<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/NCT01680133</url>
  </required_header>
  <id_info>
    <org_study_id>07-3-037</org_study_id>
    <secondary_id>91611074</secondary_id>
    <nct_id>NCT01680133</nct_id>
  </id_info>
  <brief_title>Regulation of Tissue Lipolysis by Insulin in Type 2 Diabetes</brief_title>
  <official_title>Regulation of Lipolysis by Insulin in Skeletal Muscle and Adipose Tissue in Type 2 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Maastricht University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Netherlands Organisation for Scientific Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>European Foundation for the Study of Diabetes</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Maastricht University Medical Center</source>
  <brief_summary>
    <textblock>
      Inadequate suppression of intramuscular and adipose tissue lipolysis, and consequent&#xD;
      excessive delivery of fatty acids to ectopic tissues (e.g. muscle, pancreas and liver) could&#xD;
      play an important role in the development and exacerbating of insulin resistance. Therefore,&#xD;
      the investigators propose to study the regulation of adipose tissue and skeletal muscle&#xD;
      lipolysis, as well as further characterize the intracellular lipolytic pathways within these&#xD;
      tissues, in obese normoglycaemic versus long-term diagnosed type 2 diabetic subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2007</start_date>
  <completion_date type="Actual">September 2011</completion_date>
  <primary_completion_date type="Actual">September 2011</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in insulin sensitivity of adipose tissue and skeletal muscle lipolysis</measure>
    <time_frame>8, 20 and 40 mU insulin (2 hours)</time_frame>
    <description>Changes from baseline in glycerol (lactate, pyruvate and glucose) in tissue microdialysate during a 3 step euglycemic hyperinsulinemic clamp (8, 20 and 40mU of insulin), every step for 2h</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Baseline adipose tissue and skeletal muscle gene expression</measure>
    <time_frame>baseline</time_frame>
    <description>gene expression of genes related to lipid, glucose metabolism, insulin signalling will be measured in baseline adipose tissue and skeletal muscle biopsies</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Baseline skeletal muscle lipid accumulation</measure>
    <time_frame>Baseline</time_frame>
    <description>Baseline skeletal muscle lipid accumulation is measured (TAG, DAG, Phospholipid and fatty acids)</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">20</enrollment>
  <condition>Type 2 Diabetes</condition>
  <arm_group>
    <arm_group_label>NGT</arm_group_label>
    <description>Normal glycaemic healthy control men, age between 45-65, BMI 25-35 kg/m2</description>
  </arm_group>
  <arm_group>
    <arm_group_label>T2D</arm_group_label>
    <description>Type 2 diabetic men, age 45-65 yrs, BMI 25-35, diagnosed &gt;5yrs and Hba1c 7-9%</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Hyperinsulinemic euglycemic clamp</intervention_name>
    <arm_group_label>NGT</arm_group_label>
    <arm_group_label>T2D</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      adipose tissue and skeletal muscle biopsies&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy normoglycemic men and type 2 diabetic men&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Caucasian&#xD;
&#xD;
          -  Normal blood pressure (SBP 100-140 mmHg, DBP 60-90 mmHg)&#xD;
&#xD;
          -  weight stable in last 3 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Smokers&#xD;
&#xD;
          -  people with intensive fitness training (e.g. athletes &gt; 3 times/week)&#xD;
&#xD;
          -  History of cardiovascular diseases&#xD;
&#xD;
          -  Bleeding disorders&#xD;
&#xD;
          -  Use of medication interfering with the study endpoints/hypotheses (e.g. beta-blockers)&#xD;
&#xD;
          -  Not to be able to understand the study information&#xD;
&#xD;
          -  Subjects on a special diet or vegetarian&#xD;
&#xD;
          -  Blood donation 2 months prior to the study and during the study&#xD;
&#xD;
          -  Participating in an other study&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ellen Blaak, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Maastricht University Medical centre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Human Biology, Maastricht University Medical Centre</name>
      <address>
        <city>Maastricht</city>
        <zip>6200MD</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <reference>
    <citation>Jocken JW, Moro C, Goossens GH, Hansen D, Mairal A, Hesselink MK, Langin D, van Loon LJ, Blaak EE. Skeletal muscle lipase content and activity in obesity and type 2 diabetes. J Clin Endocrinol Metab. 2010 Dec;95(12):5449-53. doi: 10.1210/jc.2010-0776. Epub 2010 Sep 15.</citation>
    <PMID>20843949</PMID>
  </reference>
  <reference>
    <citation>Jocken JW, Roepstorff C, Goossens GH, van der Baan P, van Baak M, Saris WH, Kiens B, Blaak EE. Hormone-sensitive lipase serine phosphorylation and glycerol exchange across skeletal muscle in lean and obese subjects: effect of beta-adrenergic stimulation. Diabetes. 2008 Jul;57(7):1834-41. doi: 10.2337/db07-0857. Epub 2008 Apr 8.</citation>
    <PMID>18398140</PMID>
  </reference>
  <reference>
    <citation>Jocken JW, Goossens GH, van Hees AM, Frayn KN, van Baak M, Stegen J, Pakbiers MT, Saris WH, Blaak EE. Effect of beta-adrenergic stimulation on whole-body and abdominal subcutaneous adipose tissue lipolysis in lean and obese men. Diabetologia. 2008 Feb;51(2):320-7. doi: 10.1007/s00125-007-0866-y. Epub 2007 Dec 5.</citation>
    <PMID>18060661</PMID>
  </reference>
  <reference>
    <citation>Boon H, Blaak EE, Saris WH, Keizer HA, Wagenmakers AJ, van Loon LJ. Substrate source utilisation in long-term diagnosed type 2 diabetes patients at rest, and during exercise and subsequent recovery. Diabetologia. 2007 Jan;50(1):103-12. doi: 10.1007/s00125-006-0482-2. Epub 2006 Nov 28.</citation>
    <PMID>17131144</PMID>
  </reference>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>August 21, 2012</study_first_submitted>
  <study_first_submitted_qc>September 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 7, 2012</study_first_posted>
  <last_update_submitted>October 11, 2012</last_update_submitted>
  <last_update_submitted_qc>October 11, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 12, 2012</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>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</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/NCT01680133
org study id: 07-3-037
secondary id: 91611074
nct id: NCT01680133
lead sponsor: 
collaborator: 
collaborator: 
Inadequate suppression of intramuscular and adipose tissue lipolysis, and consequent
      excessive delivery of fatty acids to ectopic tissues (e.g. muscle, pancreas and liver) could
      play an important role in the development and exacerbating of insulin resistance. Therefore,
      the investigators propose to study the regulation of adipose tissue and skeletal muscle
      lipolysis, as well as further characterize the intracellular lipolytic pathways within these
      tissues, in obese normoglycaemic versus long-term diagnosed type 2 diabetic subjects.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Change from baseline in insulin sensitivity of adipose tissue and skeletal muscle lipolysis
time frame: 8, 20 and 40 mU insulin (2 hours)
description: Changes from baseline in glycerol (lactate, pyruvate and glucose) in tissue microdialysate during a 3 step euglycemic hyperinsulinemic clamp (8, 20 and 40mU of insulin), every step for 2h
measure: Baseline adipose tissue and skeletal muscle gene expression
time frame: baseline
description: gene expression of genes related to lipid, glucose metabolism, insulin signalling will be measured in baseline adipose tissue and skeletal muscle biopsies
measure: Baseline skeletal muscle lipid accumulation
time frame: Baseline
description: Baseline skeletal muscle lipid accumulation is measured (TAG, DAG, Phospholipid and fatty acids)
arm group label: NGT
description: Normal glycaemic healthy control men, age between 45-65, BMI 25-35 kg/m2
arm group label: T2D
description: Type 2 diabetic men, age 45-65 yrs, BMI 25-35, diagnosed >5yrs and Hba1c 7-9%
intervention type: Other
intervention name: Hyperinsulinemic euglycemic clamp
arm group label: NGT
arm group label: T2D
adipose tissue and skeletal muscle biopsies
study pop: 
sampling method: Probability Sample
criteria: 
gender: Male
minimum age: 45 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ellen Blaak, PhD
role: Principal Investigator
affiliation: Maastricht University Medical centre
facility: 
country: Netherlands
citation: Jocken JW, Moro C, Goossens GH, Hansen D, Mairal A, Hesselink MK, Langin D, van Loon LJ, Blaak EE. Skeletal muscle lipase content and activity in obesity and type 2 diabetes. J Clin Endocrinol Metab. 2010 Dec;95(12):5449-53. doi: 10.1210/jc.2010-0776. Epub 2010 Sep 15.
PMID: 20843949
citation: Jocken JW, Roepstorff C, Goossens GH, van der Baan P, van Baak M, Saris WH, Kiens B, Blaak EE. Hormone-sensitive lipase serine phosphorylation and glycerol exchange across skeletal muscle in lean and obese subjects: effect of beta-adrenergic stimulation. Diabetes. 2008 Jul;57(7):1834-41. doi: 10.2337/db07-0857. Epub 2008 Apr 8.
PMID: 18398140
citation: Jocken JW, Goossens GH, van Hees AM, Frayn KN, van Baak M, Stegen J, Pakbiers MT, Saris WH, Blaak EE. Effect of beta-adrenergic stimulation on whole-body and abdominal subcutaneous adipose tissue lipolysis in lean and obese men. Diabetologia. 2008 Feb;51(2):320-7. doi: 10.1007/s00125-007-0866-y. Epub 2007 Dec 5.
PMID: 18060661
citation: Boon H, Blaak EE, Saris WH, Keizer HA, Wagenmakers AJ, van Loon LJ. Substrate source utilisation in long-term diagnosed type 2 diabetes patients at rest, and during exercise and subsequent recovery. Diabetologia. 2007 Jan;50(1):103-12. doi: 10.1007/s00125-006-0482-2. Epub 2006 Nov 28.
PMID: 17131144
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2