Evaluation of Kisspeptin Stimulated Insulin Secretion With Hyperglycemic Clamp
NCT ID: NCT05456854
Last Updated: 2024-08-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1
INTERVENTIONAL
2022-06-03
2024-08-01
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 a hyperglycemic clamp
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
Hyperglycemic Clamp
Administration of a hyperglycemic clamp
Kisspeptin-10
Administration of kisspeptin-10 \* 16 hr
Placebo
Intravenous administration of placebo x 16 hours
Hyperglycemic Clamp
Administration of a hyperglycemic clamp
Placebo
Administration of placebo \*16 hr
Interventions
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Hyperglycemic Clamp
Administration of a hyperglycemic clamp
Kisspeptin-10
Administration of kisspeptin-10 \* 16 hr
Placebo
Administration of placebo \*16 hr
Eligibility Criteria
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Exclusion Criteria
* 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
18 Years
40 Years
FEMALE
Yes
Sponsors
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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
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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Other Identifiers
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267335
Identifier Type: -
Identifier Source: org_study_id
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