Metabolic DiseasePhase 1NCT05456854
Evaluation of Kisspeptin Stimulated Insulin Secretion With Hyperglycemic Clamp
A Phase 1 study testing Hyperglycemic Clamp and Kisspeptin-10 in people with Metabolic Disease, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The goal of this study is to understand how exogenous kisspeptin affects metabolism by evaluating responses to an hyperglycemic clamp Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Metabolic Disease
- What is being tested?
- Hyperglycemic Clamp and Kisspeptin-10
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jun 2022to 1 Aug 2024
- Phase
- Phase 1
- 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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- active illicit drug use,
- history of a medication reaction requiring emergency medical care,
- difficulty with blood draws.
- history of hypertension, diabetes, heart disease, high cholesterol, cancer, or clotting disorders.
- history of chronic disease that has required hospitalization
- recent use of prescription medications which interfere with metabolism or reproduction (recent = within 5 half-lives of the drug) unless it is birth control
- history of diabetes in a first degree relative
- hyperlipidemia by fasting lipid panel
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
The goal of this study is to understand how exogenous kisspeptin affects metabolism by evaluating responses to an hyperglycemic clamp
Read the detailed description
Assignment: Each study subject will serve as their own control. The order of the visits will be randomized.
Delivery of Interventions:
Prior to the study visit, subjects will undergo a review of their medical history and screening laboratories.
During the inpatient study, the subjects will
Undergo a 16-hour kisspeptin infusion Undergo a hyperglycemic clamp
- Conditions
- Metabolic Disease
- Being tested
- Hyperglycemic Clamp, Kisspeptin-10, Placebo
- Medical subject headings
- Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperglycemic ClampDiagnostic test
Administration of a hyperglycemic clamp
Kisspeptin-10Drug
Administration of kisspeptin-10 * 16 hr
PlaceboDrug
Administration of placebo *16 hr
| Study group | Role | What they receive |
|---|---|---|
| Kisspeptin | Experimental | Intravenous administration of kisspeptin 112-121 x 16 hours Receives: Diagnostic Test: Hyperglycemic Clamp; Drug: Kisspeptin-10 |
| Placebo | Placebo comparator | Intravenous administration of placebo x 16 hours Receives: Diagnostic Test: Hyperglycemic Clamp; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
First Phase Insulin Secretion
Average Change in First Phase Insulin Secretion Between Kisspeptin and Placebo Arms
Measured: 10 minutes
Second Phase Insulin Secretion
Average Change in Second Phase Insulin Secretion Between Kisspeptin and Placebo Arms
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start3 Jun 2022
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Why it stopped: Futility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic DiseaseStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephanie B. Seminara, MD, Massachusetts General Hospital
- Investigators
- Margaret Lippincott, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05456854
- Sponsor's protocol ID
- 267335
- Status last verified
- Aug 2024
- First submitted
- 8 Jul 2022
- Last updated
- 14 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Kisspeptin Stimulated Insulin Secretion With Hyperglycemic Clamp
- ClinicalTrials.gov ID
- NCT05456854
- Acronym / sponsor ID
- 267335
- Conditions
- Metabolic Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Futility
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 3 Jun 2022 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 13 Jul 2022 (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.
The goal of this study is to understand how exogenous kisspeptin affects metabolism by evaluating responses to an hyperglycemic clamp
Detailed description
Assignment: Each study subject will serve as their own control. The order of the visits will be randomized.
Delivery of Interventions:
Prior to the study visit, subjects will undergo a review of their medical history and screening laboratories.
During the inpatient study, the subjects will
Undergo a 16-hour kisspeptin infusion Undergo a hyperglycemic clamp
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kisspeptin | Experimental | Diagnostic Test: Hyperglycemic Clamp, Drug: Kisspeptin-10Intravenous administration of kisspeptin 112-121 x 16 hours |
| Placebo | Placebo comparator | Diagnostic Test: Hyperglycemic Clamp, Drug: PlaceboIntravenous administration of placebo x 16 hours |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (8 listed)
- active illicit drug use,
- history of a medication reaction requiring emergency medical care,
- difficulty with blood draws.
- history of hypertension, diabetes, heart disease, high cholesterol, cancer, or clotting disorders.
- history of chronic disease that has required hospitalization
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 |
|---|---|---|
| Hyperglycemic ClampAdministration of a hyperglycemic clamp | Diagnostic test | Kisspeptin, Placebo |
| Kisspeptin-10Administration of kisspeptin-10 * 16 hr | Drug | Kisspeptin |
| PlaceboAdministration of placebo *16 hr | Drug | Placebo |
Primary outcome
First Phase Insulin Secretion
Time frame: 10 minutes
Average Change in First Phase Insulin Secretion Between Kisspeptin and Placebo Arms
Second Phase Insulin Secretion
Time frame: 2 hours
Average Change in Second Phase Insulin Secretion Between Kisspeptin and Placebo Arms
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2024.
- Individual participant dataSharing planned: No
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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.
Margaret Lippincott principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Hyperglycemic Clamp and Kisspeptin-10 in people with Metabolic Disease, run by Massachusetts General Hospital at 1 site in United States.
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 0 inclusion and 8 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: withdrawn, as of the sponsor's last update on 14 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was withdrawn before enrolling participants, so there are no results.
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?
First Phase Insulin Secretion (time frame: 10 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Aug 2024.