<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/NCT03790579</url>
  </required_header>
  <id_info>
    <org_study_id>Hacettepe Nutrition</org_study_id>
    <nct_id>NCT03790579</nct_id>
  </id_info>
  <brief_title>Dietary Acid Load During Pregnancy and Gestational Diabetes Mellitus</brief_title>
  <official_title>Is There Any Effect of Maternal Dietary Acid Load During Pregnancy on Arising Gestational Diabetes Mellitus?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hacettepe University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hacettepe 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>
      Dietary habits resembling Western style, rich in animal protein and poor in fruit and&#xD;
      vegetables, increase the body acid load, a predictor of type 2 diabetes risk. Recently, the&#xD;
      studies related to relationships between dietary acid load and insulin resistance has become&#xD;
      a growing interest but there are only a few study conducted with gestational diabetes&#xD;
      mellitus (GDM). Therefore, the aim of this study was to evaluate the potential relationship&#xD;
      between dietary acid load in second trimester, blood lipid profiles and GDM.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This cross-sectional study conducted with 40 women with GDM diagnosed with two-step 100g oral&#xD;
      glucose tolerance test and 40 healthy women, aged 21-41 years, between weeks of 14-28 of&#xD;
      pregnancy, who attended the Department of Obstetrics and Gynecology of Gulhane Training and&#xD;
      Research Hospital. Participants with polycystic ovary syndrome, chronic diseases, pre-GDM, or&#xD;
      multiple pregnancies were excluded. Sociodemographic information was recorded via&#xD;
      questionnaire and anthropometrics of women were measured.&#xD;
&#xD;
      Blood samples were taken after an overnight fasting. Dietary information was obtained by mean&#xD;
      intakes of a 3-day food records (2 weekdays and 1 weekend day) and analyzed via nutrition&#xD;
      analysis software. According to the data obtained from software analysis, animal protein&#xD;
      (g/day) to potassium (g/day) ratio (AP/K), potential renal acid load (PRAL; mEq/day) score&#xD;
      and net endogenous acid production (NEAP; mEq/day) were calculated from established&#xD;
      algorithms to estimate dietary acid load. All nutrients were age and energy- adjusted before&#xD;
      being introduced into the equation and tertiles of the scores were used for statistical&#xD;
      analysis. ANOVA, ANCOVA and Logistic regression test were used. The study plan was approved&#xD;
      by the Hospital&amp;#39;s Ethics Committee.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 5, 2014</start_date>
  <completion_date type="Actual">October 5, 2014</completion_date>
  <primary_completion_date type="Actual">September 5, 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Dietary acid load</measure>
    <time_frame>24-28. weeks of pregnancy</time_frame>
    <description>According to the data obtained from software analysis, animal protein (g/day) to potassium (g/day) ratio (AP/K), potential renal acid load (PRAL; mEq/day) score and net endogenous acid production (NEAP; mEq/day) were calculated from established algorithms to estimate dietary acid load.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">80</enrollment>
  <condition>Diabetes, Gestational</condition>
  <condition>Dietary Habits</condition>
  <arm_group>
    <arm_group_label>Women with gestational diabetes</arm_group_label>
    <description>We randomly selected the 40 pregnant women diagnosed GDM by two-step procedure based on Carpenter-Coustan criteria at this hospital. The diagnosis of GDM was confirmed if at least 2 of 4 glucose levels exceed based on Carpenter-Coustan criteria: fasting ≥ 95 mg/dL (5.3 mmol/L), 1 hour ≥ 180 mg/dL ( 10.0 mmol/L), 2 hour ≥ 155 mg/dL (8.6 mmol/L), and 3 hour ≥ 140 mg/dL (7.8 mmol/L).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy women</arm_group_label>
    <description>We also randomly selected 40 healthy pregnant with normal serum glucose levels ≤129 mg/dL (7.2 mmol/L) after GCT.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        In this observational cross-sectional study, 40 women with GDM and 40 healthy pregnant&#xD;
        between 21-41 years in age, in their 24-28th gestational week applied to Gulhane Education&#xD;
        and Research Hospital were recruited. This study must recruit 40 women for each group to&#xD;
        have 80% study power with 5% type I error level to detect a clinically significant&#xD;
        difference.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Singleton pregnancy,&#xD;
&#xD;
          -  Aged in 20-40 years,&#xD;
&#xD;
          -  Gestational age 24-28 weeks,&#xD;
&#xD;
          -  Non-history of acute or chronic diseases.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of GDM,&#xD;
&#xD;
          -  Type 1 and 2 diabetes mellitus,&#xD;
&#xD;
          -  Preeclampsia,&#xD;
&#xD;
          -  Polycystic ovary syndrome,&#xD;
&#xD;
          -  Thyroid disease&#xD;
&#xD;
          -  Parathyroid disease,&#xD;
&#xD;
          -  Metabolic bone disease,&#xD;
&#xD;
          -  Kidney disease,&#xD;
&#xD;
          -  Abnormal liver function,&#xD;
&#xD;
          -  Multiple pregnancy&#xD;
&#xD;
          -  Extreme values of energy intake in their dietary records (&lt;1500 and &gt;4000 kkal).&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>41 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gülhan SAMUR, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hacettepe University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Gözde EDE, MSci</last_name>
    <role>Study Chair</role>
    <affiliation>Mehmet Akif Ersoy University</affiliation>
  </overall_official>
  <reference>
    <citation>Della Guardia L, Thomas MA, Cena H. Insulin Sensitivity and Glucose Homeostasis Can Be Influenced by Metabolic Acid Load. Nutrients. 2018 May 15;10(5):618. doi: 10.3390/nu10050618.</citation>
    <PMID>29762478</PMID>
  </reference>
  <reference>
    <citation>Jayedi A, Shab-Bidar S. Dietary acid load and risk of type 2 diabetes: A systematic review and dose-response meta-analysis of prospective observational studies. Clin Nutr ESPEN. 2018 Feb;23:10-18. doi: 10.1016/j.clnesp.2017.12.005. Epub 2017 Dec 23.</citation>
    <PMID>29460782</PMID>
  </reference>
  <reference>
    <citation>Williams RS, Kozan P, Samocha-Bonet D. The role of dietary acid load and mild metabolic acidosis in insulin resistance in humans. Biochimie. 2016 May;124:171-177. doi: 10.1016/j.biochi.2015.09.012. Epub 2015 Sep 10.</citation>
    <PMID>26363101</PMID>
  </reference>
  <results_reference>
    <citation>Gaede J, Nielsen T, Madsen ML, Toft U, Jorgensen T, Overvad K, Tjonneland A, Hansen T, Allin KH, Pedersen O. Population-based studies of relationships between dietary acidity load, insulin resistance and incident diabetes in Danes. Nutr J. 2018 Oct 6;17(1):91. doi: 10.1186/s12937-018-0395-1.</citation>
    <PMID>30292239</PMID>
  </results_reference>
  <results_reference>
    <citation>Saraf-Bank S, Tehrani H, Haghighatdoost F, Moosavian SP, Azadbakht L. The acidity of early pregnancy diet and risk of gestational diabetes mellitus. Clin Nutr. 2018 Dec;37(6 Pt A):2054-2059. doi: 10.1016/j.clnu.2017.09.020. Epub 2017 Oct 3.</citation>
    <PMID>29054469</PMID>
  </results_reference>
  <results_reference>
    <citation>Miki A, Hashimoto Y, Tanaka M, Kobayashi Y, Wada S, Kuwahata M, Kido Y, Yamazaki M, Fukui M. Urinary pH reflects dietary acid load in patients with type 2 diabetes. J Clin Biochem Nutr. 2017 Jul;61(1):74-77. doi: 10.3164/jcbn.16-118. Epub 2017 Jul 1.</citation>
    <PMID>28751813</PMID>
  </results_reference>
  <results_reference>
    <citation>Kiefte-de Jong JC, Li Y, Chen M, Curhan GC, Mattei J, Malik VS, Forman JP, Franco OH, Hu FB. Diet-dependent acid load and type 2 diabetes: pooled results from three prospective cohort studies. Diabetologia. 2017 Feb;60(2):270-279. doi: 10.1007/s00125-016-4153-7. Epub 2016 Nov 17.</citation>
    <PMID>27858141</PMID>
  </results_reference>
  <results_reference>
    <citation>Williams RS, Heilbronn LK, Chen DL, Coster AC, Greenfield JR, Samocha-Bonet D. Dietary acid load, metabolic acidosis and insulin resistance - Lessons from cross-sectional and overfeeding studies in humans. Clin Nutr. 2016 Oct;35(5):1084-90. doi: 10.1016/j.clnu.2015.08.002. Epub 2015 Aug 12.</citation>
    <PMID>26299332</PMID>
  </results_reference>
  <results_reference>
    <citation>Akter S, Eguchi M, Kuwahara K, Kochi T, Ito R, Kurotani K, Tsuruoka H, Nanri A, Kabe I, Mizoue T. High dietary acid load is associated with insulin resistance: The Furukawa Nutrition and Health Study. Clin Nutr. 2016 Apr;35(2):453-459. doi: 10.1016/j.clnu.2015.03.008. Epub 2015 Mar 27.</citation>
    <PMID>25863769</PMID>
  </results_reference>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 28, 2018</study_first_submitted>
  <study_first_submitted_qc>December 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 31, 2018</study_first_posted>
  <last_update_submitted>December 29, 2018</last_update_submitted>
  <last_update_submitted_qc>December 29, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 2, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hacettepe University</investigator_affiliation>
    <investigator_full_name>F. Gülhan Samur</investigator_full_name>
    <investigator_title>Professor doctor</investigator_title>
  </responsible_party>
  <keyword>Gestational diabetes mellitus</keyword>
  <keyword>Dietary acid load</keyword>
  <keyword>Pregnancy</keyword>
  <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>No</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/NCT03790579
org study id: Hacettepe Nutrition
nct id: NCT03790579
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Dietary habits resembling Western style, rich in animal protein and poor in fruit and
      vegetables, increase the body acid load, a predictor of type 2 diabetes risk. Recently, the
      studies related to relationships between dietary acid load and insulin resistance has become
      a growing interest but there are only a few study conducted with gestational diabetes
      mellitus (GDM). Therefore, the aim of this study was to evaluate the potential relationship
      between dietary acid load in second trimester, blood lipid profiles and GDM.
This cross-sectional study conducted with 40 women with GDM diagnosed with two-step 100g oral
      glucose tolerance test and 40 healthy women, aged 21-41 years, between weeks of 14-28 of
      pregnancy, who attended the Department of Obstetrics and Gynecology of Gulhane Training and
      Research Hospital. Participants with polycystic ovary syndrome, chronic diseases, pre-GDM, or
      multiple pregnancies were excluded. Sociodemographic information was recorded via
      questionnaire and anthropometrics of women were measured.

      Blood samples were taken after an overnight fasting. Dietary information was obtained by mean
      intakes of a 3-day food records (2 weekdays and 1 weekend day) and analyzed via nutrition
      analysis software. According to the data obtained from software analysis, animal protein
      (g/day) to potassium (g/day) ratio (AP/K), potential renal acid load (PRAL; mEq/day) score
      and net endogenous acid production (NEAP; mEq/day) were calculated from established
      algorithms to estimate dietary acid load. All nutrients were age and energy- adjusted before
      being introduced into the equation and tertiles of the scores were used for statistical
      analysis. ANOVA, ANCOVA and Logistic regression test were used. The study plan was approved
      by the Hospital&#39;s Ethics Committee.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Dietary acid load
time frame: 24-28. weeks of pregnancy
description: According to the data obtained from software analysis, animal protein (g/day) to potassium (g/day) ratio (AP/K), potential renal acid load (PRAL; mEq/day) score and net endogenous acid production (NEAP; mEq/day) were calculated from established algorithms to estimate dietary acid load.
arm group label: Women with gestational diabetes
description: We randomly selected the 40 pregnant women diagnosed GDM by two-step procedure based on Carpenter-Coustan criteria at this hospital. The diagnosis of GDM was confirmed if at least 2 of 4 glucose levels exceed based on Carpenter-Coustan criteria: fasting ≥ 95 mg/dL (5.3 mmol/L), 1 hour ≥ 180 mg/dL ( 10.0 mmol/L), 2 hour ≥ 155 mg/dL (8.6 mmol/L), and 3 hour ≥ 140 mg/dL (7.8 mmol/L).
arm group label: Healthy women
description: We also randomly selected 40 healthy pregnant with normal serum glucose levels ≤129 mg/dL (7.2 mmol/L) after GCT.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
minimum age: 21 Years
maximum age: 41 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Gülhan SAMUR, Professor
role: Principal Investigator
affiliation: Hacettepe University
last name: Gözde EDE, MSci
role: Study Chair
affiliation: Mehmet Akif Ersoy University
citation: Della Guardia L, Thomas MA, Cena H. Insulin Sensitivity and Glucose Homeostasis Can Be Influenced by Metabolic Acid Load. Nutrients. 2018 May 15;10(5):618. doi: 10.3390/nu10050618.
PMID: 29762478
citation: Jayedi A, Shab-Bidar S. Dietary acid load and risk of type 2 diabetes: A systematic review and dose-response meta-analysis of prospective observational studies. Clin Nutr ESPEN. 2018 Feb;23:10-18. doi: 10.1016/j.clnesp.2017.12.005. Epub 2017 Dec 23.
PMID: 29460782
citation: Williams RS, Kozan P, Samocha-Bonet D. The role of dietary acid load and mild metabolic acidosis in insulin resistance in humans. Biochimie. 2016 May;124:171-177. doi: 10.1016/j.biochi.2015.09.012. Epub 2015 Sep 10.
PMID: 26363101
citation: Gaede J, Nielsen T, Madsen ML, Toft U, Jorgensen T, Overvad K, Tjonneland A, Hansen T, Allin KH, Pedersen O. Population-based studies of relationships between dietary acidity load, insulin resistance and incident diabetes in Danes. Nutr J. 2018 Oct 6;17(1):91. doi: 10.1186/s12937-018-0395-1.
PMID: 30292239
citation: Saraf-Bank S, Tehrani H, Haghighatdoost F, Moosavian SP, Azadbakht L. The acidity of early pregnancy diet and risk of gestational diabetes mellitus. Clin Nutr. 2018 Dec;37(6 Pt A):2054-2059. doi: 10.1016/j.clnu.2017.09.020. Epub 2017 Oct 3.
PMID: 29054469
citation: Miki A, Hashimoto Y, Tanaka M, Kobayashi Y, Wada S, Kuwahata M, Kido Y, Yamazaki M, Fukui M. Urinary pH reflects dietary acid load in patients with type 2 diabetes. J Clin Biochem Nutr. 2017 Jul;61(1):74-77. doi: 10.3164/jcbn.16-118. Epub 2017 Jul 1.
PMID: 28751813
citation: Kiefte-de Jong JC, Li Y, Chen M, Curhan GC, Mattei J, Malik VS, Forman JP, Franco OH, Hu FB. Diet-dependent acid load and type 2 diabetes: pooled results from three prospective cohort studies. Diabetologia. 2017 Feb;60(2):270-279. doi: 10.1007/s00125-016-4153-7. Epub 2016 Nov 17.
PMID: 27858141
citation: Williams RS, Heilbronn LK, Chen DL, Coster AC, Greenfield JR, Samocha-Bonet D. Dietary acid load, metabolic acidosis and insulin resistance - Lessons from cross-sectional and overfeeding studies in humans. Clin Nutr. 2016 Oct;35(5):1084-90. doi: 10.1016/j.clnu.2015.08.002. Epub 2015 Aug 12.
PMID: 26299332
citation: Akter S, Eguchi M, Kuwahara K, Kochi T, Ito R, Kurotani K, Tsuruoka H, Nanri A, Kabe I, Mizoue T. High dietary acid load is associated with insulin resistance: The Furukawa Nutrition and Health Study. Clin Nutr. 2016 Apr;35(2):453-459. doi: 10.1016/j.clnu.2015.03.008. Epub 2015 Mar 27.
PMID: 25863769
responsible party type: Principal Investigator
investigator affiliation: Hacettepe University
investigator full name: F. Gülhan Samur
investigator title: Professor doctor
mesh term: Diabetes, Gestational
mesh term: Diabetes Mellitus
sharing ipd: No