Effect of protein hydrolysate on blood glucose control in women with gestational diabetes.
Recruiting
- Conditions
- Women with gestational diabetes mellitus.
- Registration Number
- NL-OMON23081
- Lead Sponsor
- Erasmus Medical Center Rotterdam
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 50
Inclusion Criteria
1. Gestational age >20 wks and <36 wks;
2. Positive plasma glucose screen or positive 75 g OGTT;
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;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method 1. 4 -h postprandial AUC for blood insulin, glucose and C-peptide after protein hydrolysate or control drink followed by breakfast at Day 8;<br /><br>2. Changes from baseline in the mean daily postprandial capillary glucose concentration (3xdaily) during the 7-day protein hydrolysate/control intake period;<br /><br>3. Changes from baseline in the mean daily capillary glucose AUC (5x daily) during the 7 day protein hydrolysate/control drink intake period;<br /><br>4. Daily AUC and time above glucose upper limit (>7 mmol/l) for continuous glucose measurements at day 2,3,4.