Association Between Dietary Habits and Gestational Diabetes
NCT ID: NCT03287297
Last Updated: 2017-09-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
150 participants
OBSERVATIONAL
2017-12-01
2019-12-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* 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).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
CROSS_SECTIONAL
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
OGTT & HBA1c
oral glucose tolerance test \& HBA1c: by measuring glycated hemoglobin
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
21 Years
45 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Assiut University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Mahmoud Mokhtar Abdel-Hameed
Principal investigator
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
References
Explore related publications, articles, or registry entries linked to this study.
Alfadhli EM. Gestational diabetes mellitus. Saudi Med J. 2015 Apr;36(4):399-406. doi: 10.15537/smj.2015.4.10307.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
17100275
Identifier Type: -
Identifier Source: org_study_id