Clinical trial NCT03287297: Association Between Dietary Habits and Gestational Diabetes
Official title: Association Between Dietary Habits and Gestational Diabetes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gestational Diabetes Mellitus
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-09-19
Enrollment: 150
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

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).

Eligibility 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.

Primary outcomes:
measure: Blood Glucose Level
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
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