Women with gestational diabetes mellitus.
Conditions
Interventions
Women will receive either a protein hydrolysate-containing drink or a control drink containing 8.5 g protein hydrolysate dissolved in water that will be consumed twice daily for in total 15 times (i.e
Sponsors
Erasmus Medical Center Rotterdam
Eligibility
Inclusion criteria
Inclusion criteria: 1. Gestational age >20 wks and <36 wks; 2. Positive plasma glucose screen or positive 75 g OGTT; 3. Singleton pregnancy; 4. Subject is willing to undergo all protocol related assessments; 5. Subject has read the information provided on the study and given written consent.
Exclusion criteria
Exclusion criteria: 1. 3 plasma glucose levels >9 mmol/L or 1 plasma glucose level >11 mmol/L after which subjects will start insulin treatment; 2. Diagnosed type-1 or type 2 diabetes; 3. Renal insufficiency (GFR 70 IU/L; 5. Anaemia (Hemoglobin level <7.0 mmol/l); 6. Any clinical condition or laboratory test result that in the opinion of the investigators may jeopardise the health status of the participants; 7. Subjects who are enrolled in an another intervention study or have received an intervention within the last 14 days prior to screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 4 -h postprandial Area Under the Curve (AUC) for blood insulin, glucose and C-peptide after protein hydrolysate or control drink followed by breakfast at Day 1. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. 4 -h postprandial AUC for blood insulin, glucose and C-peptide after protein hydrolysate or control drink followed by breakfast at Day 8; 2. Changes from baseline in the mean daily postprandial capillary glucose concentration (3xdaily) during the 7-day protein hydrolysate/control intake period; 3. Changes from baseline in the mean daily capillary glucose AUC (5x daily) during the 7 day protein hydrolysate/control drink intake period; 4. Daily AUC and time above glucose upper limit (>7 mmol/l) for continuous glucose measurements at day 2,3,4. | — |
Contacts
Public ContactWilly Visser
Dr Molewaterplein 60
Outcome results
None listed