Preliminary Evidence Suggesting That Acute Administration of KP-10 Induces Insulin Secretion in Normal Weight But Not in Obese Men
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 14
- Primary Endpoint
- Changes in the response of insulin secretion to acute exogenous kisspeptin administration
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- None
Masking Description
All the individuals were told before the use of Kp-10 administration. however, to avoid psychological effect the exact time was not disclosed.
Eligibility Criteria
- Ages
- 20 Years to 45 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Normal BMI
- •Normal renal function
- •Normal liver function
- •Normal blood count
Exclusion Criteria
- •Disease history
- •Other trauma
Arms & Interventions
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.
Intervention: Kisspeptin-10 (Biological)
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.
Intervention: Kisspeptin-10 (Biological)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Ghulam Nabi
Head of Animal Sciences
Quaid-e-Azam University