The Association Between Endometriosis, Obesity and nesfatin1

• Sponsor: Ain Shams Maternity Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02683954
• Collaborator: (none)
• Enrollment: 60
• Duration (Months): 10

Study Details

Study Description

Brief Summary

The association between endometriosis, obesity and nesfatin1.

Condition or Disease	Intervention/Treatment	Phase
Endometriosis

Detailed Description

All women in this study were subjected to all of the following:

1. Verbal consent was obtained.

2. History taking:

3. Personal history.

4. Menstrual history.

5. Use of contraception.

6. Use of any hormonal treatment in the three months prior to the laparoscopy.

7. History of infertility and its duration and type.

8. Sexual history.

9. Past history.

10. Complete physical examination: general, abdominal and local gynecological examination.

11. Complete preoperative workout for laparoscopy was done.

12. Laparoscopy was done postmenstrual, during follicular phase. All patients gave an informed consent and were fasting for at least 8 hours prior to the laparoscopy, and general anesthesia was used for all patients.

The pelvis and its structures were observed and checked for presence of endometriotic lesions (uterus, tubes, ovaries and ovarian fossae, uterosacral ligaments, Douglas pouch, uterovesical pouch, broad ligaments and lateral pelvic walls).

The Endometriotic patients were then classified into stages I-IV according to the revised American Fertility Society scoring system for endometriosis.

1. 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.

2. Biopsy from lesions suspected as endometriosis was taken during laparoscopy and sent to histopathology for confirmation.

3. 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.

Patients and Methods

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1. 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.

Study Design

• Study Type: Observational
• Actual Enrollment: 60 participants
• Observational Model: Case-Control
• Time Perspective: Cross-Sectional
• Official Title: The Association Bet Endometriosis, Obesity and nesfatin1
• Study Start Date: Dec 1, 2014
• Actual Primary Completion Date: Oct 1, 2015
• Actual Study Completion Date: Oct 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. Serum Nesfatin 1 [24 hours]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Women in reproductive age group scheduled for laparoscopy for any indication.

Exclusion Criteria:

• Women subject to any hormonal therapy in the last 3 months.

• Women with chronic endocrine disease like diabetes mellitus.

• Women diagnosed with pelvic inflammatory disease (PID).

• Severe medical disorder that prohibits the laparoscopic procedure, such as cardiovascular disease and pulmonary disease.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Ain Shams Maternity Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Amr Ahmed Mahmoud Riad, Lecturer of obstetrics and gynecology, Ain Shams Maternity Hospital
• ClinicalTrials.gov Identifier: NCT02683954
• Other Study ID Numbers: nesfatin 1
• First Posted: Feb 17, 2016
• Last Update Posted: Apr 4, 2016
• Last Verified: Mar 1, 2016

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Additional relevant MeSH terms: Endometriosis

Study Results

Participant Flow

Recruitment Details	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.

Arm/Group Title	Endometriosis	Control
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	30	30
COMPLETED	30	30
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Endometriosis	Control	Total
Arm/Group Description	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.	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 of all reporting groups
Overall Participants	30	30	60
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	26.83 (3.89)	29.06 (4.25)	27.95 (4.20)
Sex: Female, Male (Count of Participants)
Female	30 100%	30 100%	60 100%
Male	0 0%	0 0%	0 0%
weight (kilograms) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kilograms]	66.36 (6.04)	76.31 (8.35)	71.34 (8.80)
height (centimeters) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [centimeters]	161.73 (3.99)	161.16 (4.33)	161.45 (4.14)
body mass index (kilograms per squared meter) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kilograms per squared meter]	25.4 (1.90)	29.4 (2.86)	27.4 (3.14)
parity (participants) [Number]
para 0	20 66.7%	13 43.3%	33 55%
para 1	10 33.3%	7 23.3%	17 28.3%
para 2	0 0%	8 26.7%	8 13.3%
para 3	0 0%	2 6.7%	2 3.3%
number of abortions (participants) [Number]
no abortions	25 83.3%	25 83.3%	50 83.3%
one abortion	4 13.3%	5 16.7%	9 15%
two abortions	0 0%	0 0%	0 0%
three abortions	1 3.3%	0 0%	1 1.7%
previous ectopic pregnancies (participants) [Number]
no ectopic	29 96.7%	28 93.3%	57 95%
previous ectopic	1 3.3%	2 6.7%	3 5%
number of living children (participants) [Number]
no children	23 76.7%	13 43.3%	36 60%
one livebirth	7 23.3%	7 23.3%	14 23.3%
two livebirths	0 0%	9 30%	9 15%
three livebirths	0 0%	1 3.3%	1 1.7%
number of previous cesarean sections (participants) [Number]
none	22 73.3%	14 46.7%	36 60%
one	8 26.7%	8 26.7%	16 26.7%
two	0 0%	7 23.3%	7 11.7%
three	0 0%	1 3.3%	1 1.7%
previous vaginal deliveries (participants) [Number]
no vaginal deliveries	28 93.3%	26 86.7%	54 90%
previous vaginal deliveries	2 6.7%	4 13.3%	6 10%
infertility (participants) [Number]
no infertility	1 3.3%	6 20%	7 11.7%
primary infertility	19 63.3%	12 40%	31 51.7%
secondary infertility	10 33.3%	12 40%	22 36.7%
duration of infertility (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	2	3	2.5
Dysmenorrhea (participants) [Number]
participants having dysmenorrhea	27 90%	11 36.7%	38 63.3%
participants not having dysmenorrhea	3 10%	19 63.3%	22 36.7%
chronic pelvic pain (participants) [Number]
participants having chronic pelvic pain	9 30%	4 13.3%	13 21.7%
participants not having chronic pelvic pain	21 70%	26 86.7%	47 78.3%
Dyspareunia (participants) [Number]
participants having dyspareunia	12 40%	3 10%	15 25%
participants not having dyspareunia	18 60%	27 90%	45 75%
Menorrhagia (participants) [Number]
participants having menorrhagia	6 20%	3 10%	9 15%
participants not having menorrhagia	24 80%	27 90%	51 85%
categorization of participants according to body mass index (participants) [Number]
lean	16 53.3%	3 10%	19 31.7%
overweight	13 43.3%	13 43.3%	26 43.3%
obese	1 3.3%	14 46.7%	15 25%

Outcome Measures

1. Primary Outcome

Title	Serum Nesfatin 1
Description	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.
Time Frame	24 hours

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Endometriosis	Control
Arm/Group Description	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.	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.
Measure Participants	30	30
Median (Inter-Quartile Range) [picogram/millilitre]	190	510

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Endometriosis, Control
	Comments	Normality of numerical data distribution was examined by the Shapiro-Wilk. Normally distributed numerical variables were presented as mean±SD and inter-group differences were compared using unpaired t test. Skewed numerical variables were presented as median and interquartile range and between-group differences were compared using Mann-Whitney U test. Ordinal data were compared using the chi-squared test for trend. Correlations among numerical variables were tested by Spearman rank correlation.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.05
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Adverse Events

Time Frame	All participants were followed up in the hospital for 48 hours and then contacted by phone for another one week till surgical sutures were removed. Then, they were followed by phone for another one month for any adverse events.
Arm/Group Title	Endometriosis		Control
Arm/Group Description	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.		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.
All Cause Mortality
	Endometriosis		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Endometriosis		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/30 (0%)
Other (Not Including Serious) Adverse Events
	Endometriosis		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/30 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.