Trial Outcomes & Findings for The Effect of Dipeptidyl Peptidase 4 Inhibition on Growth Hormone Secretion in Women With Polycystic Ovarian Syndrome (NCT NCT02122380)
NCT ID: NCT02122380
Last Updated: 2020-05-08
Results Overview
Growth hormone levels were determined every 10 minutes from 8 PM until 8 AM during the inpatient visit on the last day of each treatment. A mean of the GH levels was calculated for each participant, and then the value from each participant was averaged across all participants.
COMPLETED
PHASE4
23 participants
At completion of 30 days of placebo treatment and at completion of 30 days of sitagliptin treatment; every 10 minutes from 8 PM until 8 AM.
2020-05-08
Participant Flow
55 patients were screened for eligibility at Vanderbilt University Medical Center.
23 out of 55 participants were randomized. Of those not randomized, 23 were did not meet inclusion criteria and 9 declined to participate.
Participant milestones
| Measure |
Sitagliptin Then Placebo
Participants first received sitagliptin 100 mg by mouth daily for 30 days. After a washout period of 8 weeks, then then received Placebo daily for 30 days
|
Placebo Then Sitagliptin
Participants first received Placebo daily for 30 days. After a washout period of 8 weeks, they then received Sitagliptin 100 mg daily for 30 days
|
|---|---|---|
|
First Intervention (30 Days)
STARTED
|
11
|
12
|
|
First Intervention (30 Days)
COMPLETED
|
10
|
11
|
|
First Intervention (30 Days)
NOT COMPLETED
|
1
|
1
|
|
Washout (8 Weeks)
STARTED
|
10
|
11
|
|
Washout (8 Weeks)
COMPLETED
|
9
|
9
|
|
Washout (8 Weeks)
NOT COMPLETED
|
1
|
2
|
|
Second Intervention (30 Days)
STARTED
|
9
|
9
|
|
Second Intervention (30 Days)
COMPLETED
|
9
|
7
|
|
Second Intervention (30 Days)
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Sitagliptin Then Placebo
Participants first received sitagliptin 100 mg by mouth daily for 30 days. After a washout period of 8 weeks, then then received Placebo daily for 30 days
|
Placebo Then Sitagliptin
Participants first received Placebo daily for 30 days. After a washout period of 8 weeks, they then received Sitagliptin 100 mg daily for 30 days
|
|---|---|---|
|
First Intervention (30 Days)
Adverse Event
|
1
|
0
|
|
First Intervention (30 Days)
Physician Decision
|
0
|
1
|
|
Washout (8 Weeks)
Lost to Follow-up
|
1
|
0
|
|
Washout (8 Weeks)
No Longer Met Inclusion Criteria
|
0
|
2
|
|
Second Intervention (30 Days)
2 did not complete all of inpatient day
|
0
|
2
|
Baseline Characteristics
The Effect of Dipeptidyl Peptidase 4 Inhibition on Growth Hormone Secretion in Women With Polycystic Ovarian Syndrome
Baseline characteristics by cohort
| Measure |
Sitagliptin Then Placebo
n=11 Participants
Participants first received sitagliptin 100 mg by mouth daily for 30 days. After an 8 week washout period, they then received Placebo daily for 30 days.
|
Placebo Then Sitagliptin
n=12 Participants
Participants first received Placebo daily for 30 days. After an 8 week washout period, they then received Sitagliptin 100 mg daily for 30 days.
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
30.4 years
STANDARD_DEVIATION 4.3 • n=5 Participants
|
30.3 years
STANDARD_DEVIATION 4.3 • n=7 Participants
|
30.3 years
STANDARD_DEVIATION 4.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
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
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 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
|
PRIMARY outcome
Timeframe: At completion of 30 days of placebo treatment and at completion of 30 days of sitagliptin treatment; every 10 minutes from 8 PM until 8 AM.Population: All participants who received both interventions and completed both inpatient visits were included in the analysis. (1 participant was unable to complete their 2nd inpatient visit due to a family emergency. A 2nd participant was unable to complete the overnight portion of the inpatient visit due to illness in a family member.)
Growth hormone levels were determined every 10 minutes from 8 PM until 8 AM during the inpatient visit on the last day of each treatment. A mean of the GH levels was calculated for each participant, and then the value from each participant was averaged across all participants.
Outcome measures
| Measure |
Placebo
n=16 Participants
Participants who received Placebo tablet each morning in either the first 30 days or last 30 days of the study.
|
Sitagliptin
n=16 Participants
Participants who received Sitagliptin 100 mg daily each morning in either the first 30 days or last 30 days of the study.
|
|---|---|---|
|
Mean Overnight Growth Hormone Levels
|
0.85 ng/mL
Standard Deviation 0.54
|
0.84 ng/mL
Standard Deviation 0.51
|
SECONDARY outcome
Timeframe: During Outpatient Visit (after 2 weeks of therapy) during placebo and sitagliptin treatment periods. Insulin levels were obtained at time 0, 15 and 30 minutes following 75 gram glucose ingestion.Population: All participants who received both interventions and completed both outpatient study visits were included in the analysis.
Oral glucose tolerance testing was performed with 75 grams of glucose solution. Baseline venous blood samples of insulin were obtained prior to ingestion of oral glucose solution (time 0). Insulin levels were then obtained through a peripheral IV line every 15 minutes for 270 minutes after glucose solution is swallowed. Early insulin secretion was determined by calculating area under the curve using data (i.e. insulin levels) obtained at baseline (time 0), 15 minutes and 30 minutes.
Outcome measures
| Measure |
Placebo
n=18 Participants
Participants who received Placebo tablet each morning in either the first 30 days or last 30 days of the study.
|
Sitagliptin
n=18 Participants
Participants who received Sitagliptin 100 mg daily each morning in either the first 30 days or last 30 days of the study.
|
|---|---|---|
|
Early Insulin Secretion During Oral Glucose Tolerance Test
|
1522.1 microU*minutes/mL
Standard Deviation 792.3
|
1871.3 microU*minutes/mL
Standard Deviation 843.6
|
SECONDARY outcome
Timeframe: During Outpatient Visit (after 2 weeks of therapy) during placebo and sitagliptin treatment periods. Every 15 minutes from time 0 to 120 minutes after oral glucose ingestion.Population: All participants who received both interventions and completed both outpatient study visits were included in analysis.
Oral glucose tolerance testing was performed with 75 grams of glucose solution. Baseline blood glucose was obtained prior to ingestion of oral glucose solution (time 0). Blood glucose levels were then obtained through a peripheral IV line every 15 minutes from timepoint 0 until 120 minutes to calculate the area under the curve.
Outcome measures
| Measure |
Placebo
n=18 Participants
Participants who received Placebo tablet each morning in either the first 30 days or last 30 days of the study.
|
Sitagliptin
n=18 Participants
Participants who received Sitagliptin 100 mg daily each morning in either the first 30 days or last 30 days of the study.
|
|---|---|---|
|
Area Under the Curve (AUC) for Blood Glucoses During 75 Gram Oral Glucose Tolerance Test
|
15353.8 mg*minutes/dL
Standard Deviation 2708.6
|
13877.5 mg*minutes/dL
Standard Deviation 2486.3
|
SECONDARY outcome
Timeframe: At completion of 30 days of placebo treatment and at completion of 30 days of sitagliptin treatment.Population: All participants who received both interventions and completed all study protocols during the daytime portion of the inpatient visits were included in the analysis. (1 participant was unable to complete their 2nd inpatient visit due to a family emergency.)
During the inpatient visit of each treatment (placebo and sitagliptin), visceral adipose tissue was determined by a certified densitometrist using dual-energy x-ray absorptiometry with enCore software (v. 13.6)
Outcome measures
| Measure |
Placebo
n=17 Participants
Participants who received Placebo tablet each morning in either the first 30 days or last 30 days of the study.
|
Sitagliptin
n=17 Participants
Participants who received Sitagliptin 100 mg daily each morning in either the first 30 days or last 30 days of the study.
|
|---|---|---|
|
Visceral Adipose Tissue
|
1141.9 grams
Standard Deviation 700.7
|
1055.1 grams
Standard Deviation 710.1
|
SECONDARY outcome
Timeframe: Vascular function was determined by measuring brachial artery diameter at rest and during reactive hyperemia and calculating percent change. This was determined after 30 days of placebo treatment and after 30 days of sitagliptin treatment.Population: All participants who received both interventions and completed all study protocols during the daytime portion of the inpatient visits were included in the analysis. (1 participant was unable to complete their 2nd inpatient visit due to a family emergency.)
Endothelium-dependent vasodilation was evaluated by measuring the diameter of the brachial artery under basal (i.e. rest) condition and during reactive hyperemia. The percentage change in diameter (i.e. endothelium-dependent vasodilation) was calculated as percent change=\[(peak diameter-baseline diameter)/baseline diameter\]\*100. Endothelium-dependent vasodilation was determined twice during the study: at completion of 30 days of placebo treatment and at completion of 30 days of sitagliptin treatment.
Outcome measures
| Measure |
Placebo
n=17 Participants
Participants who received Placebo tablet each morning in either the first 30 days or last 30 days of the study.
|
Sitagliptin
n=17 Participants
Participants who received Sitagliptin 100 mg daily each morning in either the first 30 days or last 30 days of the study.
|
|---|---|---|
|
Vascular Function (Endothelium-dependent Vasodilation)
|
13.63 percent change
Standard Deviation 5.27
|
13.00 percent change
Standard Deviation 5.34
|
Adverse Events
Sitagliptin
Placebo
Serious adverse events
| Measure |
Sitagliptin
n=20 participants at risk
Participants received Sitagliptin 100 mg by mouth daily for up to 30 days.
|
Placebo
n=21 participants at risk
Participants received Placebo daily for up to 30 days.
|
|---|---|---|
|
Gastrointestinal disorders
Pancreatitis
|
5.0%
1/20 • Number of events 1 • 30 days for each intervention.
Safety population included all participants who received at least one dose of intervention.
|
0.00%
0/21 • 30 days for each intervention.
Safety population included all participants who received at least one dose of intervention.
|
Other adverse events
| Measure |
Sitagliptin
n=20 participants at risk
Participants received Sitagliptin 100 mg by mouth daily for up to 30 days.
|
Placebo
n=21 participants at risk
Participants received Placebo daily for up to 30 days.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain, Nausea
|
10.0%
2/20 • Number of events 2 • 30 days for each intervention.
Safety population included all participants who received at least one dose of intervention.
|
19.0%
4/21 • Number of events 4 • 30 days for each intervention.
Safety population included all participants who received at least one dose of intervention.
|
|
Gastrointestinal disorders
Emesis
|
0.00%
0/20 • 30 days for each intervention.
Safety population included all participants who received at least one dose of intervention.
|
4.8%
1/21 • Number of events 1 • 30 days for each intervention.
Safety population included all participants who received at least one dose of intervention.
|
|
Nervous system disorders
Dizziness
|
10.0%
2/20 • Number of events 2 • 30 days for each intervention.
Safety population included all participants who received at least one dose of intervention.
|
14.3%
3/21 • Number of events 3 • 30 days for each intervention.
Safety population included all participants who received at least one dose of intervention.
|
|
Nervous system disorders
Headache
|
5.0%
1/20 • Number of events 1 • 30 days for each intervention.
Safety population included all participants who received at least one dose of intervention.
|
0.00%
0/21 • 30 days for each intervention.
Safety population included all participants who received at least one dose of intervention.
|
|
Infections and infestations
Shingles Infection
|
0.00%
0/20 • 30 days for each intervention.
Safety population included all participants who received at least one dose of intervention.
|
4.8%
1/21 • Number of events 1 • 30 days for each intervention.
Safety population included all participants who received at least one dose of intervention.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place