The protein hydrolysate reduces the postprandial glucose response and increases the insulin and C-peptide response in women with gestational diabetes mellitus.
ID
Bron
Verkorte titel
Aandoening
Women with gestational diabetes mellitus.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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.
Achtergrond van het onderzoek
This study is designed to assess whether protein hydrolysate intake improves the postprandial glucose, insulin and C-peptide response in women with gestational diabetes.
Doel van het onderzoek
The protein hydrolysate reduces the postprandial glucose response and increases the insulin and C-peptide response in women with gestational diabetes mellitus.
Onderzoeksopzet
1. Baseline;
2. 7½ day intervention.
Onderzoeksproduct en/of interventie
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.
Publiek
Willy Visser
Erasmus Medical Center Rotterdam Department of Obstetrics and Gynaecology
Rotterdam 3015 GD
The Netherlands
010-7036614
willy.visser@erasmusmc.nl
Wetenschappelijk
Willy Visser
Erasmus Medical Center Rotterdam Department of Obstetrics and Gynaecology
Rotterdam 3015 GD
The Netherlands
010-7036614
willy.visser@erasmusmc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL1738 |
| NTR-old | NTR1848 |
| Ander register | METC Erasmus : 062374 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |