search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Effect of protein hydrolysate on blood glucose control in women with gestational diabetes.


- candidate number5910
- NTR NumberNTR1848
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR9-jun-2009
- Secondary IDs062374 METC Erasmus
- Public TitleEffect of protein hydrolysate on blood glucose control in women with gestational diabetes.
- Scientific TitleEffect of protein hydrolysate on blood glucose control in women with gestational diabetes.
- ACRONYMN/A
- hypothesisThe protein hydrolysate reduces the postprandial glucose response and increases the insulin and C-peptide response in women with gestational diabetes mellitus.
- Healt Condition(s) or Problem(s) studiedGestational diabetes
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jul-2009
- planned closingdate1-dec-2010
- Target number of participants50
- InterventionsWomen 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., 7 days), one before breakfast and one before dinner.
- Primary outcome4 -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 outcome1. 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.
- Timepoints1. Baseline;
2. 7 day intervention.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. Willy Visser
- CONTACT for SCIENTIFIC QUERIESProf. Dr. E.A.P. Steegers
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Erasmus Medical Center, DSM Food Specialties
- PublicationsN/A
- Brief summaryThis study is designed to assess whether protein hydrolysate intake improves the postprandial glucose, insulin and C-peptide response in women with gestational diabetes.
- Main changes (audit trail)
- RECORD9-jun-2009 - 30-sep-2009


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl