/fcvm.2022.853851. eCollection 2022. — View Citation
Berhe AK, Ilesanmi AO, Aimakhu CO, Mulugeta A. Effect of pregnancy induced hypertension on adverse perinatal outcomes in Tigray regional state, Ethiopia: a prospective cohort study. BMC Pregnancy Childbirth. 2019 Dec 31;20(1):7. doi: 10.1186/s12884-019-2708-6. — View Citation
Chatzi L, Plana E, Pappas A, Alegkakis D, Karakosta P, Daraki V, Vassilaki M, Tsatsanis C, Kafatos A, Koutis A, Kogevinas M. The metabolic syndrome in early pregnancy and risk of gestational diabetes mellitus. Diabetes Metab. 2009 Dec;35(6):490-4. doi: 10.1016/j.diabet.2009.07.003. — View Citation
Grieger JA, Bianco-Miotto T, Grzeskowiak LE, Leemaqz SY, Poston L, McCowan LM, Kenny LC, Myers JE, Walker JJ, Dekker GA, Roberts CT. Metabolic syndrome in pregnancy and risk for adverse pregnancy outcomes: A prospective cohort of nulliparous women. PLoS Med. 2018 Dec 4;15(12):e1002710. doi: 10.1371/journal.pmed.1002710. eCollection 2018 Dec. — View Citation
Muche AA, Olayemi OO, Gete YK. Gestational diabetes mellitus increased the risk of adverse neonatal outcomes: A prospective cohort study in Northwest Ethiopia. Midwifery. 2020 Aug;87:102713. doi: 10.1016/j.midw.2020.102713. Epub 2020 May 19. — View Citation
Vasilevski V, Carolan-Olah M. Food taboos and nutrition-related pregnancy concerns among Ethiopian women. J Clin Nurs. 2016 Oct;25(19-20):3069-75. doi: 10.1111/jocn.13319. Epub 2016 Jul 14. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Prevalence of participants with nutrition knowledge | Knowledge, attitudes and practices of dietary practices during pregnancy: Using a structured questionnaire, the knowledge, attitudes and practices of the women regarding food taboos and cultural norms during pregnancy will be assessed. | At baseline in all participants | |
Other | Fat-free mass | Fat-free mass (Kg) will be measured using the BOD POD. | At baseline in a sub-sample of participants | |
Primary | Birth weight | Birth weight (g) | Birth weight will be assessed up to 28 weeks after enrollment | |
Primary | Infant length | Infant length (cm) | Infant length will be assessed up to 28 weeks after enrollment | |
Primary | Gestational age at birth | Gestational age at birth in weeks will be used to define preterm (babies born alive prior to 37 completed weeks of gestation), term birth (birth between 37 and 42 weeks), and post-term (birth after 42 weeks of gestation). | It is measured in weeks, from the first day of the woman's last menstrual cycle to the day of birth. | |
Primary | Preeclampsia (PE) | Defined as systolic BP >140 mm Hg or diastolic BP >90 mm Hg, or both, on at least 2 occasions at least 4 hours apart after 20 weeks' gestation but before the onset of labour, or postpartum, with either proteinuria (24-hour urinary protein >300 mg or spot urine protein:creatinine ratio >30 mg/mmol creatinine) or any multisystem complication of PE. | In all participating women up to 28 weeks after enrollment | |
Primary | Gestational diabetes (GDM) | Defined if fasting glucose of >5.1 mmol/l. | In all participating women up to 28 weeks after enrollment | |
Secondary | Infant head circumference | Infant head circumference (cm) | Infant head circumference will be assessed up to 28 weeks after enrollment | |
Secondary | High triglyceride concentrations | High triglyceride level [>150 milligrams per deciliter (mg/dL)] | At baseline and through follow-up up to 28 weeks after enrollment | |
Secondary | High-density lipoprotein (HDL) cholesterol | HDL cholesterol concentrations <50 mg/dL | At baseline and through follow-up up to 28 weeks after enrollment | |
Secondary | High blood pressure | Blood pressure > 130/85 mm Hg | At baseline and through follow-up up to 28 weeks after enrollment | |
Secondary | High levels of fasting blood sugar | Fasting glucose > 105 mg/dL | At baseline and through follow-up up to 28 weeks after enrollment | |
Secondary | Maternal weight | Maternal weight (Kg) | Maternal weight will be measured at baseline | |
Secondary | Maternal height | Maternal height (cm) | Maternal height will be measured at baseline | |
Secondary | Dietary intake during six months pregnancy | Prevalence of women with adequate dietary intake during six months pregnancy | Assessed at 12 weeks and 24 weeks after enrollment |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04635202 -
Effect of Elliptical Training on Metabolic Homeostasis in Metabolic Syndrome
|
N/A | |
Completed |
NCT05343858 -
Pilot Study to Evaluate the Effect of Two Microalgae Consumption on Metabolic Syndrome
|
N/A | |
Completed |
NCT04053686 -
An Intervention to Reduce Prolonged Sitting in Police Staff
|
N/A | |
Active, not recruiting |
NCT05891834 -
Study of INV-202 in Patients With Obesity and Metabolic Syndrome
|
Phase 2 | |
Recruiting |
NCT05040958 -
Carotid Atherosclerotic Plaque Load and Neck Circumference
|
||
Completed |
NCT03644524 -
Heat Therapy and Cardiometabolic Health in Obese Women
|
N/A | |
Active, not recruiting |
NCT02500147 -
Metformin for Ectopic Fat Deposition and Metabolic Markers in Polycystic Ovary Syndrome (PCOS)
|
Phase 4 | |
Recruiting |
NCT03227575 -
Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control
|
N/A | |
Recruiting |
NCT05972564 -
The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function
|
Phase 1/Phase 2 | |
Completed |
NCT03289897 -
Non-invasive Rapid Assessment of NAFLD Using Magnetic Resonance Imaging With LiverMultiScan
|
N/A | |
Recruiting |
NCT05956886 -
Sleep Chatbot Intervention for Emerging Black/African American Adults
|
N/A | |
Completed |
NCT06057896 -
Effects of Combined Natural Molecules on Metabolic Syndrome in Menopausal Women
|
||
Active, not recruiting |
NCT03613740 -
Effect of Fucoxanthin on the Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion
|
Phase 2 | |
Completed |
NCT04498455 -
Study of a Prebiotic Supplement to Mitigate Excessive Weight Gain Among Physicians in Residency
|
Phase 4 | |
Completed |
NCT05688917 -
Green Coffee Effect on Metabolic Syndrome
|
N/A | |
Completed |
NCT04117802 -
Effects of Maple Syrup on Gut Microbiota Diversity and Metabolic Syndrome
|
N/A | |
Completed |
NCT03697382 -
Effect of Daily Steps on Fat Metabolism
|
N/A | |
Completed |
NCT03241121 -
Study of Eating Patterns With a Smartphone App and the Effects of Time Restricted Feeding in the Metabolic Syndrome
|
N/A | |
Completed |
NCT04509206 -
Virtual Teaching Kitchen
|
N/A | |
Completed |
NCT05124847 -
TREating Pediatric Obesity
|
N/A |