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Trial · Interventional

CompletedPhase 3Registry data

KP-10 and Insulin Secretion in Men

Overview

Status
Completed
Phase
Phase 3
Enrollment
14 participants (actual)
Sponsor
Quaid-e-Azam University · Other
Design
Randomized · Open label (no masking)
Countries
Not stated
Start
29 Oct 2013
Primary completion
4 Nov 2013
Completion
10 Jan 2014
First posted
11 Dec 2018
Last update posted
12 Dec 2018
Conditions
Kisspeptin Action on Insulin in Healthy Normal Men · Kisspeptin Action on Insulin in Obese Diabetic Men

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201320142015
  1. Ph 3

    KP-10 and Insulin Secretion in Men

    NCT03771326

    29 Oct 2013 to 10 Jan 2014

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Kisspeptin-10Biological

Arms2

  • Experimental

    obese men

    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.

  • Experimental

    Normal men

    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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. 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.

    Registry 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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

2 studies on this page

PubMed tag: none · 2012

4 results

GPR54 peptide agonists stimulate insulin secretion from murine, porcine and human islets.

Bowe et al. 2012Isletscited by 42

PMID 22192948DOI 10.4161/isl.18261PUB-22192948

Rights unknown4 results

PubMed tag: none · 2011

2 results

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).

Wahab et al. 2011Hormone and metabolic research = Hormon- und Stoffwechselforschung = Hormones et metabolismecited by 33

PMID 21136344DOI 10.1055/s-0030-1268458PUB-21136344

Full text at the publisher2 results

Eligibility

Who could join, as posted.

Sex
Male
Age
from 20 Years up to 45 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Normal BMI * Normal renal function * Normal liver function * Normal blood count Exclusion Criteria: * Disease history * Diabetes * Other trauma

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