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Status unknownNCT03287297Updated Sep 20, 2017

Association Between Dietary Habits and Gestational Diabetes

An observational study in Gestational Diabetes Mellitus, sponsored by Assiut University. Status unknown. Open to female participants aged 21 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-20.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Sep 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
150
Ages
21 Years to 45 Years
Sex
Female
01

Study 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.

Read the 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).
02

Conditions studied

  • Gestational Diabetes Mellitus
03

Who can participate

Ages eligible
21 Years to 45 Years
Sexes eligible
Female
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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • include pre-gestational diabetic women and pregnant women before and after 24th -28th week of gestation.
04

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
150 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testOGTT & HBA1c

    oral glucose tolerance test \& HBA1c: by measuring glycated hemoglobin

05

What researchers measure

Primary outcomes

  1. Blood Glucose Level

    Mean difference In Blood Glucose Level Among Cases

    Time frame: Baseline

06

Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • Alfadhli EM. Gestational diabetes mellitus. Saudi Med J. 2015 Apr;36(4):399-406. doi: 10.15537/smj.2015.4.10307. PubMed 25828275 ↗
  • Bhatt AA, Dhore PB, Purandare VB, Sayyad MG, Mandal MK, Unnikrishnan AG. Gestational diabetes mellitus in rural population of Western India - Results of a community survey. Indian J Endocrinol Metab. 2015 Jul-Aug;19(4):507-10. doi: 10.4103/2230-8210.159061. PubMed 26180767 ↗
  • Kampmann U, Madsen LR, Skajaa GO, Iversen DS, Moeller N, Ovesen P. Gestational diabetes: A clinical update. World J Diabetes. 2015 Jul 25;6(8):1065-72. doi: 10.4239/wjd.v6.i8.1065. PubMed 26240703 ↗
  • Poomalar GK, Rangaswamy V. A comparison of fasting plasma glucose and glucose challenge test for screening of gestational diabetes mellitus. J Obstet Gynaecol. 2013 Jul;33(5):447-50. doi: 10.3109/01443615.2013.771156. PubMed 23815193 ↗
  • Agarwal MM. Gestational diabetes mellitus: An update on the current international diagnostic criteria. World J Diabetes. 2015 Jun 25;6(6):782-91. doi: 10.4239/wjd.v6.i6.782. PubMed 26131321 ↗
  • Ovesen PG, Jensen DM, Damm P, Rasmussen S, Kesmodel US. Maternal and neonatal outcomes in pregnancies complicated by gestational diabetes. a nation-wide study. J Matern Fetal Neonatal Med. 2015;28(14):1720-4. doi: 10.3109/14767058.2014.966677. Epub 2015 Jan 8. PubMed 25228278 ↗
  • Seshiah V; Diabetes in Pregnancy Study Group. Fifth National Conference of Diabetes in Pregnancy Study Group, India. J Assoc Physicians India. 2010 May;58:329-30. No abstract available. PubMed 21117358 ↗
  • Zhang C, Ning Y. Effect of dietary and lifestyle factors on the risk of gestational diabetes: review of epidemiologic evidence. Am J Clin Nutr. 2011 Dec;94(6 Suppl):1975S-1979S. doi: 10.3945/ajcn.110.001032. Epub 2011 May 25. PubMed 21613563 ↗
  • Zhang C, Schulze MB, Solomon CG, Hu FB. A prospective study of dietary patterns, meat intake and the risk of gestational diabetes mellitus. Diabetologia. 2006 Nov;49(11):2604-13. doi: 10.1007/s00125-006-0422-1. Epub 2006 Sep 7. PubMed 16957814 ↗
  • Qiu C, Zhang C, Gelaye B, Enquobahrie DA, Frederick IO, Williams MA. Gestational diabetes mellitus in relation to maternal dietary heme iron and nonheme iron intake. Diabetes Care. 2011 Jul;34(7):1564-9. doi: 10.2337/dc11-0135. PubMed 21709295 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT03287297
Lead sponsor
Assiut University
Responsible party
Mahmoud Mokhtar Abdel-Hameed (Principal investigator, Assiut University) — Principal investigator
First posted
Sep 19, 2017
Start date
Dec 1, 2017 (estimated)
Primary completion
Jun 1, 2018 (estimated)
Completion
Dec 1, 2019 (estimated)
Last update
Sep 20, 2017

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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