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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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7 November 2022 |
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Main ID: |
NCT04273412 |
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Date of registration:
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09/02/2020 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Lifestyle Intervention for Prevention of Gestational Diabetes Mellitus in the UAE Population
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Scientific title:
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Lifestyle Intervention for the Prevention of Gestational Diabetes Mellitus Among High-risk UAE Population |
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Date of first enrolment:
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October 13, 2018 |
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Target sample size:
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61 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT04273412 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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United Arab Emirates
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Contacts
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Name:
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Amena Sadiya, Ph.D |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sheikh Khalifa Medical City Ajman |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
The study will include pregnant females (= 12 weeks of gestation), singleton pregnancy who
meet = 2 risk factors for GDM stated below:
- High Risk ethnic group (South Asian, Middle Eastern, Black Carribean)
- Family history of type 2 diabetes, especially in first-degree relatives
- previous macrosomic baby weighing >4.5 kg
- Body mass index greater than 30 kg/m2
- Previous history of GDM or polycystic ovarian syndrome
Exclusion Criteria:
- Any form of pregestational diabetes
- Fasting glucose > 126 mg/dL at first prenatal visit.
- Currently using corticosteroids, metformin or other medications interfering with
glucose metabolism
- Psychiatric disorders
- Medical conditions preventing any physical exercise.
Age minimum:
18 Years
Age maximum:
45 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Gestational Diabetes Mellitus in Pregnancy
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Intervention(s)
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Behavioral: moderate-intensity lifestyle intervention
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Primary Outcome(s)
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incidence of gestational diabetes mellitus
[Time Frame: 24-28 weeks of gestation]
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Secondary Outcome(s)
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feto-maternal
[Time Frame: on delivery]
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feto-maternal outcomes
[Time Frame: on delivery]
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feto-maternall outcome
[Time Frame: on delivery]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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