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Clinical Trial NCT04856800 for Gestational Diabetes is completed. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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University of AarhusPre-meal Consumption of Whey in Gestational Diabetes Mellitus From Diagnosis to Delivery 48 At-Home
Clinical Trial NCT04856800 was an interventional study for Gestational Diabetes that is now completed. The study started on 1 December 2021, with plans to enroll 48 participants. Led by University of Aarhus, the expected completion date was 31 October 2023. The latest data from ClinicalTrials.gov was last updated on 12 December 2023.
Brief Summary
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...Show More
Official Title
Pre-meal Consumption of Whey in Gestational Diabetes Mellitus From Diagnosis to Delivery
Conditions
Gestational DiabetesOther Study IDs
- 1-10-72-326-20
NCT ID Number
Start Date (Actual)
2021-12-01
Last Update Posted
2023-12-12
Completion Date (Estimated)
2023-10-31
Enrollment (Estimated)
48
Study Type
Interventional
PHASE
N/A
Status
Completed
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Quadruple
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalWhey 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) |
Placebo ComparatorPlacebo The placebo will be ingested 30 min. prior to breakfast from diagnosis of GDM (around week 28) and until delivery. | Placebo The placebo contains \<1 kcal and 0 g protein |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
Female
- 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.
University of Aarhus305 active studies to exploreNo contact data.
1 Study Locations in 1 Countries
Medicinsk forskningslaboratorium for Diabetes og Hormonsygdomme og Steno Diabetes Center Aarhus (M-lab), Aarhus universitetshospital, Aarhus, Denmark