Gestational Diabetes Mellitus
Conditions
Keywords
Gestational Diabetes Mellitus, Glycemic index, Metabolic Response, Pregnancy Outcomes, Glycemic control
Brief 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.
Interventions
OTHERStandard Nutrition Therapy
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
OTHERLow Glycemic Index
Subjects will be advised to eat low glycemic index foods
Sponsors
National University of Malaysia
Universiti Putra Malaysia
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post meal blood glucose level | 12 weeks | Average blood glucose profiles after breakfast, lunch and dinner measured using capillary blood glucose at home |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Level of Triglycerides | 12 weeks | Changes in Fasting Triglycerides |
| Level of glycemic control | 4 weeks | Changes in Fructosamine |
| Maternal weight gain | 12 weeks | Changes in total weight gain based on Institute of Medicine (IOM) recommendations |
Other
| Measure | Time frame | Description |
|---|---|---|
| Level of post-meal blood glucose | 3 hour post-prandial | Changes in post-meal blood glucose level |
Countries
Malaysia
Outcome results
None listed