Status:
COMPLETED
Effects of Probiotics on Gut Microbiota Composition and Metabolic Outcomes in Post- Gestational Diabetes Women
Lead Sponsor:
National University of Malaysia
Collaborating Sponsors:
B-Crobes Laboratory (M) Sdn Bhd
Ministry of Higher Education, Malaysia
Conditions:
Gestational Diabetes
Eligibility:
FEMALE
18-45 years
Phase:
NA
Brief Summary
Risk of developing diabetes at a younger age among women with a previous history of gestational diabetes mellitus (post-GDM) has increased by 10-fold compared to the healthy women. However, consistent...
Detailed Description
Recent evidence highlighted disturbances in gut microbial compositions were associated with impairment of glucose and inflammation metabolism in women with GDM. Probiotics were hypothesized will modul...
Eligibility Criteria
Inclusion
- Women aged 18-45 years.
- Attended postnatal follow-up at Universiti Kebangsaan Medical Center (four to eight weeks postpartum).
- Have a recent history of gestational diabetes mellitus.
- Willing to participate in the study.
- Had either postpartum glucose intolerance, overweight (BMI ≥23 kg/m2), or obese (BMI ≥27.5 kg/m2) during eligibility assessment.
Exclusion
- Postpartum fasting blood glucose (FBG) level \>8.0 mmol/L, two-hour postprandial (2HPP) glucose level \>12 mmol/L.
- Symptomatic of hyperglycemia and started on hypoglycemic agent.
- Have underlying medical illnesses and required regular medications (i.e., pre- pregnancy diabetes, hypertension, congestive heart failure, renal failure, liver cirrhosis, gastrointestinal diseases, autoimmune diseases, and cancer) before and during intervention.
- Had taken antibiotics / regularly consumed food or supplements rich in prebiotics/probiotics/symbiotics less than 12-week before recruitment or during intervention.
Key Trial Info
Start Date :
March 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 26 2021
Estimated Enrollment :
166 Patients enrolled
Trial Details
Trial ID
NCT05273073
Start Date
March 1 2018
End Date
April 26 2021
Last Update
March 10 2022
Active Locations (1)
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1
Universiti Kebangsaan Malaysia
Cheras, Kuala Lumpur, Malaysia, 56000