<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/NCT02260895</url>
  </required_header>
  <id_info>
    <org_study_id>HSC-MH-14-0667</org_study_id>
    <nct_id>NCT02260895</nct_id>
  </id_info>
  <brief_title>Almond Effects on Glucose Intolerance Study</brief_title>
  <acronym>AEGIS</acronym>
  <official_title>Almond Effects on Glucose Intolerance Study (AEGIS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Memorial Hermann Health System</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Texas Academy of Family Physicians Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Memorial Hermann Health System</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Diabetes is a major cause of morbidity and mortality worldwide. Prevention of diabetes is an&#xD;
      important goal. The progression from impaired glucose tolerance to diabetes is thought to be&#xD;
      promoted by the toxic effects of hyperglycemia on pancreatic beta cells. One of the main&#xD;
      defects causing postprandial hyperglycemia in individuals with impaired glucose tolerance is&#xD;
      reduced first phase (immediate) insulin release. The investigators hypothesis is that&#xD;
      consuming a nutritional preload--a low-calorie, nutritionally balanced snack--30 minutes&#xD;
      before ingesting a carbohydrate load, will moderate the hyperglycemic response to subsequent&#xD;
      carbohydrate challenge and reduce glucotoxicity by stimulating insulin release and synthesis.&#xD;
&#xD;
      The aim of this study is to test this hypothesis by comparing the standard 75-gram, two-hour&#xD;
      oral glucose tolerance test (OGTT) response of 30 fasting adults who have impaired glucose&#xD;
      tolerance to their OGTT response when the test is preceded by ½ ounce (14 grams) of&#xD;
      dry-roasted, unsalted almonds. A pre-load interval of 30 minutes was chosen so that the peak&#xD;
      of phase 2 (delayed) insulin response to the pre-load (45-60 minutes) would coincide with the&#xD;
      timeframe of the steepest OGTT rise in glucose (15 to 30 minutes post challenge).&#xD;
&#xD;
      The investigators hypothesize that the one-hour OGTT glucose level will be approximately 40&#xD;
      mg/dl lower when participants consume the pre-OGTT almond snack, compared to their one-hour&#xD;
      glucose level on the standard two-hour OGTT. The two-hour OGTT glucose level is unlikely to&#xD;
      show a statistically significant difference between the almond pre-test snack and control&#xD;
      standard OGTT conditions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will be conducted at Physicians at Sugar Creek (PSC)-the model family practice&#xD;
      center for the Memorial Family Medicine Residency Program. The ethnicity of PSC patients is&#xD;
      approximately 30% non-Hispanic white, 30% Hispanic, 30% African-American, and 10% Asian.&#xD;
&#xD;
      Potential participants will be identified by searching PSC electronic medical records&#xD;
      (Centricity) to find adults aged 18-75 with impaired glucose tolerance, without diabetes&#xD;
      (one-hour oral glucose tolerance test result &gt;160 md/dl and two-hour OGTT result &lt;200 mg/dl),&#xD;
      without hypoglycemic medications and corticosteroids on their active medications list, and&#xD;
      without almond allergy on their allergy list.&#xD;
&#xD;
      Recruitment flyers will be posted in the clinic to encourage interested individuals to&#xD;
      contact the investigators about their potential study eligibility. The investigators will&#xD;
      also approach previously identified potentially eligible patients during routine clinical&#xD;
      visits in the clinic, to elicit their interest in participating in the study. Those&#xD;
      expressing interest will be scheduled for an intake visit with an investigator, to further&#xD;
      ascertain their eligibility and invite eligible individuals to take part in the study.&#xD;
      Interested eligible individuals who render verbal and written informed consent will then be&#xD;
      instructed in the study protocol and scheduled for their first data gathering visit.&#xD;
&#xD;
      Each participant will be scheduled to undergo two 2-hour oral glucose tolerance tests (OGTT),&#xD;
      starting between 7:00 and 9:30 a.m., one to four weeks apart. Test A will be a standard&#xD;
      75-gram OGTT. Test B will be an OGTT that will begin 30 minutes after ingestion of a&#xD;
      low-carbohydrate pre-load &quot;snack&quot; consisting of 1/2 oz (14 grams) of unsalted, dry-roasted&#xD;
      almonds (12 average size almonds). Each participant will be given an 8-ounce glass of water&#xD;
      to drink with the almonds. Participants will be randomized to one of two test sequences (A-B&#xD;
      or B-A), to control for sequence effects on results.&#xD;
&#xD;
      To minimize variability of OGTT results, participants will be asked to eat as they usually do&#xD;
      throughout the study. Participants will be asked to refrain from vigorous physical activity&#xD;
      for 8 hours prior to each OGTT and to minimize their physical activity during each OGTT.&#xD;
      Participants will complete a Perceived Stress Scale and a 24-hour food, alcohol, and activity&#xD;
      recall for the day before each OGTT to analyze potential confounding effects of stress, diet,&#xD;
      alcohol, and physical activity on the results.&#xD;
&#xD;
      Blood sampling will be done for serial measurements of plasma glucose at time-zero, and at&#xD;
      60-minute intervals for two hours after each 75-gram glucose load. An investigator will&#xD;
      monitor the timing of each blood draw closely to ensure timeliness. Blood will be drawn by&#xD;
      one of two phlebotomists in the on-site laboratory and sent to the Memorial Hermann Southwest&#xD;
      Hospital or Quest Lab (the latter only for the control OGTT, for patients whose insurance&#xD;
      requires this) for analysis. The glucose results will be reported electronically to the&#xD;
      patient's medical record in the routine manner for blood test results.&#xD;
&#xD;
      Investigators will abstract the glucose results from the patients' electronic medical records&#xD;
      for data analysis purposes. The primary dependent variable is the mean difference in plasma&#xD;
      glucose (fasting to 1-hr post 75-g glucose challenge, with vs. without snack. The secondary&#xD;
      dependent variable is the mean difference in plasma glucose (fasting to 2-hr post 75-g&#xD;
      glucose challenge, with vs. without snack). Student's t test will be used to analyze the&#xD;
      differences between the standard 75-g OGTT results and the OGTT results following the almond&#xD;
      pre-test snack. Analysis of variance will be used to analyze the data for confounding effects&#xD;
      of ethnicity, gender, body mass index (BMI), and pre-test food and alcohol intake, physical&#xD;
      activity, and perceived stress level.&#xD;
&#xD;
      Patients will receive their individual results and an investigator-generated evaluative&#xD;
      commentary in a routine &quot;lab letter&quot;. The results letter will be forwarded to each patient's&#xD;
      primary care provider for review and appropriate clinical follow-up. Patients' results will&#xD;
      be communicated scientifically in an aggregate manner, with no individual identifying&#xD;
      information, to maintain patient confidentiality.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>December 2014</start_date>
  <completion_date type="Anticipated">March 2016</completion_date>
  <primary_completion_date type="Anticipated">March 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>One-hour OGTT result</measure>
    <time_frame>60 minutes into 2-hour oral glucose tolerance test</time_frame>
    <description>One-hour oral glucose tolerance test result</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Two-hour OGTT result</measure>
    <time_frame>120 minutes into 2-hour oral glucose tolerance test</time_frame>
    <description>Two-hour oral glucose tolerance test result (at 2 hours)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Prediabetes</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard 2-hour 75-gram oral glucose tolerance test</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Almond Pre-test snack</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1/2 ounce (14 g) almond snack 30 minutes prior to a 2-hour 75-gram oral glucose tolerance test</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Almond pre-test snack</intervention_name>
    <description>unsalted, dry-roasted almonds, 1/2 oz (14 g), ingested 30 minutes prior to the start of a two-hour oral glucose tolerance test</description>
    <arm_group_label>Almond Pre-test snack</arm_group_label>
    <other_name>unsalted, dry-roasted almonds</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  History of abnormal 1-hour OGTT result (&gt;160 mg/dL) or 2-hour OGTT (&gt;140)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of a diagnosis of diabetes&#xD;
&#xD;
          -  History of a 2-hour OGTT result &gt;200 mg/dL&#xD;
&#xD;
          -  History of a fasting glucose &gt;125 mg/dL&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael A Crouch, MD, MSPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Memorial Hermann Health System</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Physicians at Sugar Creek - Memorial Family Medicine Residency Program</name>
      <address>
        <city>Sugar Land</city>
        <state>Texas</state>
        <zip>77478</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2016</verification_date>
  <study_first_submitted>October 6, 2014</study_first_submitted>
  <study_first_submitted_qc>October 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 9, 2014</study_first_posted>
  <last_update_submitted>March 15, 2016</last_update_submitted>
  <last_update_submitted_qc>March 15, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 16, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Memorial Hermann Health System</investigator_affiliation>
    <investigator_full_name>Michael A. Crouch</investigator_full_name>
    <investigator_title>Research Director, Memorial Family Medicine Residency Program</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glucose Intolerance</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/NCT02260895
org study id: HSC-MH-14-0667
nct id: NCT02260895
lead sponsor: 
collaborator: 
has dmc: No
Diabetes is a major cause of morbidity and mortality worldwide. Prevention of diabetes is an
      important goal. The progression from impaired glucose tolerance to diabetes is thought to be
      promoted by the toxic effects of hyperglycemia on pancreatic beta cells. One of the main
      defects causing postprandial hyperglycemia in individuals with impaired glucose tolerance is
      reduced first phase (immediate) insulin release. The investigators hypothesis is that
      consuming a nutritional preload--a low-calorie, nutritionally balanced snack--30 minutes
      before ingesting a carbohydrate load, will moderate the hyperglycemic response to subsequent
      carbohydrate challenge and reduce glucotoxicity by stimulating insulin release and synthesis.

      The aim of this study is to test this hypothesis by comparing the standard 75-gram, two-hour
      oral glucose tolerance test (OGTT) response of 30 fasting adults who have impaired glucose
      tolerance to their OGTT response when the test is preceded by ½ ounce (14 grams) of
      dry-roasted, unsalted almonds. A pre-load interval of 30 minutes was chosen so that the peak
      of phase 2 (delayed) insulin response to the pre-load (45-60 minutes) would coincide with the
      timeframe of the steepest OGTT rise in glucose (15 to 30 minutes post challenge).

      The investigators hypothesize that the one-hour OGTT glucose level will be approximately 40
      mg/dl lower when participants consume the pre-OGTT almond snack, compared to their one-hour
      glucose level on the standard two-hour OGTT. The two-hour OGTT glucose level is unlikely to
      show a statistically significant difference between the almond pre-test snack and control
      standard OGTT conditions.
The study will be conducted at Physicians at Sugar Creek (PSC)-the model family practice
      center for the Memorial Family Medicine Residency Program. The ethnicity of PSC patients is
      approximately 30% non-Hispanic white, 30% Hispanic, 30% African-American, and 10% Asian.

      Potential participants will be identified by searching PSC electronic medical records
      (Centricity) to find adults aged 18-75 with impaired glucose tolerance, without diabetes
      (one-hour oral glucose tolerance test result >160 md/dl and two-hour OGTT result <200 mg/dl),
      without hypoglycemic medications and corticosteroids on their active medications list, and
      without almond allergy on their allergy list.

      Recruitment flyers will be posted in the clinic to encourage interested individuals to
      contact the investigators about their potential study eligibility. The investigators will
      also approach previously identified potentially eligible patients during routine clinical
      visits in the clinic, to elicit their interest in participating in the study. Those
      expressing interest will be scheduled for an intake visit with an investigator, to further
      ascertain their eligibility and invite eligible individuals to take part in the study.
      Interested eligible individuals who render verbal and written informed consent will then be
      instructed in the study protocol and scheduled for their first data gathering visit.

      Each participant will be scheduled to undergo two 2-hour oral glucose tolerance tests (OGTT),
      starting between 7:00 and 9:30 a.m., one to four weeks apart. Test A will be a standard
      75-gram OGTT. Test B will be an OGTT that will begin 30 minutes after ingestion of a
      low-carbohydrate pre-load "snack" consisting of 1/2 oz (14 grams) of unsalted, dry-roasted
      almonds (12 average size almonds). Each participant will be given an 8-ounce glass of water
      to drink with the almonds. Participants will be randomized to one of two test sequences (A-B
      or B-A), to control for sequence effects on results.

      To minimize variability of OGTT results, participants will be asked to eat as they usually do
      throughout the study. Participants will be asked to refrain from vigorous physical activity
      for 8 hours prior to each OGTT and to minimize their physical activity during each OGTT.
      Participants will complete a Perceived Stress Scale and a 24-hour food, alcohol, and activity
      recall for the day before each OGTT to analyze potential confounding effects of stress, diet,
      alcohol, and physical activity on the results.

      Blood sampling will be done for serial measurements of plasma glucose at time-zero, and at
      60-minute intervals for two hours after each 75-gram glucose load. An investigator will
      monitor the timing of each blood draw closely to ensure timeliness. Blood will be drawn by
      one of two phlebotomists in the on-site laboratory and sent to the Memorial Hermann Southwest
      Hospital or Quest Lab (the latter only for the control OGTT, for patients whose insurance
      requires this) for analysis. The glucose results will be reported electronically to the
      patient's medical record in the routine manner for blood test results.

      Investigators will abstract the glucose results from the patients' electronic medical records
      for data analysis purposes. The primary dependent variable is the mean difference in plasma
      glucose (fasting to 1-hr post 75-g glucose challenge, with vs. without snack. The secondary
      dependent variable is the mean difference in plasma glucose (fasting to 2-hr post 75-g
      glucose challenge, with vs. without snack). Student's t test will be used to analyze the
      differences between the standard 75-g OGTT results and the OGTT results following the almond
      pre-test snack. Analysis of variance will be used to analyze the data for confounding effects
      of ethnicity, gender, body mass index (BMI), and pre-test food and alcohol intake, physical
      activity, and perceived stress level.

      Patients will receive their individual results and an investigator-generated evaluative
      commentary in a routine "lab letter". The results letter will be forwarded to each patient's
      primary care provider for review and appropriate clinical follow-up. Patients' results will
      be communicated scientifically in an aggregate manner, with no individual identifying
      information, to maintain patient confidentiality.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: One-hour OGTT result
time frame: 60 minutes into 2-hour oral glucose tolerance test
description: One-hour oral glucose tolerance test result
measure: Two-hour OGTT result
time frame: 120 minutes into 2-hour oral glucose tolerance test
description: Two-hour oral glucose tolerance test result (at 2 hours)
arm group label: Control
arm group type: No Intervention
description: Standard 2-hour 75-gram oral glucose tolerance test
arm group label: Almond Pre-test snack
arm group type: Experimental
description: 1/2 ounce (14 g) almond snack 30 minutes prior to a 2-hour 75-gram oral glucose tolerance test
intervention type: Dietary Supplement
intervention name: Almond pre-test snack
description: unsalted, dry-roasted almonds, 1/2 oz (14 g), ingested 30 minutes prior to the start of a two-hour oral glucose tolerance test
arm group label: Almond Pre-test snack
other name: unsalted, dry-roasted almonds
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Michael A Crouch, MD, MSPH
role: Principal Investigator
affiliation: Memorial Hermann Health System
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Memorial Hermann Health System
investigator full name: Michael A. Crouch
investigator title: Research Director, Memorial Family Medicine Residency Program
mesh term: Glucose Intolerance