<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03287297</url>
  </required_header>
  <id_info>
    <org_study_id>17100275</org_study_id>
    <nct_id>NCT03287297</nct_id>
  </id_info>
  <brief_title>Association Between Dietary Habits and Gestational Diabetes</brief_title>
  <official_title>Association Between Dietary Habits and Gestational Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Gestational diabetes mellitus (GDM) is defined as carbohydrate intolerance of varying&#xD;
      severity with onset or first recognition during pregnancy. The diagnosis of gestational&#xD;
      diabetes is important, because of the increased risk of adverse maternal and feto-neonatal&#xD;
      outcomes. In addition, GDM also confers a future risk of type 2 diabetes to mothers and their&#xD;
      fetus. Dietary components associated with GDM risk include macronutrients, micronutrients,&#xD;
      and individual foods, such as refined carbohydrates, saturated fats, soft drinks and&#xD;
      processed meats. The Pre-pregnancy dietary patterns may affect women risk of developing GDM.&#xD;
      A diet high in red and processed meat was associated with a significantly elevated risk.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      *Aim of the work: To investigate associations between maternal dietary patterns and GDM.&#xD;
&#xD;
        -  Patients and Methods:&#xD;
&#xD;
             -  Study design: A cross sectional study was conducted.&#xD;
&#xD;
             -  Study site: GDM Outpatient Clinic of Assiut University Hospital.&#xD;
&#xD;
             -  Study population: The study will include all pregnant women at 24th to 28th&#xD;
                gestational age, who attending to GDM Outpatient Clinic during the period of The&#xD;
                Study.&#xD;
&#xD;
             -  Inclusion criteria include pregnant women at 24th to 28th age of gestation.&#xD;
&#xD;
             -  Exclusion criteria include pre-gestational diabetic women and pregnant women before&#xD;
                and after 24th -28th week of gestation.&#xD;
&#xD;
             -  Instrument: Structured designed questionnaire: Which consists of socio-demographic&#xD;
                characteristics, Medical and obstetric history and other risk factors for GDM&#xD;
                including previous GDM, family history of diabetes, twins in current pregnancy,&#xD;
                history of PCO and macrosomic baby in current or previous pregnancy, also contains&#xD;
                information about regularity and frequencies of daily meals taken by the women, and&#xD;
                information about food group frequencies per week, food groups like vegetables,&#xD;
                fruits, fast food , red and processed meat, fish and seafood, whole grains, cereal&#xD;
                fiber, sweetened beverage, dessert food and use of multivitamins.&#xD;
&#xD;
             -  Data collection: Direct interview will be done with each participant separately for&#xD;
                filling the food frequency questionnaire by the researcher himself during the&#xD;
                period from January 2017 to June 2017&#xD;
&#xD;
        -  Clinical examination:&#xD;
&#xD;
             -  BP (mmHg)&#xD;
&#xD;
             -  Pulse&#xD;
&#xD;
             -  Body Weight (kg)&#xD;
&#xD;
             -  Height (cm)&#xD;
&#xD;
             -  BMI&#xD;
&#xD;
      Laboratory Examination&#xD;
&#xD;
        -  OGTT (75gm) 2hr&#xD;
&#xD;
        -  HBA1c (if Bl. Glucose ≥ 200mg/dl).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">December 1, 2017</start_date>
  <completion_date type="Anticipated">December 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Blood Glucose Level</measure>
    <time_frame>Baseline</time_frame>
    <description>Mean difference In Blood Glucose Level Among Cases</description>
  </primary_outcome>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Gestational Diabetes Mellitus</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>OGTT &amp; HBA1c</intervention_name>
    <description>oral glucose tolerance test &amp; HBA1c: by measuring glycated hemoglobin</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study will include all pregnant women at 24th to 28th gestational age, who attending to&#xD;
        GDM Outpatient Clinic.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  include pregnant women at 24th to 28th age of gestation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  include pre-gestational diabetic women and pregnant women before and after 24th -28th&#xD;
             week of gestation.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>The study will include all pregnant women at 24th to 28th gestational age</gender_description>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Nabila Fayek, Professor</last_name>
    <phone>0201226341736</phone>
    <email>nabilaameen13@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Naglaa Mohamed, Lecturer</last_name>
    <phone>0201004069708</phone>
    <email>dr_naglaamousa@yahoo.com</email>
  </overall_contact_backup>
  <reference>
    <citation>Alfadhli EM. Gestational diabetes mellitus. Saudi Med J. 2015 Apr;36(4):399-406. doi: 10.15537/smj.2015.4.10307.</citation>
    <PMID>25828275</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>26180767</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>26240703</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>23815193</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>26131321</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>25228278</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>21117358</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>21613563</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>16957814</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>21709295</PMID>
  </reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 16, 2017</study_first_submitted>
  <study_first_submitted_qc>September 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 19, 2017</study_first_posted>
  <last_update_submitted>September 18, 2017</last_update_submitted>
  <last_update_submitted_qc>September 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 20, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Mahmoud Mokhtar Abdel-Hameed</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes, Gestational</mesh_term>
    <mesh_term>Diabetes Mellitus</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03287297
org study id: 17100275
nct id: NCT03287297
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
*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).
observational model: Cohort
time perspective: Cross-Sectional
measure: Blood Glucose Level
time frame: Baseline
description: Mean difference In Blood Glucose Level Among Cases
intervention type: Diagnostic Test
intervention name: OGTT & HBA1c
description: oral glucose tolerance test & HBA1c: by measuring glycated hemoglobin
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: The study will include all pregnant women at 24th to 28th gestational age
minimum age: 21 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Nabila Fayek, Professor
phone: 0201226341736
email: nabilaameen13@yahoo.com
last name: Naglaa Mohamed, Lecturer
phone: 0201004069708
email: dr_naglaamousa@yahoo.com
citation: Alfadhli EM. Gestational diabetes mellitus. Saudi Med J. 2015 Apr;36(4):399-406. doi: 10.15537/smj.2015.4.10307.
PMID: 25828275
citation: 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: 26180767
citation: 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: 26240703
citation: 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: 23815193
citation: 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: 26131321
citation: 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: 25228278
citation: 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: 21117358
citation: 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: 21613563
citation: 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: 16957814
citation: 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: 21709295
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Mahmoud Mokhtar Abdel-Hameed
investigator title: Principal investigator
mesh term: Diabetes, Gestational
mesh term: Diabetes Mellitus
sharing ipd: Undecided