<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/NCT02244879</url>
  </required_header>
  <id_info>
    <org_study_id>RF-2010-2313155</org_study_id>
    <nct_id>NCT02244879</nct_id>
  </id_info>
  <brief_title>Effects of Resveratrol on Inflammation in Type 2 Diabetic Patients</brief_title>
  <official_title>Effects of Resveratrol on Inflammation in Type 2 Diabetic Patients. A Double-blind Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Turin, Italy</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministry of Health, Italy</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Turin, Italy</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This research will investigate the effect of resveratrol on inflammatory mediators in type 2&#xD;
      diabetic patients in vivo.&#xD;
&#xD;
      The investigators will also investigate the hypothesis that resveratrol has an antioxidant&#xD;
      activity, improves insulin sensitivity and lipid pattern, down-regulates bone-turnover.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Despite a large body of evidence demonstrating promising effects of resveratrol in rodents,&#xD;
      human studies are still lacking and both preventive and therapeutic value of resveratrol in&#xD;
      humans remains to be elucidated. The published evidence is not sufficiently strong to&#xD;
      recommend for the administration of resveratrol to humans, beyond dietary sources. On the&#xD;
      other hand, animal data are promising in prevention of various cancer types, coronary heart&#xD;
      diseases and diabetes which strongly indicate the need for human clinical trials.&#xD;
&#xD;
      Furthermore, data are lacking either about safety during long-term administration, or on the&#xD;
      efficacy of resveratrol administration in patients with chronic illnesses, such as diabetes&#xD;
      mellitus.&#xD;
&#xD;
      The main objective of this study is to investigate the effect of resveratrol on inflammatory&#xD;
      mediators in type 2 diabetic patients in vivo.&#xD;
&#xD;
      This research will investigate the hypothesis that resveratrol, when given orally to type 2&#xD;
      diabetic subjects for 24 weeks induces a decrease in values of high-sensitivity CRP&#xD;
      (C-reactive protein) (primary outcome measure), IL-6 (Interleukin-6), PTX3 (pentraxin 3).&#xD;
&#xD;
      The investigators will also investigate the hypothesis that resveratrol has an antioxidant&#xD;
      activity, improves insulin sensitivity and lipid pattern, down-regulates bone-turnover.&#xD;
      Secondary outcomes are therefore variations in the following variables: TAS (total&#xD;
      antioxidant status), glycemia, glycated hemoglobin (HbA1c), Homeostasis model assessment of&#xD;
      insulin resistance (HOMA-IR), total and HDL-cholesterol, triglycerides, adiponectin, body&#xD;
      composition (evaluated by Dual-emission X-ray absorptiometry DXA-), bone mineral density&#xD;
      (DXA).&#xD;
&#xD;
      Finally, the investigators are interested in evaluating efficacy, safety and tolerability of&#xD;
      two different dosages of resveratrol: 500 mg/day and 40 mg/day.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2013</start_date>
  <completion_date type="Actual">February 2016</completion_date>
  <primary_completion_date type="Actual">February 2016</primary_completion_date>
  <phase>Phase 3</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>C reactive protein (CRP)</measure>
    <time_frame>up to 25 months</time_frame>
    <description>To investigate changes from baseline in blood concentrations of high-sensitivity CRP after six months of treatment with either resveratrol at different dosages or placebo</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Metabolic and oxidative markers</measure>
    <time_frame>up to 25 months</time_frame>
    <description>To evaluate before-after changes in the concentrations of the following: Interleukin 6, Pentraxin-3, total antioxidant status, fasting glucose, insulin, glycated hemoglobin, total and HDL-cholesterol, triglycerides, adiponectin.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>body composition and bone mineral density</measure>
    <time_frame>up to 25 months</time_frame>
    <description>To evaluate before-after change in bone mineral density and body composition by Dual-emission X-ray absorptiometry</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">192</enrollment>
  <condition>Type 2 Diabetes Mellitus</condition>
  <condition>Inflammation</condition>
  <condition>Insulin Resistance</condition>
  <condition>Other Disorders of Bone Density and Structure</condition>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>In this arm, 64 patients will receive a tablet of placebo once/day for 6 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>resveratrol 40</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In this arm, 64 patients will receive a tablet of 40mg resveratrol once/day for 6 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>resveratrol 500</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In this arm, 64 patients will receive a tablet of 500 mg resveratrol once/day for 6 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>resveratrol</intervention_name>
    <description>arm resveratrol 500: 6 months of resveratrol 500 mg/day arm resveratrol 40: 6 months of resveratrol 40 mg/day</description>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_label>resveratrol 40</arm_group_label>
    <arm_group_label>resveratrol 500</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. 35 years of age and older&#xD;
&#xD;
          2. Type 2 diabetes with body mass index (BMI)&lt;35 kg/m2&#xD;
&#xD;
          3. Subjects on hypoglycemic agents other than insulin&#xD;
&#xD;
          4. Willing to give written informed consent and able to understand, to participate in and&#xD;
             to comply with the study requirements.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subjects on any antioxidant medication&#xD;
&#xD;
          2. Patient on non-steroidal anti-inflammatory drug, steroids or insulin&#xD;
&#xD;
          3. On any agent with significant antioxidant properties&#xD;
&#xD;
          4. History of drug or alcohol abuse&#xD;
&#xD;
          5. Liver or kidney diseases&#xD;
&#xD;
          6. Any life threatening diseases&#xD;
&#xD;
          7. Allergy to peanuts, grapes, wine, mulberries&#xD;
&#xD;
          8. Pregnant women&#xD;
&#xD;
          9. Coronary event or procedure (myocardial infarction, unstable angina, coronary artery&#xD;
             bypass surgery or coronary angioplasty) in the previous four Weeks&#xD;
&#xD;
         10. Subjects on anticoagulants&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Simona Bo, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Turin, Italy</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Turin</name>
      <address>
        <city>Turin</city>
        <state>IT</state>
        <zip>10126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>March 2016</verification_date>
  <study_first_submitted>September 15, 2014</study_first_submitted>
  <study_first_submitted_qc>September 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2014</study_first_posted>
  <last_update_submitted>March 6, 2016</last_update_submitted>
  <last_update_submitted_qc>March 6, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 8, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Turin, Italy</investigator_affiliation>
    <investigator_full_name>Simona Bo</investigator_full_name>
    <investigator_title>Dr</investigator_title>
  </responsible_party>
  <keyword>resveratrol</keyword>
  <keyword>type 2 diabetes mellitus</keyword>
  <keyword>inflammation</keyword>
  <keyword>insulin resistance</keyword>
  <keyword>body composition</keyword>
  <keyword>bone mass</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bone Diseases</mesh_term>
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
    <mesh_term>Insulin Resistance</mesh_term>
    <mesh_term>Inflammation</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Resveratrol</mesh_term>
  </intervention_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/NCT02244879
org study id: RF-2010-2313155
nct id: NCT02244879
lead sponsor: 
collaborator: 
has dmc: No
This research will investigate the effect of resveratrol on inflammatory mediators in type 2
      diabetic patients in vivo.

      The investigators will also investigate the hypothesis that resveratrol has an antioxidant
      activity, improves insulin sensitivity and lipid pattern, down-regulates bone-turnover.
Despite a large body of evidence demonstrating promising effects of resveratrol in rodents,
      human studies are still lacking and both preventive and therapeutic value of resveratrol in
      humans remains to be elucidated. The published evidence is not sufficiently strong to
      recommend for the administration of resveratrol to humans, beyond dietary sources. On the
      other hand, animal data are promising in prevention of various cancer types, coronary heart
      diseases and diabetes which strongly indicate the need for human clinical trials.

      Furthermore, data are lacking either about safety during long-term administration, or on the
      efficacy of resveratrol administration in patients with chronic illnesses, such as diabetes
      mellitus.

      The main objective of this study is to investigate the effect of resveratrol on inflammatory
      mediators in type 2 diabetic patients in vivo.

      This research will investigate the hypothesis that resveratrol, when given orally to type 2
      diabetic subjects for 24 weeks induces a decrease in values of high-sensitivity CRP
      (C-reactive protein) (primary outcome measure), IL-6 (Interleukin-6), PTX3 (pentraxin 3).

      The investigators will also investigate the hypothesis that resveratrol has an antioxidant
      activity, improves insulin sensitivity and lipid pattern, down-regulates bone-turnover.
      Secondary outcomes are therefore variations in the following variables: TAS (total
      antioxidant status), glycemia, glycated hemoglobin (HbA1c), Homeostasis model assessment of
      insulin resistance (HOMA-IR), total and HDL-cholesterol, triglycerides, adiponectin, body
      composition (evaluated by Dual-emission X-ray absorptiometry DXA-), bone mineral density
      (DXA).

      Finally, the investigators are interested in evaluating efficacy, safety and tolerability of
      two different dosages of resveratrol: 500 mg/day and 40 mg/day.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: C reactive protein (CRP)
time frame: up to 25 months
description: To investigate changes from baseline in blood concentrations of high-sensitivity CRP after six months of treatment with either resveratrol at different dosages or placebo
measure: Metabolic and oxidative markers
time frame: up to 25 months
description: To evaluate before-after changes in the concentrations of the following: Interleukin 6, Pentraxin-3, total antioxidant status, fasting glucose, insulin, glycated hemoglobin, total and HDL-cholesterol, triglycerides, adiponectin.
measure: body composition and bone mineral density
time frame: up to 25 months
description: To evaluate before-after change in bone mineral density and body composition by Dual-emission X-ray absorptiometry
arm group label: placebo
arm group type: Placebo Comparator
description: In this arm, 64 patients will receive a tablet of placebo once/day for 6 months
arm group label: resveratrol 40
arm group type: Experimental
description: In this arm, 64 patients will receive a tablet of 40mg resveratrol once/day for 6 months
arm group label: resveratrol 500
arm group type: Experimental
description: In this arm, 64 patients will receive a tablet of 500 mg resveratrol once/day for 6 months
intervention type: Dietary Supplement
intervention name: resveratrol
description: arm resveratrol 500: 6 months of resveratrol 500 mg/day arm resveratrol 40: 6 months of resveratrol 40 mg/day
arm group label: placebo
arm group label: resveratrol 40
arm group label: resveratrol 500
criteria: 
gender: All
minimum age: 35 Years
maximum age: 85 Years
healthy volunteers: No
last name: Simona Bo, MD
role: Principal Investigator
affiliation: University of Turin, Italy
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: University of Turin, Italy
investigator full name: Simona Bo
investigator title: Dr
mesh term: Bone Diseases
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Insulin Resistance
mesh term: Inflammation
mesh term: Resveratrol