Effect of Low Glycemic Index on Gestational Diabetes Mellitus — MyLGI  

Gestational Diabetes Mellitus Clinical Trial

Official title: Investigating the Effectiveness of a Low Glycemic Index on Glycemic Control and Pregnancy Outcomes in Women With Gestational Diabetes Mellitus: A Randomised Controlled Trial

Status Completed

Clinical Trial Summary

The purpose of this study is to determine whether glycemic index is effective in the treatment of maternal glycemia and pregnancy outcomes in women with Gestational Diabetes Mellitus.

Clinical Trial Description

1. This research is divided into 2, that are study I and study II

1. Study I, is to determine the long-term effects of intervention (low GI and SNT) on maternal glycemia, pregnancy outcomes and postprandial metabolic markers in women with GDM

• A total of 110 women with confirmed diagnosis of GDM will be recruited

• They will be randomized either to receive low GI (n=55) or Standard Nutrition Therapy (SNT; n=55)

• The intervention will be started as soon as the women being diagnosed with GDM and they will be followed-up every month until delivery and up to the 3-month postpartum.

• The primary outcome measures include glycemic control parameters as assessed by fasting and postprandial glycemia, fructosamine, HbA1c, insulin level and requirement for insulin treatment.

• Secondary outcomes include lipid profile, weight gain, measures of postprandial metabolic response (free fatty acid and triglyceride), pregnancy outcomes, and overall improvement in postpartum metabolic parameters.

2. Study II, a sub-Mixed-meal Tolerant Test (MTT) study will be conducted to determine postprandial glycemic and metabolic responses before and after 4-weeks of intensive intervention

• During the 4-weeks of intensive intervention, the subjects will receive individualise counseling and daily food supply regarding the allocated study group.

• A minimum of 19 subjects from a pool of 110 subjects who is participated in the intervention study will be recruited.

• The MTT procedure is similar to the oral glucose tolerant test (OGTT) but the subject will be asked to consume the real mixed meals representing low and high GI foods rather than oral glucose solution.

• Subject will be asked to consume the test meal (either low or high GI foods) and the blood will be sampled before and after consuming the test meal in two different occasions with 1-week wash-out period.

• After one month of intensive intervention, 19 subjects from each arm will undergo the final HGI meal tolerant test (MTT3) and the same procedure of MTT 1 and 2

• Approximately 32μl of capillary blood by finger-prick will be obtained 7 times per MTT session, which is every 30 minutes thereafter to complete 3-h postprandial meal for each set of meal tests. ;

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes Mellitus

• NCT number: NCT03801824
• Study type: Interventional
• Source: Universiti Putra Malaysia
• Status: Completed
• Phase: N/A
• Start date: April 2014
• Completion date: September 2016