Kisspeptin Action on Insulin in Healthy Normal MenPhase 3NCT03771326

KP-10 and Insulin Secretion in Men

A Phase 3 study testing Kisspeptin-10 in people with Kisspeptin Action on Insulin in Healthy Normal Men and Kisspeptin Action on Insulin in Obese Diabetic Men, run by Quaid-e-Azam University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 20 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for: Kisspeptin Action on Insulin in Healthy Normal Men, Kisspeptin Action on Insulin in Obese Diabetic Men
What is being tested?: Kisspeptin-10
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 14 participants
Where: No sites listed yet
Study dates: 29 Oct 2013to 10 Jan 2014
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 45 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Normal BMI
Normal renal function
Normal liver function
Normal blood count

Who cannot join

Disease history
Diabetes
Other trauma

About this study

Official title: Preliminary Evidence Suggesting That Acute Administration of KP-10 Induces Insulin Secretion in Normal Weight But Not in Obese 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.

Conditions: Kisspeptin Action on Insulin in Healthy Normal Men, Kisspeptin Action on Insulin in Obese Diabetic Men
Being tested: Kisspeptin-10

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT03771326
Study group	Role	What they receive
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. Receives: 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. Receives: Biological: Kisspeptin-10

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Oct 201310 Jan 2014

First posted11 Dec 2018
Study start29 Oct 2013
Primary completion4 Nov 2013
Study completion10 Jan 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Kisspeptin Action on Insulin in Healthy Normal MenStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Model description: 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
Masking: None (open label)
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03771326
Sponsor's protocol ID: Kisspeptin12
Status last verified: Dec 2018
First submitted: 4 Dec 2018
Last updated: 12 Dec 2018
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided: This study is already completed. Investigators can disclose participants information after the article is available online.

Publications

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.
PubMed 22192948
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.
PubMed 21136344

Study at a glance

From the registry record, last updated by the sponsor on 12 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Preliminary Evidence Suggesting That Acute Administration of KP-10 Induces Insulin Secretion in Normal Weight But Not in Obese Men
ClinicalTrials.gov ID: NCT03771326
Acronym / sponsor ID: Kisspeptin12
Conditions: Kisspeptin Action on Insulin in Healthy Normal Men, Kisspeptin Action on Insulin in Obese Diabetic Men
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 14 participants (actual)
Lead sponsor: Quaid-e-Azam UniversityUniversity, hospital or other
Study start: 29 Oct 2013 (actual)
Primary completion: 4 Nov 2013 (actual)
Study completion: 10 Jan 2014 (actual)
First posted: 11 Dec 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: 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

Arm	Type	Receives
obese men	Experimental	Biological: Kisspeptin-10To 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.
Normal men	Experimental	Biological: Kisspeptin-10To 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.

Who may qualify

Ages: 20 to 45 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Normal BMI
Normal renal function
Normal liver function
Normal blood count

Key exclusion criteria (3 listed)

Disease history
Diabetes
Other trauma

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Kisspeptin-10Kisspeptin-10 (metastin 45-54, Calbiochem, Darmstadt, Germany)	Biological	Normal men, obese men

Primary outcome

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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2018.
Results publication: PubMed 22192948Bowe 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.
Results publication: PubMed 21136344Wahab 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.
Individual participant dataSharing planned: Undecided. This study is already completed. Investigators can disclose participants information after the article is available online.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Kisspeptin-10 in people with Kisspeptin Action on Insulin in Healthy Normal Men and Kisspeptin Action on Insulin in Obese Diabetic Men, run by Quaid-e-Azam University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03771326, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2018.