<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/NCT03038282</url>
  </required_header>
  <id_info>
    <org_study_id>1R01TCR012617</org_study_id>
    <nct_id>NCT03038282</nct_id>
  </id_info>
  <brief_title>Effects of Chromium on Insulin Resistance in Alzheimer Disease Patients</brief_title>
  <official_title>Effects of Chromium on Insulin Resistance in Alzheimer Disease Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Metabolic Therapy Inc.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Metabolic Therapy Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The effect of Chromium to improve glucose levels in Alzheimer Disease (AD) is controversial.&#xD;
      The hypothesis of the study is to evaluate the effect of supplementing the AD individuals&#xD;
      with Chromium combined with exercise and assessing the effect of the supplementation on&#xD;
      glucose metabolism.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Chromium is an essential nutrient required for optimal insulin activity and normal&#xD;
      carbohydrate and lipid metabolism. Beyond its nutritional effects, dietary supplement of&#xD;
      chromium causes beneficial outcomes against several diseases, in particular&#xD;
      diabetes-associated complications such as Alzheimer Disease. Common forms include chromium&#xD;
      chloride, chromium nicotinate, and chromium picolinate.&#xD;
&#xD;
      The argument for chromium supplementation relies on evidence from case reports of resolution&#xD;
      of diabetic symptoms refractory to insulin via chromium added to total parenteral nutrition,&#xD;
      and experiments in which animals deficient in chromium exhibited impaired glucose metabolism.&#xD;
&#xD;
      Chromium may influence glucose metabolism by increasing the number of insulin receptors or by&#xD;
      binding insulin to receptors. The US Food and Drug Administration concludes that, based on&#xD;
      recent studies, chromium picolinate may reduce the risk of insulin resistance and therefore&#xD;
      may reduce the risk of type 2 diabetes.&#xD;
&#xD;
      A number of systematic reviews and meta-analyses have been conducted to determine the effect&#xD;
      of chromium on glycemic control, although large, quality trials are limited. The majority of&#xD;
      studies have found no effect on measured outcomes, with a few studies contributing to the&#xD;
      positive observed effects. Variations of preparations used in the trials and study conditions&#xD;
      make generalization of the results difficult.&#xD;
&#xD;
      In order to provide a comprehensive clinical evaluation of the effects of Chromium in AD&#xD;
      patients, we will conduct a double-blinded and placebo-controlled trial in subjects with AD.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">February 20, 2017</start_date>
  <completion_date type="Anticipated">October 20, 2019</completion_date>
  <primary_completion_date type="Anticipated">August 20, 2019</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Participants, Investigator</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Insulin Resistance</measure>
    <time_frame>Change from Baseline to 12 weeks</time_frame>
    <description>Insulin action will be determined by insulin clamp and OGTT using deuterated glucose both before and after treatment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in chronic refractory mood disorders</measure>
    <time_frame>Change from Baseline to 12 weeks</time_frame>
    <description>To be measured using confirmatory factor analysis (CFA). CFA aggregates scores from across multiple subtests.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Alzheimer Disease</condition>
  <arm_group>
    <arm_group_label>Chromium Chloride</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants transdermal chromium chloride 50 to 600 mcg/day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Individual Exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Exercise 150 minutes per week (over 3 to 5 days) for 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants or participant's caregiver will be provided educational materials on starting an exercise program and instructions for the application of transdermal chromium chloride, but will receive no formal support for their exercise program.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Chromium Chloride</intervention_name>
    <description>Transdermal chromium chloride 50 to 600 mcg/day.</description>
    <arm_group_label>Chromium Chloride</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Individual Exercise</intervention_name>
    <description>Participants will engage in 150 minutes of exercise over 3-5 days per week for 12 weeks</description>
    <arm_group_label>Individual Exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Outpatients with a diagnosis of Alzheimer's disease.&#xD;
&#xD;
          -  Exhibiting an onset and progression of cognitive dysfunction during at least 3 months&#xD;
             prior to the screening period.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with neurodegenerative diseases other than Alzheimer's disease.&#xD;
&#xD;
          -  Patients with cognitive dysfunction due to cerebral damage resulting from a lack of&#xD;
             oxygen, a brain injury, etc.&#xD;
&#xD;
          -  Patients with clinically significant cardiovascular disease.&#xD;
&#xD;
          -  Patients with history of clinically-evident stroke.&#xD;
&#xD;
          -  Patients with history of cancer in the last 5 years.&#xD;
&#xD;
          -  Patients with clinically-significant systemic illness that may affect safety or&#xD;
             completion of the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andreana Haley, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Texas - Austin</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Dewey C Brown II, PhD</last_name>
    <phone>2145174004</phone>
  </overall_contact>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 26, 2017</study_first_submitted>
  <study_first_submitted_qc>January 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 31, 2017</study_first_posted>
  <last_update_submitted>January 27, 2017</last_update_submitted>
  <last_update_submitted_qc>January 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 31, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alzheimer Disease</mesh_term>
    <mesh_term>Insulin Resistance</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chromium</mesh_term>
    <mesh_term>Chromous chloride</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Sharing data will be available upon written request.</ipd_description>
  </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/NCT03038282
org study id: 1R01TCR012617
nct id: NCT03038282
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
The effect of Chromium to improve glucose levels in Alzheimer Disease (AD) is controversial.
      The hypothesis of the study is to evaluate the effect of supplementing the AD individuals
      with Chromium combined with exercise and assessing the effect of the supplementation on
      glucose metabolism.
Chromium is an essential nutrient required for optimal insulin activity and normal
      carbohydrate and lipid metabolism. Beyond its nutritional effects, dietary supplement of
      chromium causes beneficial outcomes against several diseases, in particular
      diabetes-associated complications such as Alzheimer Disease. Common forms include chromium
      chloride, chromium nicotinate, and chromium picolinate.

      The argument for chromium supplementation relies on evidence from case reports of resolution
      of diabetic symptoms refractory to insulin via chromium added to total parenteral nutrition,
      and experiments in which animals deficient in chromium exhibited impaired glucose metabolism.

      Chromium may influence glucose metabolism by increasing the number of insulin receptors or by
      binding insulin to receptors. The US Food and Drug Administration concludes that, based on
      recent studies, chromium picolinate may reduce the risk of insulin resistance and therefore
      may reduce the risk of type 2 diabetes.

      A number of systematic reviews and meta-analyses have been conducted to determine the effect
      of chromium on glycemic control, although large, quality trials are limited. The majority of
      studies have found no effect on measured outcomes, with a few studies contributing to the
      positive observed effects. Variations of preparations used in the trials and study conditions
      make generalization of the results difficult.

      In order to provide a comprehensive clinical evaluation of the effects of Chromium in AD
      patients, we will conduct a double-blinded and placebo-controlled trial in subjects with AD.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Participants, Investigator
measure: Insulin Resistance
time frame: Change from Baseline to 12 weeks
description: Insulin action will be determined by insulin clamp and OGTT using deuterated glucose both before and after treatment.
measure: Change in chronic refractory mood disorders
time frame: Change from Baseline to 12 weeks
description: To be measured using confirmatory factor analysis (CFA). CFA aggregates scores from across multiple subtests.
arm group label: Chromium Chloride
arm group type: Experimental
description: Participants transdermal chromium chloride 50 to 600 mcg/day.
arm group label: Individual Exercise
arm group type: Experimental
description: Exercise 150 minutes per week (over 3 to 5 days) for 12 weeks.
arm group label: Control Group
arm group type: No Intervention
description: Participants or participant's caregiver will be provided educational materials on starting an exercise program and instructions for the application of transdermal chromium chloride, but will receive no formal support for their exercise program.
intervention type: Dietary Supplement
intervention name: Chromium Chloride
description: Transdermal chromium chloride 50 to 600 mcg/day.
arm group label: Chromium Chloride
intervention type: Other
intervention name: Individual Exercise
description: Participants will engage in 150 minutes of exercise over 3-5 days per week for 12 weeks
arm group label: Individual Exercise
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Andreana Haley, PhD
role: Principal Investigator
affiliation: University of Texas - Austin
last name: Dewey C Brown II, PhD
phone: 2145174004
responsible party type: Sponsor
mesh term: Alzheimer Disease
mesh term: Insulin Resistance
mesh term: Chromium
mesh term: Chromous chloride
sharing ipd: Undecided
ipd description: Sharing data will be available upon written request.