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OpenTrials
Completed

NCT Number: NCT03771326

KP-10 and Insulin Secretion in Men

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.

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Key information

Conditions

Kisspeptin Action on Insulin in Healthy Normal Men Kisspeptin Action on Insulin in Obese Diabetic Men

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Normal BMI
  • Normal renal function
  • Normal liver function
  • Normal blood count

Exclusion criteria

  • Disease history
  • Diabetes
  • Other trauma

Treatment and study plan

Kisspeptin-10

Biological

Kisspeptin-10 (metastin 45-54, Calbiochem, Darmstadt, Germany)

Primary outcomes

  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.

    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.

Sponsors and collaborators

Lead sponsor

Quaid-e-Azam University

Other

Registry information

Official study title

Preliminary Evidence Suggesting That Acute Administration of KP-10 Induces Insulin Secretion in Normal Weight But Not in Obese Men

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Dec 11, 2018
Registry last updated
Dec 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.