No registrations found.
ID
Source
Brief title
Health condition
Women with gestational diabetes mellitus.
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
This study is designed to assess whether protein hydrolysate intake improves the postprandial glucose, insulin and C-peptide response in women with gestational diabetes.
Study objective
The protein hydrolysate reduces the postprandial glucose response and increases the insulin and C-peptide response in women with gestational diabetes mellitus.
Study design
1. Baseline;
2. 7½ day intervention.
Intervention
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., 7½ days), one before breakfast and one before dinner.
Willy Visser
Erasmus Medical Center Rotterdam Department of Obstetrics and Gynaecology
Rotterdam 3015 GD
The Netherlands
010-7036614
willy.visser@erasmusmc.nl
Willy Visser
Erasmus Medical Center Rotterdam Department of Obstetrics and Gynaecology
Rotterdam 3015 GD
The Netherlands
010-7036614
willy.visser@erasmusmc.nl
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
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 <60 mL/min/1.73 m2 according to MDRD formula= GFR (mL/min/1.73 m2=1.75 x (0.0113 x s-creat)-1,154 x (age)-0,203x (0.742 for women) multiplied by 1.21 if the patient is black/Afro-Caribbean);
4. Serum ALAT >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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL1738 |
| NTR-old | NTR1848 |
| Other | METC Erasmus : 062374 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |