| ID | Type | Description | Link |
|---|---|---|---|
| 5K23HD097296 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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The goal of this study is to understand how exogenous kisspeptin affects metabolism by evaluating responses to an oral glucose tolerance test
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Kisspeptin | Experimental | • Intravenous administration of kisspeptin 112-121 x 16 hours |
|
| Placebo | Placebo Comparator | • Intravenous administration of placebo x 16 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral Glucose Tolerance Test | Diagnostic Test | Administration of a 75 gm oral glucose tolerance test |
|
| Measure | Description | Time Frame |
|---|---|---|
| Oral Glucose Sensitivity Index (Kisspeptin-Placebo) | Change in Oral glucose Sensitivity Index between kisspeptin and placebo arms in oral glucose tolerance test | 3 hours |
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Inclusion Criteria:
History:
Physical examination:
• systolic BP < 140 mm Hg, diastolic < 90 mm Hg
Laboratory studies: (per Massachusetts General Hospital reference ranges)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Margaret Lippincott, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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There was no wash out or run in period. 4 individuals were found to be ineligible by criteria.
Boston area. 16 participants consented and were screened for eligibility between 10/2021 and 10/2022
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| ID | Title | Description |
|---|---|---|
| FG000 | Kisspeptin, Then Placebo | Oral Glucose Tolerance Test (OGTT): Administration of a 75 gm oral glucose tolerance test Kisspeptin: Intravenous administration of kisspeptin 112-121 x 16 hours, with administration of OGTT at hour 12 After at least 2 weeks and up to 6 months, then Placebo: Intravenous administration of Placebo 16 hours, with administration of OGTT at hour 12 |
| FG001 | Placebo, Then Kisspeptin | • Intravenous administration of placebo x 16 hours Oral Glucose Tolerance Test (OGTT): Administration of a 75 gm oral glucose tolerance test Placebo: Intravenous administration of Placebo 16 hours, with administration of OGTT at hour 12 After at least 2 weeks and up to 6 months, then Kisspeptin: Intravenous administration of kisspeptin 112-121 x 16 hours, with administration of OGTT at hour 12 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Kisspeptin | • Intravenous administration of kisspeptin 112-121 x 16 hours Oral Glucose Tolerance Test: Administration of a 75 gm oral glucose tolerance test Kisspeptin: Intravenous administration of kisspeptin 112-121 x 16 hours |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Oral Glucose Sensitivity Index (Kisspeptin-Placebo) | Change in Oral glucose Sensitivity Index between kisspeptin and placebo arms in oral glucose tolerance test | Individuals who completed both studies were evaluated | Posted | Mean | Standard Deviation | ml min-1m-2 | 3 hours |
|
From time of study consent until study completion (approximately 5 months).
All participants were asked about new health symptoms at each visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Kisspeptin | Oral Glucose Tolerance Test(OGTT): Administration of a 75 gm oral glucose tolerance test Kisspeptin: Intravenous administration of kisspeptin 112-121 x 16 hours, then at hour 12 OGTT |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Breast Pain | Reproductive system and breast disorders | CTCAE (5.0) | Systematic Assessment | Subject reported typical breast pain associated with menstruation, while menstruating |
This was designed as a pilot study
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Margaret Lippincott | Massachusetts General Hospital | 6177268434 | mlippincott@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 11, 2024 | Oct 2, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 18, 2022 | Feb 10, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D008659 | Metabolic Diseases |
| ID | Term |
|---|---|
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D005951 | Glucose Tolerance Test |
| D059648 | Kisspeptins |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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| Kisspeptin | Drug | Intravenous administration of kisspeptin 112-121 x 16 hours |
|
| Placebo | Drug | Intravenous administration of Placebo 16 hours |
|
• Intravenous administration of placebo x 16 hours Oral Glucose Tolerance Test: Administration of a 75 gm oral glucose tolerance test Placebo: Intravenous administration of Placebo 16 hours |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | per Participant flow only 5 participants completed in each arm | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| 6 |
| 9 |
| EG001 | Placebo | Oral Glucose Tolerance Test (OGTT): Administration of a 75 gm oral glucose tolerance test Placebo: Intravenous administration of Placebo 16 hours, then at hour 12 OGTT | 0 | 9 | 0 | 9 | 6 | 9 |
|
| Skin and subcutaneous tissue disorders - Other, specify | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment | IV site reaction or bruise |
|
| Dysmenorrhea | Reproductive system and breast disorders | CTCAE (5.0) | Systematic Assessment | Subject reported menstrual cramps while menstruating |
|
| Irregular Menstruation | Reproductive system and breast disorders | CTCAE (5.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
|
| Infections and Infestations - Other, Specify | Infections and infestations | CTCAE (5.0) | Systematic Assessment | Coronavirus disease infection 2019 No subject had the Infection during active study protocol |
|
| Fatigue | General disorders | CTCAE (5.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
|
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| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008919 | Investigative Techniques |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009479 | Neuropeptides |
| D025521 | Tumor Suppressor Proteins |
| D009363 | Neoplasm Proteins |
| D011506 | Proteins |