Phase 1
N=11
Evaluation of Kisspeptin Glucose-Stimulated Insulin Secretion With Oral Glucose Tolerance Test
Metabolic Diseases
Bottom Line
View on ClinicalTrials.gov: NCT04958109 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcome: Primary: Oral Glucose Sensitivity Index (Kisspeptin-Placebo) — 517; 521 ml min-1m-2
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Oral Glucose Tolerance Test (Diagnostic_test); Kisspeptin (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Oct 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Oral Glucose Sensitivity Index (Kisspeptin-Placebo) |
517; 521 | — |
Summary
The goal of this study is to understand how exogenous kisspeptin affects metabolism by evaluating responses to an oral glucose tolerance test
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT04958109). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.