Trial Outcomes & Findings for Evaluation of Kisspeptin Glucose-Stimulated Insulin Secretion With Oral Glucose Tolerance Test (NCT NCT04958109)
NCT ID: NCT04958109
Last Updated: 2024-12-12
Results Overview
Change in Oral glucose Sensitivity Index between kisspeptin and placebo arms in oral glucose tolerance test
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
16 participants
Primary outcome timeframe
3 hours
Results posted on
2024-12-12
Participant Flow
Boston area. 16 participants consented and were screened for eligibility between 10/2021 and 10/2022
There was no wash out or run in period. 4 individuals were found to be ineligible by criteria.
Participant milestones
| Measure |
Kisspeptin, Then Placebo
Oral Glucose Tolerance Test (OGTT): Administration of a 75 gm oral glucose tolerance test
Kisspeptin: Intravenous administration of kisspeptin 112-121 x 16 hours, with administration of OGTT at hour 12 After at least 2 weeks and up to 6 months, then Placebo: Intravenous administration of Placebo 16 hours, with administration of OGTT at hour 12
|
Placebo, Then Kisspeptin
• Intravenous administration of placebo x 16 hours
Oral Glucose Tolerance Test (OGTT): Administration of a 75 gm oral glucose tolerance test
Placebo: Intravenous administration of Placebo 16 hours, with administration of OGTT at hour 12 After at least 2 weeks and up to 6 months, then Kisspeptin: Intravenous administration of kisspeptin 112-121 x 16 hours, with administration of OGTT at hour 12
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
7
|
|
Overall Study
COMPLETED
|
4
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Kisspeptin, Then Placebo
Oral Glucose Tolerance Test (OGTT): Administration of a 75 gm oral glucose tolerance test
Kisspeptin: Intravenous administration of kisspeptin 112-121 x 16 hours, with administration of OGTT at hour 12 After at least 2 weeks and up to 6 months, then Placebo: Intravenous administration of Placebo 16 hours, with administration of OGTT at hour 12
|
Placebo, Then Kisspeptin
• Intravenous administration of placebo x 16 hours
Oral Glucose Tolerance Test (OGTT): Administration of a 75 gm oral glucose tolerance test
Placebo: Intravenous administration of Placebo 16 hours, with administration of OGTT at hour 12 After at least 2 weeks and up to 6 months, then Kisspeptin: Intravenous administration of kisspeptin 112-121 x 16 hours, with administration of OGTT at hour 12
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
per Participant flow only 5 participants completed in each arm
Baseline characteristics by cohort
| Measure |
Kisspeptin
n=4 Participants
• 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
n=7 Participants
• 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
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
26 years
STANDARD_DEVIATION 6.8 • n=5 Participants
|
26 years
STANDARD_DEVIATION 6.8 • n=7 Participants
|
26 years
STANDARD_DEVIATION 6.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants • per Participant flow only 5 participants completed in each arm
|
0 Participants
n=7 Participants • per Participant flow only 5 participants completed in each arm
|
0 Participants
n=5 Participants • per Participant flow only 5 participants completed in each arm
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants • per Participant flow only 5 participants completed in each arm
|
7 Participants
n=7 Participants • per Participant flow only 5 participants completed in each arm
|
11 Participants
n=5 Participants • per Participant flow only 5 participants completed in each arm
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants • per Participant flow only 5 participants completed in each arm
|
0 Participants
n=7 Participants • per Participant flow only 5 participants completed in each arm
|
0 Participants
n=5 Participants • per Participant flow only 5 participants completed in each arm
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 hoursPopulation: Individuals who completed both studies were evaluated
Change in Oral glucose Sensitivity Index between kisspeptin and placebo arms in oral glucose tolerance test
Outcome measures
| Measure |
Kisspeptin
n=9 Participants
• 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
n=9 Participants
• 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
|
|---|---|---|
|
Oral Glucose Sensitivity Index (Kisspeptin-Placebo)
|
517 ml min-1m-2
Standard Deviation 70
|
521 ml min-1m-2
Standard Deviation 82
|
Adverse Events
Kisspeptin
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Kisspeptin
n=9 participants at risk
Oral Glucose Tolerance Test(OGTT): Administration of a 75 gm oral glucose tolerance test Kisspeptin: Intravenous administration of kisspeptin 112-121 x 16 hours, then at hour 12 OGTT
|
Placebo
n=9 participants at risk
Oral Glucose Tolerance Test (OGTT): Administration of a 75 gm oral glucose tolerance test Placebo: Intravenous administration of Placebo 16 hours, then at hour 12 OGTT
|
|---|---|---|
|
Reproductive system and breast disorders
Breast Pain
|
0.00%
0/9 • From time of study consent until study completion (approximately 5 months).
All participants were asked about new health symptoms at each visit.
|
11.1%
1/9 • Number of events 1 • From time of study consent until study completion (approximately 5 months).
All participants were asked about new health symptoms at each visit.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
44.4%
4/9 • Number of events 4 • From time of study consent until study completion (approximately 5 months).
All participants were asked about new health symptoms at each visit.
|
44.4%
4/9 • Number of events 4 • From time of study consent until study completion (approximately 5 months).
All participants were asked about new health symptoms at each visit.
|
|
Reproductive system and breast disorders
Dysmenorrhea
|
0.00%
0/9 • From time of study consent until study completion (approximately 5 months).
All participants were asked about new health symptoms at each visit.
|
11.1%
1/9 • Number of events 1 • From time of study consent until study completion (approximately 5 months).
All participants were asked about new health symptoms at each visit.
|
|
Reproductive system and breast disorders
Irregular Menstruation
|
22.2%
2/9 • Number of events 2 • From time of study consent until study completion (approximately 5 months).
All participants were asked about new health symptoms at each visit.
|
11.1%
1/9 • Number of events 1 • From time of study consent until study completion (approximately 5 months).
All participants were asked about new health symptoms at each visit.
|
|
Nervous system disorders
Headache
|
11.1%
1/9 • Number of events 1 • From time of study consent until study completion (approximately 5 months).
All participants were asked about new health symptoms at each visit.
|
11.1%
1/9 • Number of events 1 • From time of study consent until study completion (approximately 5 months).
All participants were asked about new health symptoms at each visit.
|
|
Infections and infestations
Infections and Infestations - Other, Specify
|
11.1%
1/9 • Number of events 1 • From time of study consent until study completion (approximately 5 months).
All participants were asked about new health symptoms at each visit.
|
22.2%
2/9 • Number of events 2 • From time of study consent until study completion (approximately 5 months).
All participants were asked about new health symptoms at each visit.
|
|
General disorders
Fatigue
|
11.1%
1/9 • Number of events 1 • From time of study consent until study completion (approximately 5 months).
All participants were asked about new health symptoms at each visit.
|
11.1%
1/9 • Number of events 1 • From time of study consent until study completion (approximately 5 months).
All participants were asked about new health symptoms at each visit.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/9 • From time of study consent until study completion (approximately 5 months).
All participants were asked about new health symptoms at each visit.
|
11.1%
1/9 • Number of events 1 • From time of study consent until study completion (approximately 5 months).
All participants were asked about new health symptoms at each visit.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place