Status:
COMPLETED
Effect of Low Glycemic Index on Gestational Diabetes Mellitus
Lead Sponsor:
Universiti Putra Malaysia
Collaborating Sponsors:
National University of Malaysia
Conditions:
Gestational Diabetes Mellitus
Eligibility:
FEMALE
18-45 years
Phase:
NA
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 post...
Eligibility Criteria
Inclusion
- Study I
- 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
- 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
Key Trial Info
Start Date :
April 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03801824
Start Date
April 1 2014
End Date
September 1 2016
Last Update
January 25 2019
Active Locations (1)
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1
Universiti Kebangsaan Malaysia Medical Centre
Cheras, Kuala Lumpur, Malaysia, 56000