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Completed

NCT Number: NCT04856800

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

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.

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Key information

Conditions

Gestational Diabetes Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Medicinsk forskningslaboratorium for Diabetes og Hormonsygdomme og Steno Diabetes Center Aarhus (M-lab), Aarhus universitetshospital

Aarhus, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Whey

Dietary Supplement

20 g protein of whey protein isolate WPI (Lacprodan® ISO.Water. from Arla Foods Ingredients)

Placebo

Dietary Supplement

The placebo contains <1 kcal and 0 g protein

Primary outcomes

  1. Maternal glycemic variability (GV)

    Time frame: 24 hours

    The Coefficient of Variation, power: n = 50

  2. Maternal glycemic variability (GV)

    Time frame: 24 hours

    Interquartile range (IQR), power n = 40

  3. Maternal glycemic variability (GV)

    Time frame: 24 hours

    Standard deviation (SD), power n = 18

Secondary outcomes

  1. 24 hours interstitial fluid glucose measures

    Time frame: 24 hours

    Continuous glucose monitoring

  2. mean glucose

    Time frame: 24 hours

    Continuous glucose monitoring

  3. maximum glucose

    Time frame: 24 hours

    Continuous glucose monitoring

  4. Interstitial fluid glucose concentrations

    Time frame: 3 hours following breakfast

    Continuous glucose monitoring

  5. Total energy expenditure

    Time frame: 24 hours

    Measured with a combined accelerometer and heart rate monitor, reported in kcal

  6. Activity energy expenditure

    Time frame: 24 hours

    Measured with a combined accelerometer and heart rate monitor, reported in kcal

  7. Activity count

    Time frame: 24 hours

    Measured with a combined accelerometer and heart rate monitor, reported in counts

  8. Heart rate

    Time frame: 24 hours

    Measured with a combined accelerometer and heart rate monitor, reported in beats per minute

  9. Resting energy expenditure (REE) (Resting Metabolic Rate)

    Time frame: Performed for 20 minutes

    Indirect calorimetry

  10. Respiratory quotient (RQ)

    Time frame: Performed for 20 minutes

    Indirect calorimetry

  11. Oxidation rates of lipid, carbohydrate and protein

    Time frame: Performed for 20 minutes

    Indirect calorimetry

  12. Diet diary

    Time frame: 24 hours

    Total energy intake, composition of macronutrients

  13. Self-reported appetite

    Time frame: 3,5 hours following intake of whey/placebo at diagnosis, week 32 and week 36

    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).

  14. Body Mass Index

    Time frame: at diagnosis, week 32 and week 36

    weight and height will be combined to report BMI in kg/m^2

  15. Gestational weight change

    Time frame: at diagnosis, week 32 and week 36

  16. Medications

    Time frame: from diagnosis to delivery

    number of participants prescribed insulin, dose of insulin, time to insulin. Methyldopa, nifidipin or labetalol (medication to lower blood pressure)

  17. Pregnancy data

    Time frame: from diagnosis to delivery

    Number of participants with hypertension, preeclampsia, maternal weight gain

  18. Delivery data

    Time frame: at delivery

    Number of patients with cesarean section, shoulder dystocia, induction of labour

  19. Non-targeted metabolomics will be performed on a sample of breast milk using Nuclear Magnetic Resonance

    Time frame: Day 1 postpartum

    Analysis generating metabolites from pathways on amino acids, peptides, carbohydrates and lipids measured in folds increase/decrease when comparing placebo with whey

  20. Blood pressure

    Time frame: at diagnosis, week 32 and week 36

    Systolic and diastolic blood pressure

  21. Concentration differences in Insulin like growth factor I (IGF-1) (mother)

    Time frame: at diagnosis, week 32 and week 36

  22. Concentration differences in IGF-binding protein 3 (IGFBP-3) (mother)

    Time frame: at diagnosis, week 32 and week 36

  23. Concentration differences in IGF-binding protein 1 (IGFBP-1) (mother)

    Time frame: at diagnosis, week 32 and week 36

  24. Concentration differences in FGF-21 (mother)

    Time frame: at diagnosis, week 32 and week 36

  25. Concentration differences in Leptin (mother)

    Time frame: at diagnosis, week 32 and week 36

  26. Concentration differences in Adiponectin (mother)

    Time frame: at diagnosis, week 32 and week 36

  27. Concentration differences in CRP (mother)

    Time frame: at diagnosis, week 32 and week 36

  28. Concentration differences in Prolactin (mother)

    Time frame: at diagnosis, week 32 and week 36

  29. Concentration differences in Cortisol (mother)

    Time frame: at diagnosis, week 32 and week 36

  30. Concentration differences in Insulin (mother)

    Time frame: at diagnosis, week 32 and week 36

  31. Concentration differences in Free Fatty Acids (mother)

    Time frame: at diagnosis, week 32 and week 36

  32. Concentration differences in lactate (mother)

    Time frame: at diagnosis, week 32 and week 36

  33. Concentration differences in grehlin (mother)

    Time frame: at diagnosis, week 32 and week 36

  34. Concentration differences in inflammatory markers (IL-6, IL-10, IL-1α, IFN-γ, TNF-α)(mother)

    Time frame: at diagnosis, week 32 and week 36

  35. Concentration differences in glucose independent peptide (GIP) (mother)

    Time frame: at diagnosis, week 32 and week 36

  36. Concentration differences in glucagon like peptide 1 (GLP-1) (mother)

    Time frame: at diagnosis, week 32 and week 36

  37. Concentration differences in glucagon (mother)

    Time frame: at diagnosis, week 32 and week 36

  38. Concentration differences in c-peptide (mother)

    Time frame: at diagnosis, week 32 and week 36

  39. Concentration differences in amino acids (AA) (mother)

    Time frame: at diagnosis, week 32 and week 36

  40. Concentration differences in progesterone (mother)

    Time frame: at diagnosis, week 32 and week 36

  41. Concentration differences in steroid hormone binding protein (SHBP) (mother)

    Time frame: at diagnosis, week 32 and week 36

  42. Concentration differences in carboxy-terminal collagen crosslinks (CTx) (mother)

    Time frame: at diagnosis, week 32 and week 36

  43. Concentration differences in osteocalcin (OCN) (mother)

    Time frame: at diagnosis, week 32 and week 36

  44. Concentration differences in Pro-collagen I, N-term. pro-peptide (PINP) (mother)

    Time frame: at diagnosis, week 32 and week 36

  45. Concentration differences in Human chorionic gonadotropin (HCG) (mother)

    Time frame: at diagnosis, week 32 and week 36

  46. Concentration differences in CD163 (mother)

    Time frame: at diagnosis, week 32 and week 36

  47. Concentration differences in estradiol (mother)

    Time frame: at diagnosis, week 32 and week 36

  48. Concentration differences in hb1ac (mother)

    Time frame: at diagnosis, week 32 and week 36

  49. Concentration differences in lipids (cholesterol, triglyceride) (mother)

    Time frame: at diagnosis, week 32 and week 36

  50. Concentration differences in Insulin (cord blood, offspring)

    Time frame: at delivery

  51. Concentration differences in c-peptide (cord blood, offspring)

    Time frame: at delivery

  52. Concentration differences in glucagon (cord blood, offspring)

    Time frame: at delivery

  53. Concentration differences in glucose (cord blood, offspring)

    Time frame: at delivery

  54. Concentration differences in lactate (cord blood, offspring)

    Time frame: at delivery

  55. Differences in pH (cord blood, offspring)

    Time frame: at delivery

    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.

  56. non-targeted metabolomics analysis (cord blood, offspring)

    Time frame: at delivery

    Analysis generating metabolites from pathways on amino acids, peptides, carbohydrates, lipids and energy measured in folds rise/fall in when comparing placebo with whey

  57. DNA methylations measured with 850K-Illumina Infinium assay.

    Time frame: at delivery

    Differentially methylated sites or regions associated with the intervention will be assessed.

  58. RNA-Seq transcriptome profiling

    Time frame: at delivery

    Up and down-regulated genes associated with the intervention will be assessed

  59. Body fat (offspring)

    Time frame: at delivery

    Sum of skinfolds measured with a caliper

  60. Birth weight (offspring)

    Time frame: at delivery

  61. Head circumference (offspring)

    Time frame: at delivery

  62. abdominal circumference (offspring)

    Time frame: at delivery

  63. Length (offspring)

    Time frame: at delivery

  64. Number of infants with icterus

    Time frame: through hospital admission immediately after delivery

  65. Apgar-score

    Time frame: at delivery

    Apgar score, range from 0-10, with the higher score the better outcome.

  66. number of patients needing early feeding

    Time frame: through hospital admission immediately after delivery

  67. Number of days admitted immediately after delivery

    Time frame: through hospital admission immediately after delivery

  68. Number of infants with hypoglycemia

    Time frame: at delivery

  69. Weight of placenta

    Time frame: at delivery

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 23, 2021
Registry last updated
Dec 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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