Pre-meal Consumption of Whey in Gestational Diabetes Mellitus From Diagnosis to Delivery

Gestational Diabetes Clinical Trial

Official title:

Pre-meal Consumption of Whey in Gestational Diabetes Mellitus From Diagnosis to Delivery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04856800
• Other study ID #: 1-10-72-326-20
• Status: Completed
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: October 31, 2023

Study information

• Verified date: May 2022
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: October 31, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes

Intervention

Dietary Supplement:
• Whey
20 g protein of whey protein isolate WPI (Lacprodan® ISO.Water. from Arla Foods Ingredients)
• Placebo
The placebo contains <1 kcal and 0 g protein

Locations

Country	Name	City	State
Denmark	Medicinsk forskningslaboratorium for Diabetes og Hormonsygdomme og Steno Diabetes Center Aarhus (M-lab), Aarhus universitetshospital	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maternal glycemic variability (GV)	The Coefficient of Variation, power: n = 50	24 hours
Primary	Maternal glycemic variability (GV)	Interquartile range (IQR), power n = 40	24 hours
Primary	Maternal glycemic variability (GV)	Standard deviation (SD), power n = 18	24 hours
Secondary	24 hours interstitial fluid glucose measures	Continuous glucose monitoring	24 hours
Secondary	mean glucose	Continuous glucose monitoring	24 hours
Secondary	maximum glucose	Continuous glucose monitoring	24 hours
Secondary	Interstitial fluid glucose concentrations	Continuous glucose monitoring	3 hours following breakfast
Secondary	Total energy expenditure	Measured with a combined accelerometer and heart rate monitor, reported in kcal	24 hours
Secondary	Activity energy expenditure	Measured with a combined accelerometer and heart rate monitor, reported in kcal	24 hours
Secondary	Activity count	Measured with a combined accelerometer and heart rate monitor, reported in counts	24 hours
Secondary	Heart rate	Measured with a combined accelerometer and heart rate monitor, reported in beats per minute	24 hours
Secondary	Resting energy expenditure (REE) (Resting Metabolic Rate)	Indirect calorimetry	Performed for 20 minutes
Secondary	Respiratory quotient (RQ)	Indirect calorimetry	Performed for 20 minutes
Secondary	Oxidation rates of lipid, carbohydrate and protein	Indirect calorimetry	Performed for 20 minutes
Secondary	Diet diary	Total energy intake, composition of macronutrients	24 hours
Secondary	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
Secondary	Body Mass Index	weight and height will be combined to report BMI in kg/m^2	at diagnosis, week 32 and week 36
Secondary	Gestational weight change		at diagnosis, week 32 and week 36
Secondary	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
Secondary	Pregnancy data	Number of participants with hypertension, preeclampsia, maternal weight gain	from diagnosis to delivery
Secondary	Delivery data	Number of patients with cesarean section, shoulder dystocia, induction of labour	at delivery
Secondary	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
Secondary	Blood pressure	Systolic and diastolic blood pressure	at diagnosis, week 32 and week 36
Secondary	Concentration differences in Insulin like growth factor I (IGF-1) (mother)		at diagnosis, week 32 and week 36
Secondary	Concentration differences in IGF-binding protein 3 (IGFBP-3) (mother)		at diagnosis, week 32 and week 36
Secondary	Concentration differences in IGF-binding protein 1 (IGFBP-1) (mother)		at diagnosis, week 32 and week 36
Secondary	Concentration differences in FGF-21 (mother)		at diagnosis, week 32 and week 36
Secondary	Concentration differences in Leptin (mother)		at diagnosis, week 32 and week 36
Secondary	Concentration differences in Adiponectin (mother)		at diagnosis, week 32 and week 36
Secondary	Concentration differences in CRP (mother)		at diagnosis, week 32 and week 36
Secondary	Concentration differences in Prolactin (mother)		at diagnosis, week 32 and week 36
Secondary	Concentration differences in Cortisol (mother)		at diagnosis, week 32 and week 36
Secondary	Concentration differences in Insulin (mother)		at diagnosis, week 32 and week 36
Secondary	Concentration differences in Free Fatty Acids (mother)		at diagnosis, week 32 and week 36
Secondary	Concentration differences in lactate (mother)		at diagnosis, week 32 and week 36
Secondary	Concentration differences in grehlin (mother)		at diagnosis, week 32 and week 36
Secondary	Concentration differences in inflammatory markers (IL-6, IL-10, IL-1a, IFN-?, TNF-a)(mother)		at diagnosis, week 32 and week 36
Secondary	Concentration differences in glucose independent peptide (GIP) (mother)		at diagnosis, week 32 and week 36
Secondary	Concentration differences in glucagon like peptide 1 (GLP-1) (mother)		at diagnosis, week 32 and week 36
Secondary	Concentration differences in glucagon (mother)		at diagnosis, week 32 and week 36
Secondary	Concentration differences in c-peptide (mother)		at diagnosis, week 32 and week 36
Secondary	Concentration differences in amino acids (AA) (mother)		at diagnosis, week 32 and week 36
Secondary	Concentration differences in progesterone (mother)		at diagnosis, week 32 and week 36
Secondary	Concentration differences in steroid hormone binding protein (SHBP) (mother)		at diagnosis, week 32 and week 36
Secondary	Concentration differences in carboxy-terminal collagen crosslinks (CTx) (mother)		at diagnosis, week 32 and week 36
Secondary	Concentration differences in osteocalcin (OCN) (mother)		at diagnosis, week 32 and week 36
Secondary	Concentration differences in Pro-collagen I, N-term. pro-peptide (PINP) (mother)		at diagnosis, week 32 and week 36
Secondary	Concentration differences in Human chorionic gonadotropin (HCG) (mother)		at diagnosis, week 32 and week 36
Secondary	Concentration differences in CD163 (mother)		at diagnosis, week 32 and week 36
Secondary	Concentration differences in estradiol (mother)		at diagnosis, week 32 and week 36
Secondary	Concentration differences in hb1ac (mother)		at diagnosis, week 32 and week 36
Secondary	Concentration differences in lipids (cholesterol, triglyceride) (mother)		at diagnosis, week 32 and week 36
Secondary	Concentration differences in Insulin (cord blood, offspring)		at delivery
Secondary	Concentration differences in c-peptide (cord blood, offspring)		at delivery
Secondary	Concentration differences in glucagon (cord blood, offspring)		at delivery
Secondary	Concentration differences in glucose (cord blood, offspring)		at delivery
Secondary	Concentration differences in lactate (cord blood, offspring)		at delivery
Secondary	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
Secondary	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
Secondary	DNA methylations measured with 850K-Illumina Infinium assay.	Differentially methylated sites or regions associated with the intervention will be assessed.	at delivery
Secondary	RNA-Seq transcriptome profiling	Up and down-regulated genes associated with the intervention will be assessed	at delivery
Secondary	Body fat (offspring)	Sum of skinfolds measured with a caliper	at delivery
Secondary	Birth weight (offspring)		at delivery
Secondary	Head circumference (offspring)		at delivery
Secondary	abdominal circumference (offspring)		at delivery
Secondary	Length (offspring)		at delivery
Secondary	Number of infants with icterus		through hospital admission immediately after delivery
Secondary	Apgar-score	Apgar score, range from 0-10, with the higher score the better outcome.	at delivery
Secondary	number of patients needing early feeding		through hospital admission immediately after delivery
Secondary	Number of days admitted immediately after delivery		through hospital admission immediately after delivery
Secondary	Number of infants with hypoglycemia		at delivery
Secondary	Weight of placenta		at delivery