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+<?xml version="1.0" encoding="UTF-8"?>
+<clinical_study rank="139470">
+  <!-- This xml conforms to an XML Schema at:
+    https://clinicaltrials.gov/ct2/html/images/info/public.xsd
+ and an XML DTD at:
+    https://clinicaltrials.gov/ct2/html/images/info/public.dtd -->
+  <required_header>
+    <download_date>ClinicalTrials.gov processed this data on December 16, 2015</download_date>
+    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
+    <url>https://clinicaltrials.gov/show/NCT00809029</url>
+  </required_header>
+  <id_info>
+    <org_study_id>08/H1001/20</org_study_id>
+    <secondary_id>08DE001</secondary_id>
+    <nct_id>NCT00809029</nct_id>
+  </id_info>
+  <brief_title>The Influence Of GIP (Glucose-Dependent Insulinotropic Polypeptide) Infusion On Human Adipose Tissue: An In Vivo Study</brief_title>
+  <official_title>The Influence Of GIP (Glucose-Dependent Insulinotropic Polypeptide) Infusion On Hormone Sensitive Lipase, Lipoprotein Lipase And Adipokine Expression In Human Subcutaneous Adipose Tissue: An In Vivo Study</official_title>
+  <sponsors>
+    <lead_sponsor>
+      <agency>Aintree University Hospitals NHS Foundation Trust</agency>
+      <agency_class>Other</agency_class>
+    </lead_sponsor>
+  </sponsors>
+  <source>Aintree University Hospitals NHS Foundation Trust</source>
+  <oversight_info>
+    <authority>United Kingdom: Research Ethics Committee</authority>
+    <has_dmc>No</has_dmc>
+  </oversight_info>
+  <brief_summary>
+    <textblock>
+      Study part-1
+
+      GIP (glucose-dependent insulinotropic polypeptide) is one of the two main incretin hormones
+      secreted by specialized cells of the gastrointestinal tract in response to ingestion of
+      nutrients. Data emerging from studies in animal models and cultured human fat cells support
+      a physiological role for GIP in the adipose tissue metabolism which may contribute to the
+      pathogenesis of obesity.
+
+      The proposed study will shed more light on the interactions between gut hormones and adipose
+      tissue. For this pilot study, male subjects fulfilling the inclusion criteria will be given
+      GIP or placebo infusions in a randomized manner. Fat tissue biopsies will be obtained from
+      all subjects during both visits, once in the basal state (before the start of the
+      peptide/placebo infusion) and then repeated at the end of the period of infusion.
+
+      Study part-2
+
+      Surgery represents the most effective therapeutic modality for morbid obesity. Resolution of
+      type 2 diabetes mellitus (T2DM) has been consistently observed as an additional benefit of
+      surgical treatment of obesity. The mechanisms underlying the dramatic effects of surgery on
+      insulin sensitivity and β-cell function are poorly understood. Bariatric surgery (gastric
+      bypass) promotes changes in the enteroendocrine system as a result of nutrient diversion
+      from the physiological intestinal routes with subsequent profound modification of gut
+      hormone secretion
+
+      We hypothesize that restoration of GIP action after bariatric procedures plays a cardinal
+      role in the improvement and/or restoration of diabetes, we propose to study patients (both
+      sex)with morbid obesity and T2DM within 3 months after their surgery. Their responses will
+      be compared to those of BMI matched control subjects with normal glucose tolerance
+    </textblock>
+  </brief_summary>
+  <overall_status>Recruiting</overall_status>
+  <start_date>April 2011</start_date>
+  <completion_date type="Anticipated">December 2012</completion_date>
+  <primary_completion_date type="Anticipated">December 2012</primary_completion_date>
+  <phase>N/A</phase>
+  <study_type>Interventional</study_type>
+  <study_design>Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science</study_design>
+  <primary_outcome>
+    <measure>To measure Lipoprotein lipase (LPL) and Hormone sensitive Lipase (HSL) activity in adipose tissue</measure>
+    <time_frame>Before and after 4 hours of infusion</time_frame>
+    <safety_issue>No</safety_issue>
+  </primary_outcome>
+  <secondary_outcome>
+    <measure>To determine the role of GIP in adipocytokine gene expression and secretion from human subcutaneous adipose tissue</measure>
+    <time_frame>Baseline and after 4 hours of continuous infusion</time_frame>
+    <safety_issue>No</safety_issue>
+  </secondary_outcome>
+  <number_of_arms>1</number_of_arms>
+  <enrollment type="Anticipated">12</enrollment>
+  <condition>Adipose Tissue</condition>
+  <intervention>
+    <intervention_type>Other</intervention_type>
+    <intervention_name>GIP (glucose dependent insulinotropic peptide) infusion</intervention_name>
+    <description>an intravenous infusion of GIP (glucose dependent insulinotropic peptide)or placebo will be administered at a rate of 2 pmol/kg/min and maintained for 240 minutes.</description>
+    <other_name>GIP (glucose dependent insulinotropic peptide)</other_name>
+  </intervention>
+  <eligibility>
+    <criteria>
+      <textblock>
+        Inclusion Criteria:
+
+          -  Lean (BMI 20-25 kg/m2) subjects with normal glucose tolerance
+
+          -  Obese (BMI &gt;30 kg/m2) subjects also with normal glucose tolerance.
+
+          -  Obese with impaired glucose tolerance
+
+          -  Obese with diet controlled diabetes mellitus
+
+          -  Morbid obesity, type diabetes and post bariatric surgery (study part 2)
+
+        Exclusion Criteria:
+
+          -  History of severe cardiac, hepatic or renal disease
+
+          -  Thyroid dysfunction (hyper-or hypothyroidism), or other endocrine disturbance
+             (acromegaly, growth hormone deficiency, hypoadrenalism or cortisol overproduction)
+
+          -  Current malignant disease
+
+          -  Known alcohol misuse
+
+          -  Major psychiatric disease (including current use of antidepressants)
+
+          -  History of major eating disorder (anorexia or bulimia nervosa)
+      </textblock>
+    </criteria>
+    <gender>Male</gender>
+    <minimum_age>18 Years</minimum_age>
+    <maximum_age>75 Years</maximum_age>
+    <healthy_volunteers>No</healthy_volunteers>
+  </eligibility>
+  <overall_official>
+    <last_name>CHRISTINA DAOUSI, MD FRCP</last_name>
+    <role>Principal Investigator</role>
+    <affiliation>UNIVERSITY HOSPITAL AINTREE NHS TRUST</affiliation>
+  </overall_official>
+  <overall_contact>
+    <last_name>CHRISTINA DAOUSI, MD FRCP</last_name>
+    <phone>+44 (0) 151 529 5920</phone>
+    <email>cdaousi@liverpool.ac.uk</email>
+  </overall_contact>
+  <overall_contact_backup>
+    <last_name>Sravan K Thondam, MBBS MRCP</last_name>
+    <phone>+44 (0) 151 529 6464</phone>
+    <email>s.thondam@liverpool.ac.uk</email>
+  </overall_contact_backup>
+  <location>
+    <facility>
+      <name>University Hospital Aintree</name>
+      <address>
+        <city>Liverpool</city>
+        <zip>L9 7AL</zip>
+        <country>United Kingdom</country>
+      </address>
+    </facility>
+    <status>Recruiting</status>
+    <contact>
+      <last_name>Christina Daousi, MD FRCP</last_name>
+      <phone>+44 (0) 151 5295885</phone>
+      <email>cdaousi@liverpool.ac.uk</email>
+    </contact>
+    <contact_backup>
+      <last_name>Sravan K Thondam, MBBS MRCP</last_name>
+      <phone>44 (0) 151 5296464</phone>
+      <email>s.thondam@liverpool.ac.uk</email>
+    </contact_backup>
+    <investigator>
+      <last_name>Christina Daousi, MD FRCP</last_name>
+      <role>Principal Investigator</role>
+    </investigator>
+    <investigator>
+      <last_name>Sravan K Thondam, MBBS MRCP</last_name>
+      <role>Sub-Investigator</role>
+    </investigator>
+  </location>
+  <location_countries>
+    <country>United Kingdom</country>
+  </location_countries>
+  <verification_date>December 2011</verification_date>
+  <lastchanged_date>December 20, 2011</lastchanged_date>
+  <firstreceived_date>December 15, 2008</firstreceived_date>
+  <responsible_party>
+    <responsible_party_type>Principal Investigator</responsible_party_type>
+    <investigator_affiliation>Aintree University Hospitals NHS Foundation Trust</investigator_affiliation>
+    <investigator_full_name>DR CHRISTINA DAOUSI</investigator_full_name>
+    <investigator_title>Clinical Senior Lecturer</investigator_title>
+  </responsible_party>
+  <keyword>GIP</keyword>
+  <keyword>OBESITY</keyword>
+  <keyword>HSL</keyword>
+  <keyword>LPL</keyword>
+  <keyword>ADIPOCYTOKINES</keyword>
+  <keyword>BARIATRIC SURGERY</keyword>
+  <is_fda_regulated>No</is_fda_regulated>
+  <has_expanded_access>No</has_expanded_access>
+  <intervention_browse>
+    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm  -->
+    <mesh_term>Gastric Inhibitory Polypeptide</mesh_term>
+  </intervention_browse>
+  <!-- Results have not yet been posted for this study                                -->
+</clinical_study>