Clinical trial NCT04029272: Metformin vs Metformin Combined With GLP-1RA (Glucagon-like Peptide 1 Receptor Agonist) on Overweight/Obese PCOS Patients
Official title: Study on the Effect of Metformin vs Metformin Combined With GLP-1 RA (Exenatide) on Overweight/Obese Patients With Polycystic Ovary Syndrome (PCOS)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Polycystic Ovary Syndrome
Keywords: PCOS
GLP-1
GLP-1RA
exenatide
Metformin
glucagon-like peptide 1
glucagon-like peptide 1 receptor agonist
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2019-07-23
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to determine whether metformin combined with exenatide once weekly (EQW) is more effective than metformin alone in the treatment of overweight/obese women with polycystic ovary syndrome (PCOS). Background therapies were Diane-35 or/and progesterone capsule. 80 participants were randomized to use either metformin or metformin+EQW for 12 weeks. Greater changes in body weight were anticipated in patients treated with EQW+metformin than metformin alone in those treated with metformin.


Eligibility criteria: Inclusion Criteria:

* Females 18 years to 40 years of age
* Diagnosed as PCOS by the 2003 Rotterdam criteria.
* Overweight/obesity (BMI≥25 kg/m2)
* No pregnant plan in recent 6 months
* Written consent for participation in the study

Exclusion Criteria:

* type 1 or type 2 diabetes mellitus
* Subjects have other endocrine diseases, such as adrenal hyperplasias or tumor, androgen-secreting tumors, Cushing's syndrome, thyroid diseases, and hyperprolactinemia
* Diagnosed with or have a family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
* Serious systemic disease or malignant tumor
* History of pancreatitis (chronic, acute or recurrent)
* Body weight change ≥10% at 3 months before treatment
* Used oral contraceptives or sex hormone drugs in the past 1 month
* Used oral glucocorticoids in the past 1 month
* Substance (alcohol or drug) abuse or dependence within 3 months; Heavy smokers (smokers who smoke 20 or more cigarettes a day) or heavy drinkers (\>10g/d)
* Subjects have a severe systemic disease, such as cardiovascular system
* Renal impairment, eGFR\<60ml/min/1.73m2
* Increase of transaminases up to \< 2.5 times of upper limit of normal value
* Have a history of thromboembolic disease or thrombotic tendency
* Subjects in pregnant or lactating or within 1 year after delivery.
* Subjects have an allergic history to the drugs used in the study
* Subjects have participated in other clinical researches of medicine within 1 month prior to randomization.
* Use of metformin, glucagon-like peptide -1 receptor agonists, or weight loss medications (prescription or OTC) within 30 days before screening.

Primary outcomes:
measure: Change in body weight
timeFrame: Patient's body weight was measured at the baseline and after 12 weeks of clinical trial
Secondary outcomes:
measure: Proportion of subjects who lost ≥5% of their body weight
timeFrame: 12 weeks
measure: Proportion of subjects who lost ≥ 10% of their body weight
timeFrame: 12 weeks
measure: Change in body mass index (BMI)
timeFrame: 12 weeks
measure: Change in waist circumference(WC)
timeFrame: 12 weeks
measure: Change in hip circumference (HC)
timeFrame: 12 weeks
measure: Changes in lipid accumulation product(LAP)
timeFrame: 12 weeks
measure: Changes in Visceral obesity index(VAI)
timeFrame: 12 weeks
measure: Changes in blood pressure
timeFrame: 12 weeks
measure: Changes in Blood Glucose and Insulin During the oral glucose tolerance test (OGTT)
timeFrame: 12 weeks
measure: Changes in total cholesterol (TC)
timeFrame: 12 weeks
measure: Changes in serum triglyceride (TG)
timeFrame: 12 weeks
measure: Changes in high-density lipoproteincholesterol (HDL-C)
timeFrame: 12 weeks
measure: Changes in low-density lipoproteincholesterol (LDL-C)
timeFrame: 12 weeks
measure: Changes in lipoprotein(a)
timeFrame: 12 weeks
measure: Changes in apolipoprotein a1(ApoA1)
timeFrame: 12 weeks
measure: Changes in apolipoprotein B(ApoB)
timeFrame: 12 weeks
measure: Changes in free fatty acid (FFA)
timeFrame: 12 weeks
measure: Changes in high sensitivity C reactive protein(hsCRP)
timeFrame: 12 weeks
measure: Frequency of menstrual cycle
timeFrame: 12 weeks
measure: Changes in testosterone
timeFrame: 12 weeks
measure: Changes in Dehydroepiandrosterone sulfate (DHEAS)
timeFrame: 12 weeks
measure: Changes in Luteinizing Hormone (LH)
timeFrame: 12 weeks
measure: Changes in follicle stimulating hormone(FSH)
timeFrame: 12 weeks
measure: Changes in LH/FSH
timeFrame: 12 weeks
measure: Changes in Acne severity score
timeFrame: 12 weeks
measure: Changes in ovarian volume
timeFrame: 12 weeks
measure: Changes in follicular number of 2-9mm in diameter
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
References:
citation: Ma RL, Deng Y, Wang YF, Zhu SY, Ding XS, Sun AJ. Short-term combined treatment with exenatide and metformin for overweight/obese women with polycystic ovary syndrome. Chin Med J (Engl). 2021 Nov 3;134(23):2882-2889. doi: 10.1097/CM9.0000000000001712.