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.
Recruitment status
COMPLETED
Target enrollment
60 participants
Primary outcome timeframe
24 hours
Results posted on
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=99 Participants
|
29.06 years
STANDARD_DEVIATION 4.25 • n=107 Participants
|
27.95 years
STANDARD_DEVIATION 4.20 • n=206 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
60 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
weight
|
66.36 kilograms
STANDARD_DEVIATION 6.04 • n=99 Participants
|
76.31 kilograms
STANDARD_DEVIATION 8.35 • n=107 Participants
|
71.34 kilograms
STANDARD_DEVIATION 8.80 • n=206 Participants
|
|
height
|
161.73 centimeters
STANDARD_DEVIATION 3.99 • n=99 Participants
|
161.16 centimeters
STANDARD_DEVIATION 4.33 • n=107 Participants
|
161.45 centimeters
STANDARD_DEVIATION 4.14 • n=206 Participants
|
|
body mass index
|
25.4 kilograms per squared meter
STANDARD_DEVIATION 1.90 • n=99 Participants
|
29.4 kilograms per squared meter
STANDARD_DEVIATION 2.86 • n=107 Participants
|
27.4 kilograms per squared meter
STANDARD_DEVIATION 3.14 • n=206 Participants
|
|
parity
para 0
|
20 participants
n=99 Participants
|
13 participants
n=107 Participants
|
33 participants
n=206 Participants
|
|
parity
para 1
|
10 participants
n=99 Participants
|
7 participants
n=107 Participants
|
17 participants
n=206 Participants
|
|
parity
para 2
|
0 participants
n=99 Participants
|
8 participants
n=107 Participants
|
8 participants
n=206 Participants
|
|
parity
para 3
|
0 participants
n=99 Participants
|
2 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
number of abortions
no abortions
|
25 participants
n=99 Participants
|
25 participants
n=107 Participants
|
50 participants
n=206 Participants
|
|
number of abortions
one abortion
|
4 participants
n=99 Participants
|
5 participants
n=107 Participants
|
9 participants
n=206 Participants
|
|
number of abortions
two abortions
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
|
number of abortions
three abortions
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
previous ectopic pregnancies
no ectopic
|
29 participants
n=99 Participants
|
28 participants
n=107 Participants
|
57 participants
n=206 Participants
|
|
previous ectopic pregnancies
previous ectopic
|
1 participants
n=99 Participants
|
2 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
number of living children
no children
|
23 participants
n=99 Participants
|
13 participants
n=107 Participants
|
36 participants
n=206 Participants
|
|
number of living children
one livebirth
|
7 participants
n=99 Participants
|
7 participants
n=107 Participants
|
14 participants
n=206 Participants
|
|
number of living children
two livebirths
|
0 participants
n=99 Participants
|
9 participants
n=107 Participants
|
9 participants
n=206 Participants
|
|
number of living children
three livebirths
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
number of previous cesarean sections
none
|
22 participants
n=99 Participants
|
14 participants
n=107 Participants
|
36 participants
n=206 Participants
|
|
number of previous cesarean sections
one
|
8 participants
n=99 Participants
|
8 participants
n=107 Participants
|
16 participants
n=206 Participants
|
|
number of previous cesarean sections
two
|
0 participants
n=99 Participants
|
7 participants
n=107 Participants
|
7 participants
n=206 Participants
|
|
number of previous cesarean sections
three
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
previous vaginal deliveries
no vaginal deliveries
|
28 participants
n=99 Participants
|
26 participants
n=107 Participants
|
54 participants
n=206 Participants
|
|
previous vaginal deliveries
previous vaginal deliveries
|
2 participants
n=99 Participants
|
4 participants
n=107 Participants
|
6 participants
n=206 Participants
|
|
infertility
no infertility
|
1 participants
n=99 Participants
|
6 participants
n=107 Participants
|
7 participants
n=206 Participants
|
|
infertility
primary infertility
|
19 participants
n=99 Participants
|
12 participants
n=107 Participants
|
31 participants
n=206 Participants
|
|
infertility
secondary infertility
|
10 participants
n=99 Participants
|
12 participants
n=107 Participants
|
22 participants
n=206 Participants
|
|
duration of infertility
|
2 years
n=99 Participants
|
3 years
n=107 Participants
|
2.5 years
n=206 Participants
|
|
Dysmenorrhea
participants having dysmenorrhea
|
27 participants
n=99 Participants
|
11 participants
n=107 Participants
|
38 participants
n=206 Participants
|
|
Dysmenorrhea
participants not having dysmenorrhea
|
3 participants
n=99 Participants
|
19 participants
n=107 Participants
|
22 participants
n=206 Participants
|
|
chronic pelvic pain
participants having chronic pelvic pain
|
9 participants
n=99 Participants
|
4 participants
n=107 Participants
|
13 participants
n=206 Participants
|
|
chronic pelvic pain
participants not having chronic pelvic pain
|
21 participants
n=99 Participants
|
26 participants
n=107 Participants
|
47 participants
n=206 Participants
|
|
Dyspareunia
participants having dyspareunia
|
12 participants
n=99 Participants
|
3 participants
n=107 Participants
|
15 participants
n=206 Participants
|
|
Dyspareunia
participants not having dyspareunia
|
18 participants
n=99 Participants
|
27 participants
n=107 Participants
|
45 participants
n=206 Participants
|
|
Menorrhagia
participants having menorrhagia
|
6 participants
n=99 Participants
|
3 participants
n=107 Participants
|
9 participants
n=206 Participants
|
|
Menorrhagia
participants not having menorrhagia
|
24 participants
n=99 Participants
|
27 participants
n=107 Participants
|
51 participants
n=206 Participants
|
|
categorization of participants according to body mass index
lean
|
16 participants
n=99 Participants
|
3 participants
n=107 Participants
|
19 participants
n=206 Participants
|
|
categorization of participants according to body mass index
overweight
|
13 participants
n=99 Participants
|
13 participants
n=107 Participants
|
26 participants
n=206 Participants
|
|
categorization of participants according to body mass index
obese
|
1 participants
n=99 Participants
|
14 participants
n=107 Participants
|
15 participants
n=206 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
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place