KP-10 and Insulin Secretion in Men

NCT03771326 | Completed Phase 3

• 1 other identifier: Kisspeptin12
• Study Type: interventional
• Target: 14
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

Study Arms (2)

obese men

EXPERIMENTAL

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

Normal men

EXPERIMENTAL

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

Interventions

Kisspeptin-10 BIOLOGICAL

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

Normal men; obese men

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Disease history
• Diabetes
• Other trauma

Sponsors & Collaborators

• Quaid-e-Azam University: lead

Related Publications (2)

• 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 RESULT

• 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 RESULT

MeSH Terms

Interventions

KISS1 protein, human

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: All the individuals were told before the use of Kp-10 administration. however, to avoid psychological effect the exact time was not disclosed.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Animal Sciences

Model Details: 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

Study Record Dates

• First Submitted: December 4, 2018
• First Posted: December 11, 2018
• Study Start: October 29, 2013
• Primary Completion: November 4, 2013
• Study Completion: January 10, 2014
• Last Updated: December 12, 2018

Record last verified: 2018-12