Assess whether InsuVital intake improves the postprandial glucose, insulin and C-peptide response
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
- Pregnancy, labour, delivery and postpartum conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
4 -h postprandial AUC for blood insulin, glucose and C-peptide after InsuVital
or control drink followed by breakfast at Day 1
Secondary outcome
4 -h postprandial AUC for blood insulin, glucose and C-peptide after InsuVital
or control drink followed by breakfast at Day 8
Changes from baseline in the mean daily postprandial capillary glucose
concentration (3xdaily) during the 7-day Insuvital/control intake period
Changes from baseline in the mean daily capillary glucose AUC (5x daily) during
the 7 day Insuvital/control drink intake period
Daily AUC and time above glucose upper limit (>7 mmol/l) for continuous glucose
measurements at day 2,3,4
Background summary
InsuVital a casein hydrolysate. stimulates insulin secretion and decreases
postprandial glucose levels in patients with type 2 diabetes. InsuVital may fit
well in a set of dietary recommendations to manage blood glucose levels, which
are typically given in gestational diabetes. As yet no data are available about
the effect of insuVital in women with gestational diabetes.
Study objective
Assess whether InsuVital intake improves the postprandial glucose, insulin and
C-peptide response
Study design
Double-blind randomized parallel design
Intervention
25 women will receive 2 dd (before breakfast and dinner) an InsuVital drink
and 25 women will receive 2dd (before breakfast and dinner) a control drink
Study burden and risks
The study takes 8 days. The patient will consume 250 ml InsuVital or 250 ml
control drink twice daily. Subjects will daily fill in a Food Diary. Daily they
will determine a blood glucose curve (five measurements). At day 1 and 8 they
will visit the hospital for a four hour measurement period. They will report
fasted, receive a catheter into an antecubital vein for blood sampling. In
total, 14 x 6.5 ml =91 ml of blood will be sampled over a 4-h period both at
day 1 and day 8. After a fasting baseline sample is drawn, subjects will start
at t=0 consuming the InsuVital or control drink followed by a standardized
breakfast.
The subjects will be asked to wear a continuous glucose monitor for 4 days. The
latter is no condition to participate in the study
Dr. Molewaterplein 40
3015 GD
NL
Dr. Molewaterplein 40
3015 GD
NL
Listed location countries
Age
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
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 |
|---|---|
| CCMO | NL24605.078.08 |