Evaluation of Kisspeptin Glucose-Stimulated Insulin Secretion With Oral Glucose Tolerance Test
NCT ID: NCT04958109
Last Updated: 2024-12-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
16 participants
INTERVENTIONAL
2021-10-28
2022-10-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
QUADRUPLE
Study Groups
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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
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
Interventions
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Oral Glucose Tolerance Test
Administration of a 75 gm oral glucose tolerance test
Kisspeptin
Intravenous administration of kisspeptin 112-121 x 16 hours
Placebo
Intravenous administration of Placebo 16 hours
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
40 Years
FEMALE
Yes
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Massachusetts General Hospital
OTHER
Responsible Party
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Stephanie B. Seminara, MD
Chief, Reproductive Endocrine Unit; Professor of Medicine, Harvard Medical School; Director, Harvard Reproductive Endocrine Sciences Center
Principal Investigators
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Margaret Lippincott, MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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267339
Identifier Type: -
Identifier Source: org_study_id
NCT02953834
Identifier Type: -
Identifier Source: nct_alias