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奥胡斯大学Pre-meal Consumption of Whey in Gestational Diabetes Mellitus From Diagnosis to Delivery 48 居家
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临床试验NCT04856800是一项针对妊娠糖尿病的干预性研究试验，试验状态为已完成。试验开始于2021年12月1日，共计划招募48名患者。该研究由奥胡斯大学主导，已于2023年10月31日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2023年12月12日。
简要概括
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...显示更多
官方标题
Pre-meal Consumption of Whey in Gestational Diabetes Mellitus From Diagnosis to Delivery
疾病
妊娠糖尿病其他研究标识符
- 1-10-72-326-20
NCT编号
实际开始日期
2021-12-01
最近更新发布
2023-12-12
预计完成日期
2023-10-31
计划入组人数
48
研究类型
干预性研究
试验分期 (阶段)
不适用
试验状态
已完成
主要目的
治疗方法
分配方式
随机
干预模型
平行
盲法
四盲
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
实验性Whey 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) |
安慰剂对照Placebo The placebo will be ingested 30 min. prior to breakfast from diagnosis of GDM (around week 28) and until delivery. | 安慰剂 The placebo contains \<1 kcal and 0 g protein |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
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 |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
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 |
资格标准
适龄参与研究
成人, 老年人
最低年龄要求
18 Years
适龄性别
女性
- 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.
奥胡斯大学305 个活跃的临床试验可供探索没有联系数据。
1 位于 1 个国家/地区的研究中心
Medicinsk forskningslaboratorium for Diabetes og Hormonsygdomme og Steno Diabetes Center Aarhus (M-lab), Aarhus universitetshospital, Aarhus, Denmark