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הניסוי הקליני NCT04856800 עבור סוכרת הריונית הוא הושלם. לכל הפרטים, עיינו בתצוגת הכרטיסים של רדאר ניסויים קליניים ובכלי הגילוי של AI. אפשר גם לשאול כל דבר כאן. | ||
מחקר אחד תואם לקריטריוני המסנן
תצוגת כרטיסים
חזרה לחיפוש
אוניברסיטת אורהוסPre-meal Consumption of Whey in Gestational Diabetes Mellitus From Diagnosis to Delivery 48 מהבית
פרטי הניסויים הקליניים זמינים בעיקר באנגלית. רדאר קליני AI יכול לעזור! לחץ על 'הסבר את המחקר' כדי לצפות ולשוחח על מידע מהמחקר בשפה המועדפת עליך.
הניסוי הקליני NCT04856800 היה מחקר מסוג התערבותי עבור סוכרת הריונית, שכעת הושלם. המחקר התחיל ב-1 בדצמבר 2021 ותוכנן לכלול 48 משתתפים. המחקר נוהל על ידי אוניברסיטת אורהוס ותאריך הסיום היה 31 באוקטובר 2023. מידע זה עודכן לאחרונה באתר ClinicalTrials.gov ב-12 בדצמבר 2023.
סיכום קצר
The main objective of the study is to investigate the metabolic effects of whey protein (whey protein isolate, WPI, (Lacprodan® ISO.Water. from Arla Foods Ingredients) compared with placebo when consumed by women with gestational diabetes mellitus (GDM) from diagnosis (around gestational week 28) to delivery. Any changes in substrate metabolism and energy expenditure using indirect calorimetry will also be investigat...הצג עוד
כותרת רשמית
Pre-meal Consumption of Whey in Gestational Diabetes Mellitus From Diagnosis to Delivery
מצבים רפואיים
סוכרת הריוניתמזהי מחקר נוספים
- 1-10-72-326-20
מספר NCT
תחילת המחקר (בפועל)
2021-12-01
עדכון אחרון שפורסם
2023-12-12
סיום המחקר (מוערך)
2023-10-31
משתתפים (מתוכנן)
48
סוג המחקר
התערבותי
שלב
לא ישים
סטטוס
הושלם
מטרה ראשית
טיפול
הקצאת טיפול
אקראי
דגם מתערב
קבוצות מקבילות
עיוורון
מרובע
זרועות / התערבויות
| קבוצת משתתפים/זרוע | התערבות/טיפול |
|---|---|
ניסיWhey Whey protein isolate WPI (Lacprodan® ISO.Water. from Arla Foods Ingredients). 20 g of whey protein will be ingested 30 min. prior to breakfast from diagnosis of GDM (around week 28) and until delivery. | Whey 20 g protein of whey protein isolate WPI (Lacprodan® ISO.Water. from Arla Foods Ingredients) |
פלצבו להשוואהPlacebo The placebo will be ingested 30 min. prior to breakfast from diagnosis of GDM (around week 28) and until delivery. | פלצבו The placebo contains \<1 kcal and 0 g protein |
מדדי תוצאה ראשיים
מדדי תוצאה משניים
| מדד תוצאה | תיאור המדידה | טווח זמן |
|---|---|---|
Maternal glycemic variability (GV) | The Coefficient of Variation, power: n = 50 | 24 hours |
Maternal glycemic variability (GV) | Interquartile range (IQR), power n = 40 | 24 hours |
Maternal glycemic variability (GV) | Standard deviation (SD), power n = 18 | 24 hours |
| מדד תוצאה | תיאור המדידה | טווח זמן |
|---|---|---|
24 hours interstitial fluid glucose measures | Continuous glucose monitoring | 24 hours |
mean glucose | Continuous glucose monitoring | 24 hours |
maximum glucose | Continuous glucose monitoring | 24 hours |
Interstitial fluid glucose concentrations | Continuous glucose monitoring | 3 hours following breakfast |
Total energy expenditure | Measured with a combined accelerometer and heart rate monitor, reported in kcal | 24 hours |
Activity energy expenditure | Measured with a combined accelerometer and heart rate monitor, reported in kcal | 24 hours |
Activity count | Measured with a combined accelerometer and heart rate monitor, reported in counts | 24 hours |
Heart rate | Measured with a combined accelerometer and heart rate monitor, reported in beats per minute | 24 hours |
Resting energy expenditure (REE) (Resting Metabolic Rate) | Indirect calorimetry | Performed for 20 minutes |
Respiratory quotient (RQ) | Indirect calorimetry | Performed for 20 minutes |
Oxidation rates of lipid, carbohydrate and protein | Indirect calorimetry | Performed for 20 minutes |
Diet diary | Total energy intake, composition of macronutrients | 24 hours |
Self-reported appetite | Questionnaire: A numerical rating scale ranging from "not at all = 0" to "extremely = 10" will be used to assess Hunger, Fullness, Satiety, Desire, Prospective consumption (Quantity). | 3,5 hours following intake of whey/placebo at diagnosis, week 32 and week 36 |
Body Mass Index | weight and height will be combined to report BMI in kg/m\^2 | at diagnosis, week 32 and week 36 |
Gestational weight change | at diagnosis, week 32 and week 36 | |
Medications | number of participants prescribed insulin, dose of insulin, time to insulin. Methyldopa, nifidipin or labetalol (medication to lower blood pressure) | from diagnosis to delivery |
Pregnancy data | Number of participants with hypertension, preeclampsia, maternal weight gain | from diagnosis to delivery |
Delivery data | Number of patients with cesarean section, shoulder dystocia, induction of labour | at delivery |
Non-targeted metabolomics will be performed on a sample of breast milk using Nuclear Magnetic Resonance | Analysis generating metabolites from pathways on amino acids, peptides, carbohydrates and lipids measured in folds increase/decrease when comparing placebo with whey | Day 1 postpartum |
Blood pressure | Systolic and diastolic blood pressure | at diagnosis, week 32 and week 36 |
Concentration differences in Insulin like growth factor I (IGF-1) (mother) | at diagnosis, week 32 and week 36 | |
Concentration differences in IGF-binding protein 3 (IGFBP-3) (mother) | at diagnosis, week 32 and week 36 | |
Concentration differences in IGF-binding protein 1 (IGFBP-1) (mother) | at diagnosis, week 32 and week 36 | |
Concentration differences in FGF-21 (mother) | at diagnosis, week 32 and week 36 | |
Concentration differences in Leptin (mother) | at diagnosis, week 32 and week 36 | |
Concentration differences in Adiponectin (mother) | at diagnosis, week 32 and week 36 | |
Concentration differences in CRP (mother) | at diagnosis, week 32 and week 36 | |
Concentration differences in Prolactin (mother) | at diagnosis, week 32 and week 36 | |
Concentration differences in Cortisol (mother) | at diagnosis, week 32 and week 36 | |
Concentration differences in Insulin (mother) | at diagnosis, week 32 and week 36 | |
Concentration differences in Free Fatty Acids (mother) | at diagnosis, week 32 and week 36 | |
Concentration differences in lactate (mother) | at diagnosis, week 32 and week 36 | |
Concentration differences in grehlin (mother) | at diagnosis, week 32 and week 36 | |
Concentration differences in inflammatory markers (IL-6, IL-10, IL-1α, IFN-γ, TNF-α)(mother) | at diagnosis, week 32 and week 36 | |
Concentration differences in glucose independent peptide (GIP) (mother) | at diagnosis, week 32 and week 36 | |
Concentration differences in glucagon like peptide 1 (GLP-1) (mother) | at diagnosis, week 32 and week 36 | |
Concentration differences in glucagon (mother) | at diagnosis, week 32 and week 36 | |
Concentration differences in c-peptide (mother) | at diagnosis, week 32 and week 36 | |
Concentration differences in amino acids (AA) (mother) | at diagnosis, week 32 and week 36 | |
Concentration differences in progesterone (mother) | at diagnosis, week 32 and week 36 | |
Concentration differences in steroid hormone binding protein (SHBP) (mother) | at diagnosis, week 32 and week 36 | |
Concentration differences in carboxy-terminal collagen crosslinks (CTx) (mother) | at diagnosis, week 32 and week 36 | |
Concentration differences in osteocalcin (OCN) (mother) | at diagnosis, week 32 and week 36 | |
Concentration differences in Pro-collagen I, N-term. pro-peptide (PINP) (mother) | at diagnosis, week 32 and week 36 | |
Concentration differences in Human chorionic gonadotropin (HCG) (mother) | at diagnosis, week 32 and week 36 | |
Concentration differences in CD163 (mother) | at diagnosis, week 32 and week 36 | |
Concentration differences in estradiol (mother) | at diagnosis, week 32 and week 36 | |
Concentration differences in hb1ac (mother) | at diagnosis, week 32 and week 36 | |
Concentration differences in lipids (cholesterol, triglyceride) (mother) | at diagnosis, week 32 and week 36 | |
Concentration differences in Insulin (cord blood, offspring) | at delivery | |
Concentration differences in c-peptide (cord blood, offspring) | at delivery | |
Concentration differences in glucagon (cord blood, offspring) | at delivery | |
Concentration differences in glucose (cord blood, offspring) | at delivery | |
Concentration differences in lactate (cord blood, offspring) | at delivery | |
Differences in pH (cord blood, offspring) | Measurement of acidity of the blood. Standard measurement performed on a sample of cord blood when a baby is delivered to evaluate possible oxygen deficiency during delivery. | at delivery |
non-targeted metabolomics analysis (cord blood, offspring) | Analysis generating metabolites from pathways on amino acids, peptides, carbohydrates, lipids and energy measured in folds rise/fall in when comparing placebo with whey | at delivery |
DNA methylations measured with 850K-Illumina Infinium assay. | Differentially methylated sites or regions associated with the intervention will be assessed. | at delivery |
RNA-Seq transcriptome profiling | Up and down-regulated genes associated with the intervention will be assessed | at delivery |
Body fat (offspring) | Sum of skinfolds measured with a caliper | at delivery |
Birth weight (offspring) | at delivery | |
Head circumference (offspring) | at delivery | |
abdominal circumference (offspring) | at delivery | |
Length (offspring) | at delivery | |
Number of infants with icterus | through hospital admission immediately after delivery | |
Apgar-score | Apgar score, range from 0-10, with the higher score the better outcome. | at delivery |
number of patients needing early feeding | through hospital admission immediately after delivery | |
Number of days admitted immediately after delivery | through hospital admission immediately after delivery | |
Number of infants with hypoglycemia | at delivery | |
Weight of placenta | at delivery |
קריטריוני זכאות
גילאים מוערכים למחקר
מבוגר, גיל שלישי
גיל מינימלי למחקר
18 Years
מגדרים מוערכים למחקר
נקבה
- GDM (OGTT level of blood glucose ≥ 9 mmol/L)
- Normal blood pressure
- Age > 18 years
- Special dietary regimes > 1 month at time of inclusion e.g. ketogenic diet
- Daily intake of protein supplements
- Milk allergy or phenylketonuria
- Medication with effect on glucose metabolism e.g. steroids
- Do not speak or understand Danish
- Twin pregnancy
- PCOS
- PI finds the patient unfit (like mental illness, too nervous or other)
- Severe chronic illness
- Severe nausea/vomiting
- Non-breakfast eaters
- Celiac disease
The initiation of insulin treatment during the trial will not lead to exclusion from the trial.
אוניברסיטת אורהוס305 מחקרים פעילים לחקוראין נתוני קשר.
1 מיקומי המחקר ב-1 מדינות
Medicinsk forskningslaboratorium for Diabetes og Hormonsygdomme og Steno Diabetes Center Aarhus (M-lab), Aarhus universitetshospital, Aarhus, Denmark