Trial Outcomes & Findings for Fibroblast Growth Factors 19 and 21 in Gestational Diabetes Mellitus (NCT NCT01858597)
NCT ID: NCT01858597
Last Updated: 2023-05-30
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
90 participants
Primary outcome timeframe
in fasting state during 24-28 gestational weeks
Results posted on
2023-05-30
Participant Flow
Participant milestones
| Measure |
Gestational Diabetes Mellitus
Women with gestational diabetes mellitus.
|
Control
Women with normal glucose tolerance.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
60
|
|
Overall Study
COMPLETED
|
30
|
60
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Fibroblast Growth Factors 19 and 21 in Gestational Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
Gestational Diabetes Mellitus
n=30 Participants
Women with gestational diabetes.
|
Control
n=60 Participants
Women with normal glucose tolerance.
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=39 Participants
|
60 Participants
n=41 Participants
|
90 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=39 Participants
|
60 Participants
n=41 Participants
|
90 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Region of Enrollment
China
|
30 participants
n=39 Participants
|
60 participants
n=41 Participants
|
90 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: in fasting state during 24-28 gestational weeksOutcome measures
| Measure |
Gestational Diabetes Mellitus
n=30 Participants
Women with gestational diabetes mellitus.
|
Control
n=60 Participants
Women with normal glucose tolerance.
|
|---|---|---|
|
The Concentration of Serum FGF19
|
65.96 pg/mL
Interval 51.76 to 90.11
|
124.47 pg/mL
Interval 82.72 to 189.5
|
SECONDARY outcome
Timeframe: term delivery (when participants come back to hospital to give birth during 37-41 gestational weeks)Population: In this study we included 90 cases with serum samples as well as 45 term deliveries with placenta samples. The secondary outcome was to analyze the expression of FGF19 in term placenta, therefore only 45 cases were included.
Outcome measures
| Measure |
Gestational Diabetes Mellitus
n=20 Participants
Women with gestational diabetes mellitus.
|
Control
n=25 Participants
Women with normal glucose tolerance.
|
|---|---|---|
|
Expression of FGF19 in Term Placenta
|
0.33 pg/mL
Standard Deviation 0.05
|
0.72 pg/mL
Standard Deviation 0.09
|
Adverse Events
Gestational Diabetes Mellitus
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Director of Clinical Trials
The first Affiliated Hospital of Sun-Yat Sen University
Phone: 86-020-28823388
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place