<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/NCT03801824</url>
  </required_header>
  <id_info>
    <org_study_id>5450647</org_study_id>
    <nct_id>NCT03801824</nct_id>
  </id_info>
  <brief_title>Effect of Low Glycemic Index on Gestational Diabetes Mellitus</brief_title>
  <acronym>MyLGI</acronym>
  <official_title>Investigating the Effectiveness of a Low Glycemic Index on Glycemic Control and Pregnancy Outcomes in Women With Gestational Diabetes Mellitus: A Randomised Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universiti Putra Malaysia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National University of Malaysia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Universiti Putra Malaysia</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether glycemic index is effective in the&#xD;
      treatment of maternal glycemia and pregnancy outcomes in women with Gestational Diabetes&#xD;
      Mellitus.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. This research is divided into 2, that are study I and study II&#xD;
&#xD;
        1. Study I, is to determine the long-term effects of intervention (low GI and SNT) on&#xD;
           maternal glycemia, pregnancy outcomes and postprandial metabolic markers in women with&#xD;
           GDM&#xD;
&#xD;
             -  A total of 110 women with confirmed diagnosis of GDM will be recruited&#xD;
&#xD;
             -  They will be randomized either to receive low GI (n=55) or Standard Nutrition&#xD;
                Therapy (SNT; n=55)&#xD;
&#xD;
             -  The intervention will be started as soon as the women being diagnosed with GDM and&#xD;
                they will be followed-up every month until delivery and up to the 3-month&#xD;
                postpartum.&#xD;
&#xD;
             -  The primary outcome measures include glycemic control parameters as assessed by&#xD;
                fasting and postprandial glycemia, fructosamine, HbA1c, insulin level and&#xD;
                requirement for insulin treatment.&#xD;
&#xD;
             -  Secondary outcomes include lipid profile, weight gain, measures of postprandial&#xD;
                metabolic response (free fatty acid and triglyceride), pregnancy outcomes, and&#xD;
                overall improvement in postpartum metabolic parameters.&#xD;
&#xD;
        2. Study II, a sub-Mixed-meal Tolerant Test (MTT) study will be conducted to determine&#xD;
           postprandial glycemic and metabolic responses before and after 4-weeks of intensive&#xD;
           intervention&#xD;
&#xD;
             -  During the 4-weeks of intensive intervention, the subjects will receive&#xD;
                individualise counseling and daily food supply regarding the allocated study group.&#xD;
&#xD;
             -  A minimum of 19 subjects from a pool of 110 subjects who is participated in the&#xD;
                intervention study will be recruited.&#xD;
&#xD;
             -  The MTT procedure is similar to the oral glucose tolerant test (OGTT) but the&#xD;
                subject will be asked to consume the real mixed meals representing low and high GI&#xD;
                foods rather than oral glucose solution.&#xD;
&#xD;
             -  Subject will be asked to consume the test meal (either low or high GI foods) and&#xD;
                the blood will be sampled before and after consuming the test meal in two different&#xD;
                occasions with 1-week wash-out period.&#xD;
&#xD;
             -  After one month of intensive intervention, 19 subjects from each arm will undergo&#xD;
                the final HGI meal tolerant test (MTT3) and the same procedure of MTT 1 and 2&#xD;
&#xD;
             -  Approximately 32μl of capillary blood by finger-prick will be obtained 7 times per&#xD;
                MTT session, which is every 30 minutes thereafter to complete 3-h postprandial meal&#xD;
                for each set of meal tests.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 2014</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">June 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Post meal blood glucose level</measure>
    <time_frame>12 weeks</time_frame>
    <description>Average blood glucose profiles after breakfast, lunch and dinner measured using capillary blood glucose at home</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Level of Triglycerides</measure>
    <time_frame>12 weeks</time_frame>
    <description>Changes in Fasting Triglycerides</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Level of glycemic control</measure>
    <time_frame>4 weeks</time_frame>
    <description>Changes in Fructosamine</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal weight gain</measure>
    <time_frame>12 weeks</time_frame>
    <description>Changes in total weight gain based on Institute of Medicine (IOM) recommendations</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Level of post-meal blood glucose</measure>
    <time_frame>3 hour post-prandial</time_frame>
    <description>Changes in post-meal blood glucose level</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Gestational Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Standard Nutrition Therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects in this group receive a standard nutrition therapy based on local guidelines that is usually high in fibre with moderate to high glycemic index food</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low Glycemic Index</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects in this group receive intervention on low glycemic index foods</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard Nutrition Therapy</intervention_name>
    <description>Subjects will be advised on standard diet appropriate for the management of Gestational Diabetes Mellitus (GDM) designed to be high in fiber and have moderate to high dietary glycemic index</description>
    <arm_group_label>Standard Nutrition Therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Low Glycemic Index</intervention_name>
    <description>Subjects will be advised to eat low glycemic index foods</description>
    <arm_group_label>Low Glycemic Index</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Study I&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnant women, aged 18-45 years&#xD;
&#xD;
          -  Women diagnosed with Gestational Diabetes Mellitus (GDM) as early as 13 up to 28 weeks&#xD;
             of gestation&#xD;
&#xD;
          -  Pre-pregnancy BMI &gt;23kg/m2 (using BMI cut-off point) for underweight and overweight of&#xD;
             Asian as defined by World Health Organization (WHO, 2000)&#xD;
&#xD;
          -  Treated with diet controlled or on insulin therapy&#xD;
&#xD;
          -  Willing and able to comply with the study protocol&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any gastrointestinal disease that interferes with bowel function and nutritional&#xD;
             intake (i.e., diabetes-related constipation or diarrhea secondary to neuropathy,&#xD;
             diarrhea due to chronic inflammatory bowel disease, gastroparesis, gastrectomy,&#xD;
             galactosemia, hyperemesis&#xD;
&#xD;
          -  Any medical problem that requires steroid (i.e., arthritis, asthma, autoimmune&#xD;
             diseases and skin conditions such as eczema&#xD;
&#xD;
          -  Incapability to comply with study protocol or investigator's uncertainty about the&#xD;
             willingness or ability of the subject to comply with the protocol requirements&#xD;
&#xD;
        Study II&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnant women, aged 18-45 years&#xD;
&#xD;
          -  Only women diagnosed with Gestational Diabetes Mellitus (GDM) between 16 and 28 weeks&#xD;
             of gestation&#xD;
&#xD;
          -  Pre-pregnancy BMI &gt;23kg/m2 (using BMI cut-off point) for underweight and overweight of&#xD;
             Asian as defined by WHO (2000)&#xD;
&#xD;
          -  Treated with diet-controlled alone&#xD;
&#xD;
          -  Hemoglobin ≥10mmol/l (WHO, 2011)&#xD;
&#xD;
          -  Willing and able to comply with the protocol&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any gastrointestinal disease that interferes with bowel function and nutritional&#xD;
             intake (i.e., diabetes-related constipation or diarrhea secondary to neuropathy,&#xD;
             diarrhea due to chronic inflammatory bowel disease, gastroparesis, gastrectomy,&#xD;
             galactosemia, hyperemesis)&#xD;
&#xD;
          -  Currently on insulin therapy&#xD;
&#xD;
          -  With known food allergy/ on a particular dietary requirement&#xD;
&#xD;
          -  Incapability to comply with study protocol or investigator's uncertainty about the&#xD;
             willingness or ability of the subject to comply with the protocol requirements&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Barakatun-Nisak Mohd Yusof, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universiti Putra Malaysia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Universiti Kebangsaan Malaysia Medical Centre</name>
      <address>
        <city>Cheras</city>
        <state>Kuala Lumpur</state>
        <zip>56000</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Malaysia</country>
  </location_countries>
  <reference>
    <citation>Louie JC, Markovic TP, Ross GP, Foote D, Brand-Miller JC. Timing of peak blood glucose after breakfast meals of different glycemic index in women with gestational diabetes. Nutrients. 2012 Dec 21;5(1):1-9. doi: 10.3390/nu5010001.</citation>
    <PMID>23344248</PMID>
  </reference>
  <reference>
    <citation>Moses RG, Barker M, Winter M, Petocz P, Brand-Miller JC. Can a low-glycemic index diet reduce the need for insulin in gestational diabetes mellitus? A randomized trial. Diabetes Care. 2009 Jun;32(6):996-1000. doi: 10.2337/dc09-0007. Epub 2009 Mar 11.</citation>
    <PMID>19279301</PMID>
  </reference>
  <reference>
    <citation>Grant SM, Wolever TM, O'Connor DL, Nisenbaum R, Josse RG. Effect of a low glycaemic index diet on blood glucose in women with gestational hyperglycaemia. Diabetes Res Clin Pract. 2011 Jan;91(1):15-22. doi: 10.1016/j.diabres.2010.09.002. Epub 2010 Nov 20.</citation>
    <PMID>21094553</PMID>
  </reference>
  <reference>
    <citation>Moses RG, Luebcke M, Davis WS, Coleman KJ, Tapsell LC, Petocz P, Brand-Miller JC. Effect of a low-glycemic-index diet during pregnancy on obstetric outcomes. Am J Clin Nutr. 2006 Oct;84(4):807-12. doi: 10.1093/ajcn/84.4.807.</citation>
    <PMID>17023707</PMID>
  </reference>
  <reference>
    <citation>Perichart-Perera O, Balas-Nakash M, Rodriguez-Cano A, Legorreta-Legorreta J, Parra-Covarrubias A, Vadillo-Ortega F. Low Glycemic Index Carbohydrates versus All Types of Carbohydrates for Treating Diabetes in Pregnancy: A Randomized Clinical Trial to Evaluate the Effect of Glycemic Control. Int J Endocrinol. 2012;2012:296017. doi: 10.1155/2012/296017. Epub 2012 Nov 29.</citation>
    <PMID>23251152</PMID>
  </reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>November 4, 2018</study_first_submitted>
  <study_first_submitted_qc>January 9, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 14, 2019</study_first_posted>
  <last_update_submitted>January 23, 2019</last_update_submitted>
  <last_update_submitted_qc>January 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universiti Putra Malaysia</investigator_affiliation>
    <investigator_full_name>Barakatun Nisak Bt Mohd Yusof</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Gestational Diabetes Mellitus</keyword>
  <keyword>Glycemic index</keyword>
  <keyword>Metabolic Response</keyword>
  <keyword>Pregnancy Outcomes</keyword>
  <keyword>Glycemic control</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>
  <!-- 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/NCT03801824
org study id: 5450647
nct id: NCT03801824
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to determine whether glycemic index is effective in the
      treatment of maternal glycemia and pregnancy outcomes in women with Gestational Diabetes
      Mellitus.
1. This research is divided into 2, that are study I and study II

        1. Study I, is to determine the long-term effects of intervention (low GI and SNT) on
           maternal glycemia, pregnancy outcomes and postprandial metabolic markers in women with
           GDM

             -  A total of 110 women with confirmed diagnosis of GDM will be recruited

             -  They will be randomized either to receive low GI (n=55) or Standard Nutrition
                Therapy (SNT; n=55)

             -  The intervention will be started as soon as the women being diagnosed with GDM and
                they will be followed-up every month until delivery and up to the 3-month
                postpartum.

             -  The primary outcome measures include glycemic control parameters as assessed by
                fasting and postprandial glycemia, fructosamine, HbA1c, insulin level and
                requirement for insulin treatment.

             -  Secondary outcomes include lipid profile, weight gain, measures of postprandial
                metabolic response (free fatty acid and triglyceride), pregnancy outcomes, and
                overall improvement in postpartum metabolic parameters.

        2. Study II, a sub-Mixed-meal Tolerant Test (MTT) study will be conducted to determine
           postprandial glycemic and metabolic responses before and after 4-weeks of intensive
           intervention

             -  During the 4-weeks of intensive intervention, the subjects will receive
                individualise counseling and daily food supply regarding the allocated study group.

             -  A minimum of 19 subjects from a pool of 110 subjects who is participated in the
                intervention study will be recruited.

             -  The MTT procedure is similar to the oral glucose tolerant test (OGTT) but the
                subject will be asked to consume the real mixed meals representing low and high GI
                foods rather than oral glucose solution.

             -  Subject will be asked to consume the test meal (either low or high GI foods) and
                the blood will be sampled before and after consuming the test meal in two different
                occasions with 1-week wash-out period.

             -  After one month of intensive intervention, 19 subjects from each arm will undergo
                the final HGI meal tolerant test (MTT3) and the same procedure of MTT 1 and 2

             -  Approximately 32μl of capillary blood by finger-prick will be obtained 7 times per
                MTT session, which is every 30 minutes thereafter to complete 3-h postprandial meal
                for each set of meal tests.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Post meal blood glucose level
time frame: 12 weeks
description: Average blood glucose profiles after breakfast, lunch and dinner measured using capillary blood glucose at home
measure: Level of Triglycerides
time frame: 12 weeks
description: Changes in Fasting Triglycerides
measure: Level of glycemic control
time frame: 4 weeks
description: Changes in Fructosamine
measure: Maternal weight gain
time frame: 12 weeks
description: Changes in total weight gain based on Institute of Medicine (IOM) recommendations
measure: Level of post-meal blood glucose
time frame: 3 hour post-prandial
description: Changes in post-meal blood glucose level
arm group label: Standard Nutrition Therapy
arm group type: Active Comparator
description: Subjects in this group receive a standard nutrition therapy based on local guidelines that is usually high in fibre with moderate to high glycemic index food
arm group label: Low Glycemic Index
arm group type: Experimental
description: Subjects in this group receive intervention on low glycemic index foods
intervention type: Other
intervention name: Standard Nutrition Therapy
description: Subjects will be advised on standard diet appropriate for the management of Gestational Diabetes Mellitus (GDM) designed to be high in fiber and have moderate to high dietary glycemic index
arm group label: Standard Nutrition Therapy
intervention type: Other
intervention name: Low Glycemic Index
description: Subjects will be advised to eat low glycemic index foods
arm group label: Low Glycemic Index
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Barakatun-Nisak Mohd Yusof, PhD
role: Principal Investigator
affiliation: Universiti Putra Malaysia
facility: 
country: Malaysia
citation: Louie JC, Markovic TP, Ross GP, Foote D, Brand-Miller JC. Timing of peak blood glucose after breakfast meals of different glycemic index in women with gestational diabetes. Nutrients. 2012 Dec 21;5(1):1-9. doi: 10.3390/nu5010001.
PMID: 23344248
citation: Moses RG, Barker M, Winter M, Petocz P, Brand-Miller JC. Can a low-glycemic index diet reduce the need for insulin in gestational diabetes mellitus? A randomized trial. Diabetes Care. 2009 Jun;32(6):996-1000. doi: 10.2337/dc09-0007. Epub 2009 Mar 11.
PMID: 19279301
citation: Grant SM, Wolever TM, O'Connor DL, Nisenbaum R, Josse RG. Effect of a low glycaemic index diet on blood glucose in women with gestational hyperglycaemia. Diabetes Res Clin Pract. 2011 Jan;91(1):15-22. doi: 10.1016/j.diabres.2010.09.002. Epub 2010 Nov 20.
PMID: 21094553
citation: Moses RG, Luebcke M, Davis WS, Coleman KJ, Tapsell LC, Petocz P, Brand-Miller JC. Effect of a low-glycemic-index diet during pregnancy on obstetric outcomes. Am J Clin Nutr. 2006 Oct;84(4):807-12. doi: 10.1093/ajcn/84.4.807.
PMID: 17023707
citation: Perichart-Perera O, Balas-Nakash M, Rodriguez-Cano A, Legorreta-Legorreta J, Parra-Covarrubias A, Vadillo-Ortega F. Low Glycemic Index Carbohydrates versus All Types of Carbohydrates for Treating Diabetes in Pregnancy: A Randomized Clinical Trial to Evaluate the Effect of Glycemic Control. Int J Endocrinol. 2012;2012:296017. doi: 10.1155/2012/296017. Epub 2012 Nov 29.
PMID: 23251152
responsible party type: Principal Investigator
investigator affiliation: Universiti Putra Malaysia
investigator full name: Barakatun Nisak Bt Mohd Yusof
investigator title: Associate Professor
mesh term: Diabetes, Gestational
mesh term: Diabetes Mellitus