InsulinPhase 1NCT04532801
Evaluation of Kisspeptin Glucose-Stimulated Insulin Secretion With Physiologic Mixed Meal Tolerance
A Phase 1 study testing Kisspeptin-10 and mixed meal tolerance test in people with Insulin and Glucose, run by Stephanie B. Seminara, MD at 1 site in United States.
Trial summary
This study utilizes infusions of kisspeptin in healthy women to isolate the impact of kisspeptin on beta-cell responsivity assessed by the mixed meal tolerance test. 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
- Insulin, Glucose, Healthy Volunteers
- What is being tested?
- Kisspeptin-10 and mixed meal tolerance test
- 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
- 1 Sep 2019to 21 Dec 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
HISTORY
- no personal history of chronic disease, except well controlled thyroid disease
- no history of diabetes in a first degree relative, including gestational diabetes
- no family or personal history of hyperlipidemia
- normal timing of menarche (age 10-14)
- normal menstrual cycles (q25-35 days)
- no use of contraceptive pills, patches or vaginal rings within last 4 weeks
- nulliparous (no history of a pregnancy)
- no active illicit drug use
- no history of a medication reaction requiring emergency medical care
- no difficulty with blood draws
- stable weight for previous three months
- available for all parts of the study
PHYSICAL
- body mass index (18.5-25)
- systolic BP < 120mm Hg, diastolic < 80 mm Hg
- normal waist circumference (less than 32 inches)
LABORATORY STUDIES: (per Massachusetts General Hospital reference ranges)
- fasting LDL cholesterol less than 130 mg/dL
- fasting triglycerides less than 150 mg/dL
- normal hemoglobin
- hemoglobin A1C < 5.7%
- blood urea nitrogen, creatinine not elevated
- AST, ALT not elevated
- negative serum pregnancy test
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
This study utilizes infusions of kisspeptin in healthy women to isolate the impact of kisspeptin on beta-cell responsivity assessed by the mixed meal tolerance test.
Read the detailed description
Assignment: each study subject serves as their own control, and will come in timed to their cycle. The order in which they undergo the kisspeptin or placebo arms is randomized and separated by greater than two weeks to minimize variability and study-specific effects.
Delivery of Interventions:
Prior to each visit, study subjects will be asked to:
- eat at least 150 gm carbohydrates per day
- refrain from strenuous exercise
On the day of the visit, study subjects will:
- eat a standardized meal prepared by the metabolic kitchen in the clinical research center
- be observed overnight to ensure a 12-hour fast
- have an IV placed, for a 16 hour kisspeptin or placebo infusion
- after the 12 hour fast, starting at 8 am in the morning will undergo a mixed meal tolerance test
- Conditions
- Insulin, Glucose, Healthy Volunteers, Women, Pregnancy
- Being tested
- Kisspeptin-10, mixed meal tolerance test
- Keywords
- kisspeptin, follicular phase
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kisspeptin-10Drug
Also called kisspeptin
kisspeptin-10 IV infusion
mixed meal tolerance testOther
mixed meal tolerance test
| Study group | Role | What they receive |
|---|---|---|
| kisspeptin-10 | Experimental | kisspeptin infusion Receives: Drug: Kisspeptin-10; Other: mixed meal tolerance test |
| placebo | Placebo comparator | placebo Receives: Other: mixed meal tolerance test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beta-cell responsivity index
Average beta-cell responsivity index derived from mixed meal tolerance data comparing placebo and kisspeptin arms
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2020
- Study start1 Sep 2019
- Primary completion31 Aug 2024 (estimated)
- Study completion21 Dec 2024 (estimated)
Why it stopped: Interim analysis of data collected under other clinical trials demonstrated planned enrollment was insufficiently powered.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsulinStudies 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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- physiologic studies
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stephanie B. Seminara, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Stephanie B. Seminara, MD, Massachusetts General Hospital
- Investigators
- Margaret Lippincott, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04532801
- Sponsor's protocol ID
- 267337
- Status last verified
- Jul 2024
- First submitted
- 23 Aug 2020
- Last updated
- 1 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 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Kisspeptin Glucose-Stimulated Insulin Secretion With Physiologic Mixed Meal Tolerance
- ClinicalTrials.gov ID
- NCT04532801
- Acronym / sponsor ID
- 267337
- Conditions
- Insulin, Glucose, Healthy Volunteers, Women, Pregnancy
- Keywords
- kisspeptin, follicular phase
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Interim analysis of data collected under other clinical trials demonstrated planned enrollment was insufficiently powered.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stephanie B. Seminara, MDUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 21 Dec 2024 (estimated)
- First posted
- 31 Aug 2020 (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.
This study utilizes infusions of kisspeptin in healthy women to isolate the impact of kisspeptin on beta-cell responsivity assessed by the mixed meal tolerance test.
Detailed description
Assignment: each study subject serves as their own control, and will come in timed to their cycle. The order in which they undergo the kisspeptin or placebo arms is randomized and separated by greater than two weeks to minimize variability and study-specific effects.
Delivery of Interventions:
Prior to each visit, study subjects will be asked to:
- eat at least 150 gm carbohydrates per day
- refrain from strenuous exercise
On the day of the visit, study subjects will:
- eat a standardized meal prepared by the metabolic kitchen in the clinical research center
- be observed overnight to ensure a 12-hour fast
- have an IV placed, for a 16 hour kisspeptin or placebo infusion
- after the 12 hour fast, starting at 8 am in the morning will undergo a mixed meal tolerance test
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- physiologic studies
| Arm | Type | Receives |
|---|---|---|
| kisspeptin-10 | Experimental | Drug: Kisspeptin-10, Other: mixed meal tolerance testkisspeptin infusion |
| placebo | Placebo comparator | Other: mixed meal tolerance testplacebo |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
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-10Also: kisspeptinkisspeptin-10 IV infusion | Drug | kisspeptin-10 |
| mixed meal tolerance testmixed meal tolerance test | Other | kisspeptin-10, placebo |
Primary outcome
Beta-cell responsivity index
Time frame: up to 6 months
Average beta-cell responsivity index derived from mixed meal tolerance data comparing placebo and kisspeptin 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 1 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for Insulin
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Not yet recruitingPhase 2
Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity
Insulin Resistance, Obesity
Recruiting
Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial
Healthy Volunteer
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, MD 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 Kisspeptin-10 and mixed meal tolerance test in people with Insulin and Glucose, run by Stephanie B. Seminara, MD 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?
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 1 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?
Beta-cell responsivity index (time frame: up to 6 months). 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 1 Aug 2024.