Evaluation of Kisspeptin Glucose-Stimulated Insulin Secretion With Oral Glucose Tolerance Test (NCT04958109) | Clinical Trial Compass
CompletedPhase 1
Evaluation of Kisspeptin Glucose-Stimulated Insulin Secretion With Oral Glucose Tolerance Test
United States16 participantsStarted 2021-10-28
Plain-language summary
The goal of this study is to understand how exogenous kisspeptin affects metabolism by evaluating responses to an oral glucose tolerance test
Who can participate
Age range18 Years ā 40 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
What they're measuring
1
Oral Glucose Sensitivity Index (Kisspeptin-Placebo)