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Meal Tolerance Trial in Pregnant Women Diagnosed With Gestational Diabetes Mellitus. — GDM-MTT  

Gestational Diabetes Mellitus in Pregnancy Clinical Trial

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.

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02225951
Study type Interventional
Source Danone Asia Pacific Holdings Pte, Ltd.
Contact
Status Terminated
Phase N/A
Start date July 2014
Completion date September 2014
View Details
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