Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-25 @ 9:30 PM
Study NCT ID:
NCT02225951
Status:
TERMINATED
Last Update Posted:
2017-09-07
First Post:
2014-08-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Meal Tolerance Trial in Pregnant Women Diagnosed With Gestational Diabetes Mellitus.
Sponsor:
Danone Asia Pacific Holdings Pte, Ltd.
Organization:
Study Overview
Official Title:
A Randomised, Controlled, Open-label Trial to Investigate the Effect of a New Nutritional Supplement on Postprandial Glucose Response in Women Diagnosed With Gestational Diabetes Mellitus.
Status:
TERMINATED
Status Verified Date:
2017-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Current protocol is not optimal/feasible
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GDM-MTT
Brief Summary:
This study is initiated to investigate the effect of a nutritional product on the 3-hr postprandial glucose response compared to a control standard breakfast at baseline and after 4 weeks of intervention.
Detailed Description:
The primary objective of the study is to investigate the effect of study product on the 3-hour postprandial glucose response compared to a controlled standard breakfast at baseline and after 4 weeks of intervention. Secondary objectives include investigation on the effect of the product compared to a control standard breakfast to the 3-hr postprandial insulin response, postprandial peak and delta peak concentration of glucose and insulin, fasting concentration of glucose and insulin, and insulin resistance as calculated by the HOMA index. The study also aims to measure compliance, study product intake and appreciation, safety and tolerance to study product, as well as satiety, daily energy and nutrient intake.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: