NCT03287297

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2017

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 16, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 19, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

September 20, 2017

Status Verified

September 1, 2017

Enrollment Period

6 months

First QC Date

September 16, 2017

Last Update Submit

September 18, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Blood Glucose Level

    Mean difference In Blood Glucose Level Among Cases

    Baseline

Interventions

OGTT & HBA1cDIAGNOSTIC_TEST

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

Eligibility Criteria

Age21 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThe study will include all pregnant women at 24th to 28th gestational age
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

The study will include all pregnant women at 24th to 28th gestational age, who attending to GDM Outpatient Clinic.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (10)

  • Alfadhli EM. Gestational diabetes mellitus. Saudi Med J. 2015 Apr;36(4):399-406. doi: 10.15537/smj.2015.4.10307.

    PMID: 25828275BACKGROUND
  • 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.

    PMID: 26180767BACKGROUND
  • 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.

    PMID: 26240703BACKGROUND
  • 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.

    PMID: 23815193BACKGROUND
  • 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.

    PMID: 26131321BACKGROUND
  • 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.

    PMID: 25228278BACKGROUND
  • 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.

    PMID: 21117358BACKGROUND
  • 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.

    PMID: 21613563BACKGROUND
  • 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.

    PMID: 16957814BACKGROUND
  • 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.

    PMID: 21709295BACKGROUND

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Glucose Tolerance Test

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, EndocrineInvestigative Techniques

Central Study Contacts

Nabila Fayek, Professor

CONTACT

Naglaa Mohamed, Lecturer

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

September 16, 2017

First Posted

September 19, 2017

Study Start

December 1, 2017

Primary Completion

June 1, 2018

Study Completion

December 1, 2019

Last Updated

September 20, 2017

Record last verified: 2017-09