Kisspeptin Influence on Glucose Homeostasis
Study Details
Study Description
Brief Summary
This study examines how a naturally occurring peptide called kisspeptin might regulate blood sugar and insulin levels.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Kisspeptin and Insulin Resistance Test intravenous administration of kisspeptin 112-121; eat a standard mixed meal or drink a standard mixed meal or 75 grams of oral glucose |
Drug: kisspeptin 112-121
Dose: 0.313-12.5 mcg/kg Duration: up to 16 hours
Other: Insulin Resistance Test
Eat or drink a standard meal OR drink a standard drink containing 75 grams of sugar
|
| Placebo Comparator: Placebo and Insulin Resistance Test intravenous administration of IV fluids that contain no study drug; eat a standard mixed meal or drink a standard mixed meal or 75 grams of oral glucose |
Other: Insulin Resistance Test
Eat or drink a standard meal OR drink a standard drink containing 75 grams of sugar
Other: Placebo
Receive intravenous fluids for up to 16 hours that do not contain any study drug
|
Outcome Measures
Primary Outcome Measures
- Average difference in area under the curve of insulin in response to a mixed meal tolerance test [4 hours]
Compares difference on and off kisspeptin
Secondary Outcome Measures
- Average difference in area under the curve of glucose in response to a mixed meal tolerance test [4 hours]
Compares difference on and off kisspeptin
- Average difference in area under the curve of glucagon-like peptide 1 in response to a mixed meal tolerance test [4 hours]
Compares difference on and off kisspeptin
Eligibility Criteria
Criteria
Inclusion/Exclusion Criteria:
History:
-
normal pubertal development
-
stable weight for previous three months
-
no active illicit drug use,
-
no history of a medication reaction requiring emergency medical care,
-
no difficulty with blood draws.
Physical examination:
• systolic BP < 140 mm Hg, diastolic < 90 mm Hg,
Laboratory studies: (per MGH reference ranges)
-
normal hemoglobin, unless hypogonadal then no lower than 0.5 gm/dL below the lower limit of the reference range for normal women (as men and women with hypogonadism have lower hemoglobin levels off of treatment)
-
hemoglobin A1C < 6.5%
-
BUN, creatinine not elevated
-
AST, ALT < 3x upper limit of normal
-
negative serum pregnancy test (for all women)
-
no hyperlipidemia by fasting lipid panel
Additional Criteria by Study Population
Healthy Men:
-
normal body mass index (BMI between 18.5-25)
-
no history of chronic disease, except well controlled thyroid disease
-
no recent use of prescription medications which interfere with metabolism or reproduction. Use of levothyroxine or seasonal allergy medications is acceptable.
-
no history of diabetes in a first degree relative.
Healthy Women:
-
normal body mass index (BMI between 18.5-25)
-
no history of chronic disease, except well controlled thyroid disease,
-
no recent use of prescription medications which interfere with metabolism or reproduction. Use of levothyroxine or seasonal allergy medications is acceptable.
-
no history of diabetes in a first degree relative,
-
no use of contraceptive pills, patches or vaginal rings within last 4 weeks.
-
regular menstrual cycles
Postmenopausal Women:
-
body mass index (BMI between 18.5-30)
-
no history of chronic disease except thyroid disease, and osteoporosis,
-
no recent use of prescription medications which interfere with metabolism or reproduction. Use of levothyroxine, osteoporosis medications or seasonal allergy medications is acceptable,
-
no history of diabetes in a first degree relative,
-
normal activate protein C resistance screen,
-
if applicable, able to undergo appropriate washout from hormone therapy.
Men and Women with Impaired Glucose Tolerance (IGT):
-
diagnosis of impaired glucose tolerance by oral glucose tolerance test,
-
all medical conditions well-controlled.
Men and Women with Hypogonadism
-
diagnosis of hypogonadism,
-
all other medical conditions well-controlled,
-
if applicable, able to undergo appropriate washout from hormone therapy.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02114 |
Sponsors and Collaborators
- Stephanie B. Seminara, MD
Investigators
- Principal Investigator: Margaret Lippincott, MD, Massachusetts General Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2016P001769