- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT02395835
Methylation of the PPARg Promoter Region in Pregnancy
Methylation Evaluation of the PPARg Promoter Region (-351 to -260) in Pregnancy
Přehled studie
Postavení
Podmínky
Detailní popis
Women were recruited in the first trimester of pregnancy not including cases with congenital heart and disabling or autoimmune diseases. Those whose clinical follow-up were lost or, if in the postpartum period, who had to be attended in the obstetric intensive care unit were eliminated from the study.
A clinical visit per month was established. Body weight and height were measured in an overnight fasting status using an adult scale (Seca, Hamburg, Germany). Prepregnancy Body Mass Index (BMI) was calculated as weight in kg divided by height in meters squared based on the prenatal chart or on the self-reported weight of women with no prenatal chart.
Blood pressure was recorded at each visit using a standard sphygmomanometer (Riester Big Ben® Square, Germany). Preeclampsia was diagnosed and classified according to the American College of Obstetricians and Gynecologists (ACOG).
Fasting blood samples (10 ml) were taken at the HMPMP laboratory in an early morning after an overnight fasting. Serum samples were analyzed for glucose and lipid profile (Dimension Rx L Max, Dade Behring, USA). At the end of pregnancy, 1 to 2 ml of neonatal peripheral blood sample for leukocyte DNA extraction was taken.
Dietetic treatment was calculated according to height, weeks of gestation, and weight, considering an energy intake of 30 kcal/kg of ideal weight and a macronutrient distribution of: 55-65% carbohydrates, 10-20% fat, and the remainder as proteins. On each nutritional visit, the Healthy Eating Index for Pregnancy (HEI) was evaluated, and all women were recommended to include methionine-rich foods (beans, eggs, fish, garlic, lentils, onion, and soy) and those containing folic acid and vitamin B12 (beef liver, cereals, whole grains, yeast, etc.) in adequate quantities in their diet. The information was complemented with the Food Frequency Questionnaire (FFQ), and the diet adherence was considered adequate with 80% compliance to the indicated calories, at least in four visits.
This project had no risk to pregnant women and their infants, according to the regulations of the General Health Research Law of Mexico. We followed the Declaration of Helsinki, and all patients were asked to sign the written informed consent.
Typ studie
Zápis (Aktuální)
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
Inclusion Criteria: Women attended in the first trimester of pregnancy -
Exclusion Criteria: congenital heart and disabling or autoimmune diseases
-
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
|---|
|
Normal weight (NW) pregnant women
Pregnant women with Body Mass Index (BMI) > = 30. Body weight and height were measured in an overnight fasting status using an adult scale (Seca, Hamburg, Germany). Prepregnancy BMI was calculated as weight in kg divided by height in meters squared based on the prenatal chart or on the self-reported weight of women with no prenatal chart. Dietetic treatment was calculated according to height, weeks of gestation, and weight, considering an energy intake of 30 kcal/kg of ideal weight and a macronutrient distribution of: 55-65% carbohydrates, 10-20% fat, and the remainder as proteins. |
|
Overweight (OW) pregnant women
Pregnant women with Body Mass Index (BMI) < 30. Body weight and height were measured in an overnight fasting status using an adult scale (Seca, Hamburg, Germany). Prepregnancy BMI was calculated as weight in kg divided by height in meters squared based on the prenatal chart or on the self-reported weight of women with no prenatal chart. Dietetic treatment was calculated according to height, weeks of gestation, and weight, considering an energy intake of 30 kcal/kg of ideal weight and a macronutrient distribution of: 55-65% carbohydrates, 10-20% fat, and the remainder as proteins. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Evidence of the effect of Body Mass Index (BMI) on the methylation status of the PPAR gamma promoter region (-351 to -260).
Časové okno: Pregnant women were followed until delivery.
|
The treatment of DNA (2 µg) was performed with sodium bisulfite (EZ DNA Methylation-Direct Kit, ZymoResearch). For the control group, we used purified human methylated and unmethylated DNA (Zymo Research) with specific oligonucleotides. Lymphocyte DNA from healthy donors was used as negative control, and methylated DNA "in vitro" with Sss I enzyme (New England Biolabs) was used as positive control for methylation. The methylated (M3) and unmethylated (U3) primers used were those proposed by Pancione et al. |
Pregnant women were followed until delivery.
|
Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Hugo Mendieta Zerón, PhD., Asociación Científica Latina A.C.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 05-06-2009
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