Ignite Creation Date:
2024-05-06 @ 7:27 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06015594
Status:
COMPLETED
Last Update Posted:
2023-08-29
First Post:
2023-08-03
Brief Title:
Metformin Treatment in Adolescent Patients With PCOS A Long-term Winning Metabolic Choice
Sponsor:
University of Cagliari
Organization:
University of Cagliari
Study Overview
Official Title:
Metformin Treatment in Adolescent Patients With PCOS A Long-term Winning Metabolic Choice Results From a Single Center 5-years Retrospective Clinical Study
Status:
COMPLETED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aimed to understand whether metformin therapy can improve insulin resistance in adolescent PCOS patients both during treatment and after discontinuation and to evaluate its action on the hormonal and metabolic pathways
Detailed Description:
Data were retrospectively retrieved from a database of clinical data collected in the Outpatient Pediatric and Adolescent Gynecology Clinic of the University Hospital Duilio Casula Monserrato Cagliari Division of Gynecology and Obstetrics Department of Surgical Sciences University of Cagliari Italy between 2015 and 2019 PCOS diagnosis was adapted for age following the 2019 update from Witchel SF and Carminas recommendation
The population consisted of 168 PCOS patients aged 12 to 17 Clinical examination medical history blood sampling and pelvic ultrasound US were performed The number of post-menarche years and the body mass index BMI were collected
The patients were subjected to physical examination to evaluate hirsutism according to the criteria of the Ferriman and Gallwey score as well as acne using the Cremoncini classification
Each participant received detailed advice on improving their lifestyle such as physical activity and nutrition Investigators gave indications of the various food and their weighted intake and a balanced composition of macronutrients carbohydrates 55 lipids 25 protein 20 fiber 25 gday as recommended by the Reference intake levels of nutrients and energy for the Italian population LARN guidelines Vegetables fruit cereals fish and pulses typical of the Mediterranean style were included in the diet
Investigators recommended 150 minutes per week of moderate or 75 minutes of vigorous-intensity exercise for weight gain prevention minimizing sedentary time and including strength training exercises for two days per week as reported from the 2018 PCOS guideline
Laboratory evaluations were performed during the menstrual cycles first follicular phase days 3-7 and after a fast of 10-12 hours Menstrual bleeding was induced by administering medroxyprogesterone acetate 10 mgday for five days in amenorrhoeic patients
Follicle-stimulating hormone FSH luteinizing hormone LH 17-β estradiol E2 total testosterone TT delta-4-androstenedione A 17-hydroxyprogesterone 17-OH-P and sex hormone binding globulin SHBG were tested In addition total cholesterol HDL LDL and triglycerides were measured with these blood tests
The following day the patients underwent a 75 g oral glucose tolerance test OGTT The OGTT was performed at 9 am after fasting overnight Blood samples were collected basally and 60 90 120 and 180 min after ingesting 75 g of glucose in 150 ml of water Insulin and glucose were assayed in all samples Serum E2 FSH LH and TT were measured by chemiluminescence immunoassay Immulite Siemens Products Corporation Los Angeles CA Enzymatic methods were used for glucose cholesterol and triglycerides determination Radioimmunoassay RIA was used to measure serum A insulin and 17-OHP Diagnostic System Laboratories Inc DSL Webster TX Insulin and glucose values were expressed as the area under the curve AUC The AUC was calculated using the trapezoidal rule method and reported as mIUml times 180 min for insulin
A normal glycemic response to OGTT was defined according to the criteria of the National Diabetes Data Group 1979
As previously described a normal insulinemic response to OGTT was defined by a threshold AUC value of 16900 mIU ml 180 min
Insulin sensitivity evaluation was estimated using the homeostatic model assessment index HOMA which was calculated as follows HOMA fasting insulin mUml fasting glucose mmoll22 5
The same operator acquired ovarian morphology and ovarian volume for all patients Ultrasound was performed by a transabdominal probe in a whole bladder or transvaginally A Voluson E6 ultrasound system equipped with a 2-8 MHz RAB4-8-D convex transducer GE Medical Systems Austria was used for the investigation The ultrasound examination was performed on the same day the blood samples were taken Ovarian volume was calculated using the formula for a modified prolate ellipsoid longitudinal x transverse x anterior-posterior 05233 The mean volume values of both ovaries were included in the statistical analysis
Participants were categorized into two groups the study group consisting of patients who received metformin therapy and the control group which did not receive metformin during the study period
The metformin dose was determined based on the study by Fulghesu et al Both the study and control group underwent the same combined oral contraceptive pills COCs containing drospirenone 3 mgethinyl estradiol 20 μg 3 mg DRSP20 μg EE-244
Follow-up was performed every 3-6 months in the first year then after 12 months by OGTT and clinical evaluation
After about 24 months of treatment the patients returned to the hospital and repeated clinical and laboratory examinations Finally the patients repeated the same blood tests and overall assessment at least 24 months after discontinuing metformin therapy Baseline data are expressed as b-AUC b-HOMA and b-BMI End-of-therapy evaluation data are described as e-AUC e-HOMA and e-BMI
Evaluation data after the end of therapy are reported as ae-AUC ae-HOMA and ae-BMI
Patient data were collected anonymously on an Excel database Office 365 Statistical analysis was performed using the IBM SPSS Statistics statistical software version 26 IBM SPSS Statistics Chicago IL USA Measurement data corresponding to the normal distribution were expressed by mean SD and the t-test was used for the paired samples Students t-test In addition the count data were expressed as n and the beta coefficient of linear regression with a 95 confidence interval 95 CI was reported for each analysis In all calculations a p-value 005 was considered significant
The population consisted of 168 PCOS patients aged 12 to 17 Clinical examination medical history blood sampling and pelvic ultrasound US were performed The number of post-menarche years and the body mass index BMI were collected
The patients were subjected to physical examination to evaluate hirsutism according to the criteria of the Ferriman and Gallwey score as well as acne using the Cremoncini classification
Each participant received detailed advice on improving their lifestyle such as physical activity and nutrition Investigators gave indications of the various food and their weighted intake and a balanced composition of macronutrients carbohydrates 55 lipids 25 protein 20 fiber 25 gday as recommended by the Reference intake levels of nutrients and energy for the Italian population LARN guidelines Vegetables fruit cereals fish and pulses typical of the Mediterranean style were included in the diet
Investigators recommended 150 minutes per week of moderate or 75 minutes of vigorous-intensity exercise for weight gain prevention minimizing sedentary time and including strength training exercises for two days per week as reported from the 2018 PCOS guideline
Laboratory evaluations were performed during the menstrual cycles first follicular phase days 3-7 and after a fast of 10-12 hours Menstrual bleeding was induced by administering medroxyprogesterone acetate 10 mgday for five days in amenorrhoeic patients
Follicle-stimulating hormone FSH luteinizing hormone LH 17-β estradiol E2 total testosterone TT delta-4-androstenedione A 17-hydroxyprogesterone 17-OH-P and sex hormone binding globulin SHBG were tested In addition total cholesterol HDL LDL and triglycerides were measured with these blood tests
The following day the patients underwent a 75 g oral glucose tolerance test OGTT The OGTT was performed at 9 am after fasting overnight Blood samples were collected basally and 60 90 120 and 180 min after ingesting 75 g of glucose in 150 ml of water Insulin and glucose were assayed in all samples Serum E2 FSH LH and TT were measured by chemiluminescence immunoassay Immulite Siemens Products Corporation Los Angeles CA Enzymatic methods were used for glucose cholesterol and triglycerides determination Radioimmunoassay RIA was used to measure serum A insulin and 17-OHP Diagnostic System Laboratories Inc DSL Webster TX Insulin and glucose values were expressed as the area under the curve AUC The AUC was calculated using the trapezoidal rule method and reported as mIUml times 180 min for insulin
A normal glycemic response to OGTT was defined according to the criteria of the National Diabetes Data Group 1979
As previously described a normal insulinemic response to OGTT was defined by a threshold AUC value of 16900 mIU ml 180 min
Insulin sensitivity evaluation was estimated using the homeostatic model assessment index HOMA which was calculated as follows HOMA fasting insulin mUml fasting glucose mmoll22 5
The same operator acquired ovarian morphology and ovarian volume for all patients Ultrasound was performed by a transabdominal probe in a whole bladder or transvaginally A Voluson E6 ultrasound system equipped with a 2-8 MHz RAB4-8-D convex transducer GE Medical Systems Austria was used for the investigation The ultrasound examination was performed on the same day the blood samples were taken Ovarian volume was calculated using the formula for a modified prolate ellipsoid longitudinal x transverse x anterior-posterior 05233 The mean volume values of both ovaries were included in the statistical analysis
Participants were categorized into two groups the study group consisting of patients who received metformin therapy and the control group which did not receive metformin during the study period
The metformin dose was determined based on the study by Fulghesu et al Both the study and control group underwent the same combined oral contraceptive pills COCs containing drospirenone 3 mgethinyl estradiol 20 μg 3 mg DRSP20 μg EE-244
Follow-up was performed every 3-6 months in the first year then after 12 months by OGTT and clinical evaluation
After about 24 months of treatment the patients returned to the hospital and repeated clinical and laboratory examinations Finally the patients repeated the same blood tests and overall assessment at least 24 months after discontinuing metformin therapy Baseline data are expressed as b-AUC b-HOMA and b-BMI End-of-therapy evaluation data are described as e-AUC e-HOMA and e-BMI
Evaluation data after the end of therapy are reported as ae-AUC ae-HOMA and ae-BMI
Patient data were collected anonymously on an Excel database Office 365 Statistical analysis was performed using the IBM SPSS Statistics statistical software version 26 IBM SPSS Statistics Chicago IL USA Measurement data corresponding to the normal distribution were expressed by mean SD and the t-test was used for the paired samples Students t-test In addition the count data were expressed as n and the beta coefficient of linear regression with a 95 confidence interval 95 CI was reported for each analysis In all calculations a p-value 005 was considered significant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None