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Association Between Dietary Habits and Gestational Diabetes

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ClinicalTrials.gov Identifier: NCT03287297
Recruitment Status : Not yet recruiting
First Posted : September 19, 2017
Last Update Posted : September 20, 2017
Sponsor:
Information provided by (Responsible Party):
Mahmoud Mokhtar Abdel-Hameed, Assiut University

Brief Summary:
Gestational diabetes mellitus (GDM) is defined as carbohydrate intolerance of varying severity with onset or first recognition during pregnancy. The diagnosis of gestational diabetes is important, because of the increased risk of adverse maternal and feto-neonatal outcomes. In addition, GDM also confers a future risk of type 2 diabetes to mothers and their fetus. Dietary components associated with GDM risk include macronutrients, micronutrients, and individual foods, such as refined carbohydrates, saturated fats, soft drinks and processed meats. The Pre-pregnancy dietary patterns may affect women risk of developing GDM. A diet high in red and processed meat was associated with a significantly elevated risk.

Condition or disease Intervention/treatment
Gestational Diabetes Mellitus Diagnostic Test: OGTT & HBA1c

Detailed Description:

*Aim of the work: To investigate associations between maternal dietary patterns and GDM.

  • Patients and Methods:

    • Study design: A cross sectional study was conducted.
    • Study site: GDM Outpatient Clinic of Assiut University Hospital.
    • Study population: The study will include all pregnant women at 24th to 28th gestational age, who attending to GDM Outpatient Clinic during the period of The Study.
    • Inclusion criteria include pregnant women at 24th to 28th age of gestation.
    • Exclusion criteria include pre-gestational diabetic women and pregnant women before and after 24th -28th week of gestation.
    • Instrument: Structured designed questionnaire: Which consists of socio-demographic characteristics, Medical and obstetric history and other risk factors for GDM including previous GDM, family history of diabetes, twins in current pregnancy, history of PCO and macrosomic baby in current or previous pregnancy, also contains information about regularity and frequencies of daily meals taken by the women, and information about food group frequencies per week, food groups like vegetables, fruits, fast food , red and processed meat, fish and seafood, whole grains, cereal fiber, sweetened beverage, dessert food and use of multivitamins.
    • Data collection: Direct interview will be done with each participant separately for filling the food frequency questionnaire by the researcher himself during the period from January 2017 to June 2017
  • Clinical examination:

    • BP (mmHg)
    • Pulse
    • Body Weight (kg)
    • Height (cm)
    • BMI

Laboratory Examination

  • OGTT (75gm) 2hr
  • HBA1c (if Bl. Glucose ≥ 200mg/dl).

Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Association Between Dietary Habits and Gestational Diabetes
Estimated Study Start Date : December 1, 2017
Estimated Primary Completion Date : June 1, 2018
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: OGTT & HBA1c
    oral glucose tolerance test & HBA1c: by measuring glycated hemoglobin


Primary Outcome Measures :
  1. Blood Glucose Level [ Time Frame: Baseline ]
    Mean difference In Blood Glucose Level Among Cases



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Ages Eligible for Study:   21 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   The study will include all pregnant women at 24th to 28th gestational age
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
The study will include all pregnant women at 24th to 28th gestational age, who attending to GDM Outpatient Clinic.
Criteria

Inclusion Criteria:

  • include pregnant women at 24th to 28th age of gestation.

Exclusion Criteria:

  • include pre-gestational diabetic women and pregnant women before and after 24th -28th week of gestation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03287297


Contacts
Contact: Nabila Fayek, Professor 0201226341736 nabilaameen13@yahoo.com
Contact: Naglaa Mohamed, Lecturer 0201004069708 dr_naglaamousa@yahoo.com

Sponsors and Collaborators
Assiut University

Publications:

Responsible Party: Mahmoud Mokhtar Abdel-Hameed, Principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03287297     History of Changes
Other Study ID Numbers: 17100275
First Posted: September 19, 2017    Key Record Dates
Last Update Posted: September 20, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications