KP-10 and Insulin Secretion in Men

Quaid-e-Azam University

Status and phase: Completed; Phase 3

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

Treatments: Biological: Kisspeptin-10

Study type: Interventional

Funder types: Other

Identifiers

NCT03771326

Kisspeptin12

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Disease history
• Diabetes
• Other trauma

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

obese men

Experimental group

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.

Treatment:

Biological: Kisspeptin-10

Normal men

Experimental group

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.

Treatment:

Biological: Kisspeptin-10