Clinical trial NCT04856800: Pre-meal Consumption of Whey in Gestational Diabetes Mellitus From Diagnosis to Delivery
Official title: Pre-meal Consumption of Whey in Gestational Diabetes Mellitus From Diagnosis to Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Diabetes
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2021-04-23
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.


Eligibility criteria: Inclusion Criteria:

* GDM (OGTT level of blood glucose ≥ 9 mmol/L)
* Normal blood pressure
* Age \> 18 years

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Maternal glycemic variability (GV)
timeFrame: 24 hours
measure: Maternal glycemic variability (GV)
timeFrame: 24 hours
measure: Maternal glycemic variability (GV)
timeFrame: 24 hours
Secondary outcomes:
measure: 24 hours interstitial fluid glucose measures
timeFrame: 24 hours
measure: mean glucose
timeFrame: 24 hours
measure: maximum glucose
timeFrame: 24 hours
measure: Interstitial fluid glucose concentrations
timeFrame: 3 hours following breakfast
measure: Total energy expenditure
timeFrame: 24 hours
measure: Activity energy expenditure
timeFrame: 24 hours
measure: Activity count
timeFrame: 24 hours
measure: Heart rate
timeFrame: 24 hours
measure: Resting energy expenditure (REE) (Resting Metabolic Rate)
timeFrame: Performed for 20 minutes
measure: Respiratory quotient (RQ)
timeFrame: Performed for 20 minutes
measure: Oxidation rates of lipid, carbohydrate and protein
timeFrame: Performed for 20 minutes
measure: Diet diary
timeFrame: 24 hours
measure: Self-reported appetite
timeFrame: 3,5 hours following intake of whey/placebo at diagnosis, week 32 and week 36
measure: Body Mass Index
timeFrame: at diagnosis, week 32 and week 36
measure: Gestational weight change
timeFrame: at diagnosis, week 32 and week 36
measure: Medications
timeFrame: from diagnosis to delivery
measure: Pregnancy data
timeFrame: from diagnosis to delivery
measure: Delivery data
timeFrame: at delivery
measure: Non-targeted metabolomics will be performed on a sample of breast milk using Nuclear Magnetic Resonance
timeFrame: Day 1 postpartum
measure: Blood pressure
timeFrame: at diagnosis, week 32 and week 36
measure: Concentration differences in Insulin like growth factor I (IGF-1) (mother)
timeFrame: at diagnosis, week 32 and week 36
measure: Concentration differences in IGF-binding protein 3 (IGFBP-3) (mother)
timeFrame: at diagnosis, week 32 and week 36
measure: Concentration differences in IGF-binding protein 1 (IGFBP-1) (mother)
timeFrame: at diagnosis, week 32 and week 36
measure: Concentration differences in FGF-21 (mother)
timeFrame: at diagnosis, week 32 and week 36
measure: Concentration differences in Leptin (mother)
timeFrame: at diagnosis, week 32 and week 36
measure: Concentration differences in Adiponectin (mother)
timeFrame: at diagnosis, week 32 and week 36
measure: Concentration differences in CRP (mother)
timeFrame: at diagnosis, week 32 and week 36
measure: Concentration differences in Prolactin (mother)
timeFrame: at diagnosis, week 32 and week 36
measure: Concentration differences in Cortisol (mother)
timeFrame: at diagnosis, week 32 and week 36
measure: Concentration differences in Insulin (mother)
timeFrame: at diagnosis, week 32 and week 36
measure: Concentration differences in Free Fatty Acids (mother)
timeFrame: at diagnosis, week 32 and week 36
measure: Concentration differences in lactate (mother)
timeFrame: at diagnosis, week 32 and week 36
measure: Concentration differences in grehlin (mother)
timeFrame: at diagnosis, week 32 and week 36
measure: Concentration differences in inflammatory markers (IL-6, IL-10, IL-1α, IFN-γ, TNF-α)(mother)
timeFrame: at diagnosis, week 32 and week 36
measure: Concentration differences in glucose independent peptide (GIP) (mother)
timeFrame: at diagnosis, week 32 and week 36
measure: Concentration differences in glucagon like peptide 1 (GLP-1) (mother)
timeFrame: at diagnosis, week 32 and week 36
measure: Concentration differences in glucagon (mother)
timeFrame: at diagnosis, week 32 and week 36
measure: Concentration differences in c-peptide (mother)
timeFrame: at diagnosis, week 32 and week 36
measure: Concentration differences in amino acids (AA) (mother)
timeFrame: at diagnosis, week 32 and week 36
measure: Concentration differences in progesterone (mother)
timeFrame: at diagnosis, week 32 and week 36
measure: Concentration differences in steroid hormone binding protein (SHBP) (mother)
timeFrame: at diagnosis, week 32 and week 36
measure: Concentration differences in carboxy-terminal collagen crosslinks (CTx) (mother)
timeFrame: at diagnosis, week 32 and week 36
measure: Concentration differences in osteocalcin (OCN) (mother)
timeFrame: at diagnosis, week 32 and week 36
measure: Concentration differences in Pro-collagen I, N-term. pro-peptide (PINP) (mother)
timeFrame: at diagnosis, week 32 and week 36
measure: Concentration differences in Human chorionic gonadotropin (HCG) (mother)
timeFrame: at diagnosis, week 32 and week 36
measure: Concentration differences in CD163 (mother)
timeFrame: at diagnosis, week 32 and week 36
measure: Concentration differences in estradiol (mother)
timeFrame: at diagnosis, week 32 and week 36
measure: Concentration differences in hb1ac (mother)
timeFrame: at diagnosis, week 32 and week 36
measure: Concentration differences in lipids (cholesterol, triglyceride) (mother)
timeFrame: at diagnosis, week 32 and week 36
measure: Concentration differences in Insulin (cord blood, offspring)
timeFrame: at delivery
measure: Concentration differences in c-peptide (cord blood, offspring)
timeFrame: at delivery
measure: Concentration differences in glucagon (cord blood, offspring)
timeFrame: at delivery
measure: Concentration differences in glucose (cord blood, offspring)
timeFrame: at delivery
measure: Concentration differences in lactate (cord blood, offspring)
timeFrame: at delivery
measure: Differences in pH (cord blood, offspring)
timeFrame: at delivery
measure: non-targeted metabolomics analysis (cord blood, offspring)
timeFrame: at delivery
measure: DNA methylations measured with 850K-Illumina Infinium assay.
timeFrame: at delivery
measure: RNA-Seq transcriptome profiling
timeFrame: at delivery
measure: Body fat (offspring)
timeFrame: at delivery
measure: Birth weight (offspring)
timeFrame: at delivery
measure: Head circumference (offspring)
timeFrame: at delivery
measure: abdominal circumference (offspring)
timeFrame: at delivery
measure: Length (offspring)
timeFrame: at delivery
measure: Number of infants with icterus
timeFrame: through hospital admission immediately after delivery
measure: Apgar-score
timeFrame: at delivery
measure: number of patients needing early feeding
timeFrame: through hospital admission immediately after delivery
measure: Number of days admitted immediately after delivery
timeFrame: through hospital admission immediately after delivery
measure: Number of infants with hypoglycemia
timeFrame: at delivery
measure: Weight of placenta
timeFrame: at delivery
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Medicinsk forskningslaboratorium for Diabetes og Hormonsygdomme og Steno Diabetes Center Aarhus (M-lab), Aarhus universitetshospital
Study officials:
References: