NCT04856800已完成不适用
Pre-meal Consumption of Whey in Gestational Diabetes Mellitus From Diagnosis to Delivery
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Maternal glycemic variability (GV)
研究概览
简要总结
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 investigated. Differences in hunger and satiety parameters as well as blood pressure and gestational weight gain will also be assessed. Furthermore, analysis on the glucose response when the women consume the intervention (whey or placebo) at home in their own environment 30 minutes before breakfast at time of diagnosis (earliest week 28) and week 36 (four days following each time point) will be made. The women will be monitored with continuous glucose monitors, activity monitors and all meals will be provided for two days following the study days in the laboratory. At delivery cord blood will be sampled for analysis on metabolic parameters and investigations on epigenetics/DNA methylations. Complications to the delivery, neonatal outcomes, anthropometrics of the child will also be assessed. Breast milk composition will also be analyzed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •GDM (OGTT level of blood glucose ≥ 9 mmol/L)
- •Normal blood pressure
- •Age > 18 years
排除标准
- •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
- •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.
结局指标
主要结局
Maternal glycemic variability (GV)
时间窗: 24 hours
The Coefficient of Variation, power: n = 50
次要结局
- Number of infants with hypoglycemia(at delivery)
- Weight of placenta(at delivery)
- mean glucose(24 hours)
- maximum glucose(24 hours)
- 24 hours interstitial fluid glucose measures(24 hours)
- Oxidation rates of lipid, carbohydrate and protein(Performed for 20 minutes)
- Concentration differences in CD163 (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 estradiol (mother)(at diagnosis, week 32 and week 36)
- Concentration differences in Insulin (cord blood, offspring)(at delivery)
- non-targeted metabolomics analysis (cord blood, offspring)(at delivery)
- Concentration differences in hb1ac (mother)(at diagnosis, week 32 and week 36)
- Concentration differences in c-peptide (cord blood, offspring)(at delivery)
- Concentration differences in glucagon (cord blood, offspring)(at delivery)
- DNA methylations measured with 850K-Illumina Infinium assay.(at delivery)
- RNA-Seq transcriptome profiling(at delivery)
- Differences in pH (cord blood, offspring)(at delivery)
- Body fat (offspring)(at delivery)
- Interstitial fluid glucose concentrations(3 hours following breakfast)
- Heart rate(24 hours)
- Gestational weight change(at diagnosis, week 32 and week 36)
- Medications(from diagnosis to delivery)
- Concentration differences in Leptin (mother)(at diagnosis, week 32 and week 36)
- Concentration differences in Adiponectin (mother)(at diagnosis, week 32 and week 36)
- Self-reported appetite(3,5 hours following intake of whey/placebo 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 FGF-21 (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 Free Fatty Acids (mother)(at diagnosis, week 32 and week 36)
- Total energy expenditure(24 hours)
- Activity energy expenditure(24 hours)
- Activity count(24 hours)
- Respiratory quotient (RQ)(Performed for 20 minutes)
- Diet diary(24 hours)
- Birth weight (offspring)(at delivery)
- Pregnancy data(from diagnosis to delivery)
- Delivery data(at delivery)
- Non-targeted metabolomics will be performed on a sample of breast milk using Nuclear Magnetic Resonance(Day 1 postpartum)
- abdominal circumference (offspring)(at delivery)
- Number of infants with icterus(through hospital admission immediately after delivery)
- Concentration differences in IGF-binding protein 1 (IGFBP-1) (mother)(at diagnosis, week 32 and week 36)
- Apgar-score(at delivery)
- 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 Insulin (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 c-peptide (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 (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 osteocalcin (OCN) (mother)(at diagnosis, week 32 and week 36)
- Concentration differences in progesterone (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 glucose (cord blood, offspring)(at delivery)
- Concentration differences in lactate (cord blood, offspring)(at delivery)
- Head circumference (offspring)(at delivery)
- Length (offspring)(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)
- 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)
- Resting energy expenditure (REE) (Resting Metabolic Rate)(Performed for 20 minutes)
- Body Mass Index(at diagnosis, week 32 and week 36)
- Blood pressure(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 CRP (mother)(at diagnosis, week 32 and week 36)
研究者
研究点 (1)
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