Effect of InsuVital on glucose control in women with gestational diabetes

Effect of InsuVital on glucose control in women with gestational diabetes - InsuVital in gestational diabetes

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON33906

Enrollment

Registered

2009-03-04

Start date

2009-11-01

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gestational Diabetes

Interventions

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

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Women with gestational diabetes Gestational age >= 20wks and

Exclusion criteria

Exclusion criteria: Diabetes type 1 or type 2 3 times plasma glucose > 9 mmol/l or once plasma glucose > 11 mmol/l GFR 70 IU/L

Design outcomes

Primary

Measure	Time frame
4 -h postprandial AUC for blood insulin, glucose and C-peptide after InsuVital or control drink followed by breakfast at Day 1	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)