Effect of Low Glycemic Index on Gestational Diabetes Mellitus
Condition: Gestational Diabetes Mellitus
MeSH terms: Diabetes, Gestational; Diabetes Mellitus
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): Standard Nutrition Therapy; Low Glycemic Index
Intervention type(s): Other; Other
Intervention description(s): Subjects will be advised on standard diet appropriate for the management of Gestational Diabetes Mellitus (GDM) designed to be high in fiber and have moderate to high dietary glycemic index; Subjects will be advised to eat low glycemic index foods
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Gestational Diabetes Mellitus; Glycemic index; Metabolic Response; Pregnancy Outcomes; Glycemic control