Metabolic Diseases
Conditions
Brief summary
The goal of this study is to understand how exogenous kisspeptin affects metabolism by evaluating responses to an oral glucose tolerance test
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 an oral glucose tolerance test
Interventions
DIAGNOSTIC_TESTOral Glucose Tolerance Test
Administration of a 75 gm oral glucose tolerance test
DRUGKisspeptin
Intravenous administration of kisspeptin 112-121 x 16 hours
DRUGPlacebo
Intravenous administration of Placebo 16 hours
Sponsors
Massachusetts General Hospital
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
History: * over the age of 18, * normal pubertal development * stable weight for previous three months, * normal body mass index (BMI between 18.5-25) * regular menstrual cycles Physical examination: • systolic BP \< 140 mm Hg, diastolic \< 90 mm Hg Laboratory studies: (per Massachusetts General Hospital reference ranges) * normal hemoglobin * hemoglobin A1C \< 6.5% * blood urea nitrogen, creatinine not elevated * aspartate aminotransferase, alanine aminotransferase \< 3x upper limit of normal
Exclusion criteria
* active illicit drug use, * history of a medication reaction requiring emergency medical care, * difficulty with blood draws. * history of chronic disease, except well controlled thyroid disease, * recent use of prescription medications which interfere with metabolism or reproduction (recent = within 5 half-lives of the drug). Use of levothyroxine or seasonal allergy medications is acceptable, * history of diabetes in a first degree relative, * use of contraceptive pills, patches or vaginal rings within last 4 weeks. * hyperlipidemia by fasting lipid panel * positive serum pregnancy test (for all women)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oral Glucose Sensitivity Index (Kisspeptin-Placebo) | 3 hours | Change in Oral glucose Sensitivity Index between kisspeptin and placebo arms in oral glucose tolerance test |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMargaret Lippincott, MD
Massachusetts General Hospital
Participant flow
Recruitment details
Boston area. 16 participants consented and were screened for eligibility between 10/2021 and 10/2022
Pre-assignment details
There was no wash out or run in period. 4 individuals were found to be ineligible by criteria.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 4 |
| Placebo • 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 | 7 |
| Total | 11 |
Baseline characteristics
| Characteristic | Kisspeptin | Total | Placebo |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 11 Participants | 7 Participants |
| Age, Continuous | 26 years STANDARD_DEVIATION 6.8 | 26 years STANDARD_DEVIATION 6.8 | 26 years STANDARD_DEVIATION 6.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 11 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 9 Participants | 6 Participants |
| Region of Enrollment United States | 4 Participants | 11 Participants | 7 Participants |
| Sex: Female, Male Female | 4 Participants | 11 Participants | 7 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 9 |
| other Total, other adverse events | 6 / 9 | 6 / 9 |
| serious Total, serious adverse events | 0 / 9 | 0 / 9 |
Outcome results
Primary
Oral Glucose Sensitivity Index (Kisspeptin-Placebo)
Change in Oral glucose Sensitivity Index between kisspeptin and placebo arms in oral glucose tolerance test
Time frame: 3 hours
Population: Individuals who completed both studies were evaluated
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Kisspeptin | Oral Glucose Sensitivity Index (Kisspeptin-Placebo) | 517 ml min-1m-2 | Standard Deviation 70 |
| Placebo | Oral Glucose Sensitivity Index (Kisspeptin-Placebo) | 521 ml min-1m-2 | Standard Deviation 82 |