Effect of Low Glycemic Index on Gestational Diabetes Mellitus

Study Overview
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Brief Summary
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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
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1. This research is divided into 2, that are study I and study II 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. 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.

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

Conditions
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Gestational Diabetes Mellitus

Intervention / Treatment
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* Other: Standard Nutrition Therapy
* Other: Low Glycemic Index


Participation Criteria
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Eligibility Criteria
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Study I Inclusion Criteria: Pregnant women, aged 18-45 years Women diagnosed with Gestational Diabetes Mellitus (GDM) as early as 13 up to 28 weeks of gestation Pre-pregnancy BMI >23kg/m2 (using BMI cut-off point) for underweight and overweight of Asian as defined by World Health Organization (WHO, 2000) Treated with diet controlled or on insulin therapy Willing and able to comply with the study protocol Exclusion Criteria: Any gastrointestinal disease that interferes with bowel function and nutritional intake (i.e., diabetes-related constipation or diarrhea secondary to neuropathy, diarrhea due to chronic inflammatory bowel disease, gastroparesis, gastrectomy, galactosemia, hyperemesis Any medical problem that requires steroid (i.e., arthritis, asthma, autoimmune diseases and skin conditions such as eczema Incapability to comply with study protocol or investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements Study II Inclusion Criteria: Pregnant women, aged 18-45 years Only women diagnosed with Gestational Diabetes Mellitus (GDM) between 16 and 28 weeks of gestation Pre-pregnancy BMI >23kg/m2 (using BMI cut-off point) for underweight and overweight of Asian as defined by WHO (2000) Treated with diet-controlled alone Hemoglobin ≥10mmol/l (WHO, 2011) Willing and able to comply with the protocol Exclusion Criteria: Any gastrointestinal disease that interferes with bowel function and nutritional intake (i.e., diabetes-related constipation or diarrhea secondary to neuropathy, diarrhea due to chronic inflammatory bowel disease, gastroparesis, gastrectomy, galactosemia, hyperemesis) Currently on insulin therapy With known food allergy/ on a particular dietary requirement Incapability to comply with study protocol or investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Nutrition Therapy<br>Subjects in this group receive a standard nutrition therapy based on local guidelines that is usually high in fibre with moderate to high glycemic index food | Other: Standard Nutrition Therapy<br>* 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<br>|
| Experimental: Low Glycemic Index<br>Subjects in this group receive intervention on low glycemic index foods | Other: Low Glycemic Index<br>* Subjects will be advised to eat low glycemic index foods<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post meal blood glucose level | Average blood glucose profiles after breakfast, lunch and dinner measured using capillary blood glucose at home | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of Triglycerides | Changes in Fasting Triglycerides | 12 weeks | 
| Level of glycemic control | Changes in Fructosamine | 4 weeks | 
| Maternal weight gain | Changes in total weight gain based on Institute of Medicine (IOM) recommendations | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gestational Diabetes Mellitus, Glycemic index, Metabolic Response, Pregnancy Outcomes, Glycemic control