Clinical studies to examine the effect of kisspeptin in delayed puberty
| ISRCTN | ISRCTN44496480 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN44496480 |
| IRAS number | 238238 |
| Secondary identifying numbers | IRAS 238238, CPMS 37187 |
- Submission date
- 16/03/2023
- Registration date
- 27/03/2023
- Last edited
- 14/08/2023
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English Summary
Background and study aims
Puberty is the time when boys and girls mature into adults, and it usually starts between the ages of 8 and 14. The brain controls puberty, and a small number of children might not start puberty at the same time as most other children. This delay can be caused by a genetic disorder or simply by a normal variation in development. Doctors need to be able to tell the difference between these two groups of children so they can provide the appropriate treatment.
Scientists have found a hormone called 'kisspeptin' that plays an important role in regulating puberty. It works by telling the brain to produce reproductive hormones. Researchers want to study how children with delayed puberty respond to kisspeptin to see if it can help distinguish between those with normal development and those with a genetic disorder. By understanding how kisspeptin affects the body, doctors may be able to create better tests for diagnosing delayed puberty in the future.
Who can participate?
Children with delayed puberty.
What does the study involve?
Participants will attend at least two visits in 2 months, at least 1 week apart at The Children's Clinical Research Facility, St Mary's Hospital, London. At visit one GnRH will be administered intravenously and at the other kisspeptin will be administered. Blood samples will be collected through a cannula (tube) not more than every 15 minutes for up to 4 hours [Visit 1] and not more than every 10 minutes for up to 8 hours [Visit 2] to measure reproductive hormone release.
What are the possible benefits and risks of participating?
Kisspeptin is a naturally occurring hormone which has been given to over 300 men and women without complications or side effects. The main benefit will be to help develop a future diagnostic test/treatment for patients with delayed puberty.
Where is the study run from?
Imperial College London (UK)
When is the study starting and how long is it expected to run for?
December 2017 to November 2025
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
Dr Ali Abbara
imperial.kisspeptin@nhs.net
Contact information
Public
6th Floor Commonwealth Building
Imperial College London
Hammersmith Campus
Du Cane Road
London
W12 0NN
United Kingdom
 ORCID ID |
0000-0003-2795-5256 |
|---|---|
| Phone | +44 (0)207 594 3487 |
| imperial.kisspeptin@nhs.net |
Principal Investigator
6th Floor Commonwealth Building
Imperial College London
Hammersmith Campus
Du Cane Road
London
W12 0NN
United Kingdom
| ORCID ID |
0000-0001-5950-4316 |
|---|---|
| Phone | +44 (0)207 594 3487 |
| imperial.kisspeptin@nhs.net |
Study information
| Study design | Interventional non randomized |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | 43365 PIS for parent(s)_legal guardian(s) v3 31.07.2022.pdf |
| Scientific title | Investigating the physiological hormonal response to kisspeptin in delayed puberty |
| Study hypothesis | Children with delayed puberty due to congenital hypogonadotropic hypogonadism (CHH) will have reduced hypothalamic function and thus a minimal response to kisspeptin. By comparison, children with constitutional delay of growth and puberty (CDGP) should have normal hypothalamic function and should therefore respond to kisspeptin. |
| Ethics approval(s) | Approved 02/02/2018, London-West London & GTAC Research Ethics Committee (The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS, UK; +44 207104 8256; westlondon.rec@hra.nhs.uk), ref: 18/LO/0043 |
| Condition | Children with delayed puberty |
| Intervention | Assessment of hormonal response to kisspeptin and GnRH in delayed puberty. Visit 1: Following intravenous administration of GnRH (2.5mcg/kg, maximum dose 100mcg) serum reproductive hormones are measured not more than every 15 minutes for up to 4 hours. Visit 2: Following intravenous administration of kisspeptin-54 (6.4-12.8 nmol/kg) serum reproductive hormones are measured not more than every 10 minutes for up to 8 hours. Second visit will be performed within 2 months of the first visit. |
| Intervention type | Other |
| Primary outcome measure | Serum luteinising hormone (LH) measured using blood test at each visit not more than every 15 minutes for up to 4 hours. |
| Secondary outcome measures | 1. Serum reproductive hormones (e.g. follicle stimulating hormone [FSH]; testosterone in boys and oestradiol and progesterone in girls) measured using blood test not more than every 10 minutes for up to 8 hours. 2. Safety monitoring: heart rate, blood pressure (measured using automated blood pressure monitor every 15-30 minutes) and the presence of adverse symptoms. |
| Overall study start date | 18/12/2017 |
| Overall study end date | 01/11/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 13 Years |
| Sex | Both |
| Target number of participants | 80 children with delayed puberty |
| Participant inclusion criteria | Children with delayed puberty. Girls aged ≥ 13 years old, boys aged ≥ 14 years old. |
| Participant exclusion criteria | 1. The child is unable or unwilling to give assent 2. Children with untreated anaemia 3. Children with a medical condition that could affect the reproductive axis and prevent evaluation of hormonal response to kisspeptin 4. Children who are currently in a research study or have participated in research in the last three months |
| Recruitment start date | 04/08/2023 |
| Recruitment end date | 31/08/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
St Mary’s Hospital
Praed Street
London
W2 1NY
United Kingdom
Sponsor information
University/education
Hammersmith Campus
Du Cane Road
London
W12 0NN
England
United Kingdom
| Phone | +44 (0)20 7589 5111 |
|---|---|
| becky.ward@imperial.ac.uk | |
| Website | http://imperial.ac.uk |
"ROR" |
https://ror.org/041kmwe10 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/08/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | 1. Presentation at national and international scientific conferences 2. Publication in high-impact medical journals |
| IPD sharing plan | Restrictions apply to the availability of some or all data generated or analyzed during this study to preserve patient confidentiality. The team will on request detail the restrictions and any conditions under which access to some data may be provided. Please contact Prof. Waljit Dhillo (w.dhillo@imperial.ac.uk). The data will only become available once the study has been completed and will be at the discretion of the PI. Most data will not be available due to participant confidentiality. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | for parents/legal guardians version 3 |
31/07/2022 | 27/03/2023 | No | Yes |
| Participant information sheet | for young people with delayed puberty version 2 |
31/07/2022 | 27/03/2023 | No | Yes |
| HRA research summary | 28/06/2023 | No | No |
Additional files
- 43365 PIS for young people with delayed puberty v2 31.07.2022.pdf
- for young people with delayed puberty
- 43365 PIS for parent(s)_legal guardian(s) v3 31.07.2022.pdf
- for parents/legal guardians
Editorial Notes
14/08/2023: The recruitment start date was changed from 17/01/2020 to 04/08/2023.
03/04/2023: Internal review.
27/03/2023: Trial's existence confirmed by London-West London & GTAC Research Ethics Committee.
