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KP-10 and Insulin Secretion in Men

NCT ID: NCT03771326

Last Updated: 2018-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-29

Study Completion Date

2014-01-10

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

All the individuals were told before the use of Kp-10 administration. however, to avoid psychological effect the exact time was not disclosed.

Study Groups

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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.

Group Type EXPERIMENTAL

Kisspeptin-10

Intervention Type BIOLOGICAL

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

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.

Group Type EXPERIMENTAL

Kisspeptin-10

Intervention Type BIOLOGICAL

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

Interventions

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Kisspeptin-10

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Normal BMI
* Normal renal function
* Normal liver function
* Normal blood count

Exclusion Criteria

* Disease history
* Diabetes
* Other trauma
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Quaid-e-Azam University

OTHER

Sponsor Role lead

Responsible Party

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Ghulam Nabi

Head of Animal Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type RESULT
PMID: 22192948 (View on PubMed)

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.

Reference Type RESULT
PMID: 21136344 (View on PubMed)

Other Identifiers

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Kisspeptin12

Identifier Type: -

Identifier Source: org_study_id