Trial Outcomes & Findings for The Association Between Endometriosis, Obesity and nesfatin1 (NCT NCT02683954)
NCT ID: NCT02683954
Last Updated: 2016-04-04
Results Overview
Venous samples for measurement of nesfatin-1 were taken by venipuncture from patients during the laparoscopy procedure immediately after initial evaluation and before any intervention.The blood samples were centrifuged immediately after their collection at 5000 rpm for 10 min and serum samples were stored at -20 °C until analysis. Nesfatin-1 was measured by Enzyme-Linked Immuno Sorbent Assay "ELISA" technique using commercially available kits (Boster Biological Technology Human Nesfatin-1 ELISA kits, Catalog number EK1138, USA) in the Central Labs of Ain Shams University Hospitals.
COMPLETED
60 participants
24 hours
2016-04-04
Participant Flow
This study was conducted in Ain Shams University Maternity Hospital, during the period from December 2014 till October 2015. After approval of the research and ethics committee and, sixty patients were admitted to the wards to undergo laparoscopy for various indications and were included in this study.
Participant milestones
| Measure |
Endometriosis
30 women with laparoscopically diagnosed endometriosis. This group will be categorized into 3 sub-groups according to the BMI: i) Lean: BMI \<25.0 kg/m2. ii) Overweight: BMI ≥25.0 kg/m2 but less than 30 kg/m2. iii) Obese: BMI ≥30 kg/m2.
|
Control
30 women without any laparoscopically detected pelvic endometriotic pathology. This group will be categorized into 3 sub-groups according to the BMI: i) Lean: BMI \<25.0 kg/m2. ii) Overweight: BMI ≥25.0 kg/m2 but less than 30 kg/m2. iii) Obese: BMI ≥30 kg/m2.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
30
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Association Between Endometriosis, Obesity and nesfatin1
Baseline characteristics by cohort
| Measure |
Endometriosis
n=30 Participants
30 women with laparoscopically diagnosed endometriosis. This group will be categorized into 3 sub-groups according to the BMI: i) Lean: BMI \<25.0 kg/m2. ii) Overweight: BMI ≥25.0 kg/m2 but less than 30 kg/m2. iii) Obese: BMI ≥30 kg/m2.
|
Control
n=30 Participants
30 women without any laparoscopically detected pelvic endometriotic pathology. This group will be categorized into 3 sub-groups according to the BMI: i) Lean: BMI \<25.0 kg/m2. ii) Overweight: BMI ≥25.0 kg/m2 but less than 30 kg/m2. iii) Obese: BMI ≥30 kg/m2.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
26.83 years
STANDARD_DEVIATION 3.89 • n=5 Participants
|
29.06 years
STANDARD_DEVIATION 4.25 • n=7 Participants
|
27.95 years
STANDARD_DEVIATION 4.20 • n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
weight
|
66.36 kilograms
STANDARD_DEVIATION 6.04 • n=5 Participants
|
76.31 kilograms
STANDARD_DEVIATION 8.35 • n=7 Participants
|
71.34 kilograms
STANDARD_DEVIATION 8.80 • n=5 Participants
|
|
height
|
161.73 centimeters
STANDARD_DEVIATION 3.99 • n=5 Participants
|
161.16 centimeters
STANDARD_DEVIATION 4.33 • n=7 Participants
|
161.45 centimeters
STANDARD_DEVIATION 4.14 • n=5 Participants
|
|
body mass index
|
25.4 kilograms per squared meter
STANDARD_DEVIATION 1.90 • n=5 Participants
|
29.4 kilograms per squared meter
STANDARD_DEVIATION 2.86 • n=7 Participants
|
27.4 kilograms per squared meter
STANDARD_DEVIATION 3.14 • n=5 Participants
|
|
parity
para 0
|
20 participants
n=5 Participants
|
13 participants
n=7 Participants
|
33 participants
n=5 Participants
|
|
parity
para 1
|
10 participants
n=5 Participants
|
7 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
parity
para 2
|
0 participants
n=5 Participants
|
8 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
parity
para 3
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
number of abortions
no abortions
|
25 participants
n=5 Participants
|
25 participants
n=7 Participants
|
50 participants
n=5 Participants
|
|
number of abortions
one abortion
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
number of abortions
two abortions
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
number of abortions
three abortions
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
previous ectopic pregnancies
no ectopic
|
29 participants
n=5 Participants
|
28 participants
n=7 Participants
|
57 participants
n=5 Participants
|
|
previous ectopic pregnancies
previous ectopic
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
number of living children
no children
|
23 participants
n=5 Participants
|
13 participants
n=7 Participants
|
36 participants
n=5 Participants
|
|
number of living children
one livebirth
|
7 participants
n=5 Participants
|
7 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
number of living children
two livebirths
|
0 participants
n=5 Participants
|
9 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
number of living children
three livebirths
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
number of previous cesarean sections
none
|
22 participants
n=5 Participants
|
14 participants
n=7 Participants
|
36 participants
n=5 Participants
|
|
number of previous cesarean sections
one
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
number of previous cesarean sections
two
|
0 participants
n=5 Participants
|
7 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
number of previous cesarean sections
three
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
previous vaginal deliveries
no vaginal deliveries
|
28 participants
n=5 Participants
|
26 participants
n=7 Participants
|
54 participants
n=5 Participants
|
|
previous vaginal deliveries
previous vaginal deliveries
|
2 participants
n=5 Participants
|
4 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
infertility
no infertility
|
1 participants
n=5 Participants
|
6 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
infertility
primary infertility
|
19 participants
n=5 Participants
|
12 participants
n=7 Participants
|
31 participants
n=5 Participants
|
|
infertility
secondary infertility
|
10 participants
n=5 Participants
|
12 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
duration of infertility
|
2 years
n=5 Participants
|
3 years
n=7 Participants
|
2.5 years
n=5 Participants
|
|
Dysmenorrhea
participants having dysmenorrhea
|
27 participants
n=5 Participants
|
11 participants
n=7 Participants
|
38 participants
n=5 Participants
|
|
Dysmenorrhea
participants not having dysmenorrhea
|
3 participants
n=5 Participants
|
19 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
chronic pelvic pain
participants having chronic pelvic pain
|
9 participants
n=5 Participants
|
4 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
chronic pelvic pain
participants not having chronic pelvic pain
|
21 participants
n=5 Participants
|
26 participants
n=7 Participants
|
47 participants
n=5 Participants
|
|
Dyspareunia
participants having dyspareunia
|
12 participants
n=5 Participants
|
3 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Dyspareunia
participants not having dyspareunia
|
18 participants
n=5 Participants
|
27 participants
n=7 Participants
|
45 participants
n=5 Participants
|
|
Menorrhagia
participants having menorrhagia
|
6 participants
n=5 Participants
|
3 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Menorrhagia
participants not having menorrhagia
|
24 participants
n=5 Participants
|
27 participants
n=7 Participants
|
51 participants
n=5 Participants
|
|
categorization of participants according to body mass index
lean
|
16 participants
n=5 Participants
|
3 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
categorization of participants according to body mass index
overweight
|
13 participants
n=5 Participants
|
13 participants
n=7 Participants
|
26 participants
n=5 Participants
|
|
categorization of participants according to body mass index
obese
|
1 participants
n=5 Participants
|
14 participants
n=7 Participants
|
15 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 hoursPopulation: In the endometriosis group, two patients were stage I, one was stage II, 12 were stage III and 15 were stage IV according to the revised ASRM scoring system. In the control group, 13 had polycystic varies, 11 had variable pelvic peritoneal adhesions, 4 had tubal block , one had unilateral ovarian cyst and one patient had atrophic ovaries.
Venous samples for measurement of nesfatin-1 were taken by venipuncture from patients during the laparoscopy procedure immediately after initial evaluation and before any intervention.The blood samples were centrifuged immediately after their collection at 5000 rpm for 10 min and serum samples were stored at -20 °C until analysis. Nesfatin-1 was measured by Enzyme-Linked Immuno Sorbent Assay "ELISA" technique using commercially available kits (Boster Biological Technology Human Nesfatin-1 ELISA kits, Catalog number EK1138, USA) in the Central Labs of Ain Shams University Hospitals.
Outcome measures
| Measure |
Endometriosis
n=30 Participants
30 women with laparoscopically diagnosed endometriosis. This group will be categorized into 3 sub-groups according to the BMI: i) Lean: BMI \<25.0 kg/m2. ii) Overweight: BMI ≥25.0 kg/m2 but less than 30 kg/m2. iii) Obese: BMI ≥30 kg/m2.
|
Control
n=30 Participants
30 women without any laparoscopically detected pelvic endometriotic pathology. This group will be categorized into 3 sub-groups according to the BMI: i) Lean: BMI \<25.0 kg/m2. ii) Overweight: BMI ≥25.0 kg/m2 but less than 30 kg/m2. iii) Obese: BMI ≥30 kg/m2.
|
|---|---|---|
|
Serum Nesfatin 1
|
190 picogram/millilitre
Interval 150.0 to 280.0
|
510 picogram/millilitre
Interval 410.0 to 600.0
|
Adverse Events
Endometriosis
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place