Association Between Dietary Habits and Gestational Diabetes

September 18, 2017 updated by: Mahmoud Mokhtar Abdel-Hameed, Assiut University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood Glucose Level
Time Frame: Baseline
Mean difference In Blood Glucose Level Among Cases
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2017

Primary Completion (Anticipated)

June 1, 2018

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

September 16, 2017

First Submitted That Met QC Criteria

September 16, 2017

First Posted (Actual)

September 19, 2017

Study Record Updates

Last Update Posted (Actual)

September 20, 2017

Last Update Submitted That Met QC Criteria

September 18, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17100275

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Gestational Diabetes Mellitus

Clinical Trials on OGTT & HBA1c

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Macedonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe