<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/NCT03771326</url>
  </required_header>
  <id_info>
    <org_study_id>Kisspeptin12</org_study_id>
    <nct_id>NCT03771326</nct_id>
  </id_info>
  <brief_title>KP-10 and Insulin Secretion in Men</brief_title>
  <official_title>Preliminary Evidence Suggesting That Acute Administration of KP-10 Induces Insulin Secretion in Normal Weight But Not in Obese Men</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Quaid-e-Azam University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Quaid-e-Azam University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Induction of insulin secretion by kisspeptin is observed in mouse, pig, rat, and human islets&#xD;
      in vitro and in rats, mice and monkeys in vivo, but its mechanism is not fully clear. The&#xD;
      present study was designed to investigate the role of KP-10 on insulin secretion in adult&#xD;
      healthy and obese men with insulin resistance. The aim of selection of obese persons for the&#xD;
      present study was to investigate the effect of acute KP-10 administration in a metabolically&#xD;
      challenged condition where the pancreatic beta cells are already highly activated. The&#xD;
      long-term objective of this study was to understand the physiological role of kisspeptin&#xD;
      signalling in the regulation of insulin secretion in human health and disease.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 29, 2013</start_date>
  <completion_date type="Actual">January 10, 2014</completion_date>
  <primary_completion_date type="Actual">November 4, 2013</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>
    <intervention_model_description>Fourteen volunteers (aged 20-45 years), including seven adult normal weight healthy men (mean body weight and BMI 75.5±4.8 kg and 23±0.7 kg/m2, respectively) and seven obese men (mean body weight and BMI 115±15 kg and 34±2 kg/m2, respectively), participated in this clinical study</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>All the individuals were told before the use of Kp-10 administration. however, to avoid psychological effect the exact time was not disclosed.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in the response of insulin secretion to acute exogenous kisspeptin administration</measure>
    <time_frame>Each participant was studied up to 4 hours. Blood samples from each individual was collected for 30 minutes pre and 120 minutes post KP-10 administration, at 30 minutes interval.</time_frame>
    <description>The blood samples were obtained and analysed for insulin by Enzyme Linked Immunosorbent Assay to know the differential response of insulin secretion to exogenous kisspeptin-10 administration in healthy and obese men.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>Kisspeptin Action on Insulin in Healthy Normal Men</condition>
  <condition>Kisspeptin Action on Insulin in Obese Diabetic Men</condition>
  <arm_group>
    <arm_group_label>obese men</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>To the 7 obese men, kisspeptin-10 was intravenously administered (0.5µg/kg BW, prepared under sterile conditions), as a bolus in a volume of 1ml. Blood samples from all the individuals were collected for 30 minutes pre and 120 minutes post-KP-10 administration, at 30 minutes interval. The obtained blood was centrifuged and the plasma insulin was measured by ELISA.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Normal men</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>To the 7 normal BMI mean, kisspeptin-10 was intravenously administered (0.5µg/kg BW, prepared under sterile conditions), as a bolus in a volume of 1ml. Blood samples from all the individuals were collected for 30 minutes pre and 120 minutes post-KP-10 administration, at 30 minutes interval. The obtained blood was centrifuged and the plasma insulin was measured by ELISA.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Kisspeptin-10</intervention_name>
    <description>Kisspeptin-10 (metastin 45-54, Calbiochem, Darmstadt, Germany)</description>
    <arm_group_label>Normal men</arm_group_label>
    <arm_group_label>obese men</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Normal BMI&#xD;
&#xD;
          -  Normal renal function&#xD;
&#xD;
          -  Normal liver function&#xD;
&#xD;
          -  Normal blood count&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Disease history&#xD;
&#xD;
          -  Diabetes&#xD;
&#xD;
          -  Other trauma&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <results_reference>
    <citation>Bowe JE, Foot VL, Amiel SA, Huang GC, Lamb MW, Lakey J, Jones PM, Persaud SJ. GPR54 peptide agonists stimulate insulin secretion from murine, porcine and human islets. Islets. 2012 Jan-Feb;4(1):20-3. doi: 10.4161/isl.18261. Epub 2011 Dec 23.</citation>
    <PMID>22192948</PMID>
  </results_reference>
  <results_reference>
    <citation>Wahab F, Riaz T, Shahab M. Study on the effect of peripheral kisspeptin administration on basal and glucose-induced insulin secretion under fed and fasting conditions in the adult male rhesus monkey (Macaca mulatta). Horm Metab Res. 2011 Jan;43(1):37-42. doi: 10.1055/s-0030-1268458. Epub 2010 Dec 6.</citation>
    <PMID>21136344</PMID>
  </results_reference>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 4, 2018</study_first_submitted>
  <study_first_submitted_qc>December 7, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 11, 2018</study_first_posted>
  <last_update_submitted>December 10, 2018</last_update_submitted>
  <last_update_submitted_qc>December 10, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 12, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Quaid-e-Azam University</investigator_affiliation>
    <investigator_full_name>Ghulam Nabi</investigator_full_name>
    <investigator_title>Head of Animal Sciences</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>This study is already completed. Investigators can disclose participants information after the article is available online.</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/NCT03771326
org study id: Kisspeptin12
nct id: NCT03771326
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Induction of insulin secretion by kisspeptin is observed in mouse, pig, rat, and human islets
      in vitro and in rats, mice and monkeys in vivo, but its mechanism is not fully clear. The
      present study was designed to investigate the role of KP-10 on insulin secretion in adult
      healthy and obese men with insulin resistance. The aim of selection of obese persons for the
      present study was to investigate the effect of acute KP-10 administration in a metabolically
      challenged condition where the pancreatic beta cells are already highly activated. The
      long-term objective of this study was to understand the physiological role of kisspeptin
      signalling in the regulation of insulin secretion in human health and disease.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Fourteen volunteers (aged 20-45 years), including seven adult normal weight healthy men (mean body weight and BMI 75.5±4.8 kg and 23±0.7 kg/m2, respectively) and seven obese men (mean body weight and BMI 115±15 kg and 34±2 kg/m2, respectively), participated in this clinical study
primary purpose: Basic Science
masking: None (Open Label)
masking description: All the individuals were told before the use of Kp-10 administration. however, to avoid psychological effect the exact time was not disclosed.
measure: Changes in the response of insulin secretion to acute exogenous kisspeptin administration
time frame: Each participant was studied up to 4 hours. Blood samples from each individual was collected for 30 minutes pre and 120 minutes post KP-10 administration, at 30 minutes interval.
description: The blood samples were obtained and analysed for insulin by Enzyme Linked Immunosorbent Assay to know the differential response of insulin secretion to exogenous kisspeptin-10 administration in healthy and obese men.
arm group label: obese men
arm group type: Experimental
description: To the 7 obese men, kisspeptin-10 was intravenously administered (0.5µg/kg BW, prepared under sterile conditions), as a bolus in a volume of 1ml. Blood samples from all the individuals were collected for 30 minutes pre and 120 minutes post-KP-10 administration, at 30 minutes interval. The obtained blood was centrifuged and the plasma insulin was measured by ELISA.
arm group label: Normal men
arm group type: Experimental
description: To the 7 normal BMI mean, kisspeptin-10 was intravenously administered (0.5µg/kg BW, prepared under sterile conditions), as a bolus in a volume of 1ml. Blood samples from all the individuals were collected for 30 minutes pre and 120 minutes post-KP-10 administration, at 30 minutes interval. The obtained blood was centrifuged and the plasma insulin was measured by ELISA.
intervention type: Biological
intervention name: Kisspeptin-10
description: Kisspeptin-10 (metastin 45-54, Calbiochem, Darmstadt, Germany)
arm group label: Normal men
arm group label: obese men
criteria: 
gender: Male
minimum age: 20 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
citation: Bowe JE, Foot VL, Amiel SA, Huang GC, Lamb MW, Lakey J, Jones PM, Persaud SJ. GPR54 peptide agonists stimulate insulin secretion from murine, porcine and human islets. Islets. 2012 Jan-Feb;4(1):20-3. doi: 10.4161/isl.18261. Epub 2011 Dec 23.
PMID: 22192948
citation: Wahab F, Riaz T, Shahab M. Study on the effect of peripheral kisspeptin administration on basal and glucose-induced insulin secretion under fed and fasting conditions in the adult male rhesus monkey (Macaca mulatta). Horm Metab Res. 2011 Jan;43(1):37-42. doi: 10.1055/s-0030-1268458. Epub 2010 Dec 6.
PMID: 21136344
responsible party type: Principal Investigator
investigator affiliation: Quaid-e-Azam University
investigator full name: Ghulam Nabi
investigator title: Head of Animal Sciences
sharing ipd: Undecided
ipd description: This study is already completed. Investigators can disclose participants information after the article is available online.