Effect of InsuVital on glucose control in women with gestational diabetes

Recruiting

• Conditions: Gestational Diabetes; 10018424; 10010273

• Registration Number: NL-OMON33906
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

Women with gestational diabetes
Gestational age >= 20wks and <36wks

Exclusion Criteria

Diabetes type 1 or type 2
3 times plasma glucose > 9 mmol/l or once plasma glucose > 11 mmol/l
GFR < 60 mL/min/1.73 m2
ALAT > 70 IU/L

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>4 -h postprandial AUC for blood insulin, glucose and C-peptide after InsuVital<br /><br>or control drink followed by breakfast at Day 1</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>4 -h postprandial AUC for blood insulin, glucose and C-peptide after InsuVital<br /><br>or control drink followed by breakfast at Day 8<br /><br>Changes from baseline in the mean daily postprandial capillary glucose<br /><br>concentration (3xdaily) during the 7-day Insuvital/control intake period<br /><br>Changes from baseline in the mean daily capillary glucose AUC (5x daily) during<br /><br>the 7 day Insuvital/control drink intake period<br /><br>Daily AUC and time above glucose upper limit (>7 mmol/l) for continuous glucose<br /><br>measurements at day 2,3,4</p><br>