A Phase 3 interventional study of Kisspeptin-10 in Kisspeptin Action on Insulin in Healthy Normal Men and Kisspeptin Action on Insulin in Obese Diabetic Men, sponsored by Quaid-e-Azam University. Completed. Open to male participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-12-12.
Sponsored by Quaid-e-Azam University · Phase 3, Interventional, and Basic science
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.
Quaid-e-Azam University is the lead sponsor of 5 studies on the registry; none are open to participants now.
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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.
Biological: Kisspeptin-10
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.
Biological: Kisspeptin-10
Kisspeptin-10 (metastin 45-54, Calbiochem, Darmstadt, Germany)
Changes in the response of insulin secretion to acute exogenous kisspeptin administration
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.
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.
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Plan to share: Undecided — This study is already completed. Investigators can disclose participants information after the article is available online.
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Quaid-e-Azam University