<?xml version="1.0" encoding="UTF-8"?>
<clinical_study rank="139470">
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<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 >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>
