Metformin vs Metformin Combined With GLP-1RA (Glucagon-like Peptide 1 Receptor Agonist) on Overweight/Obese PCOS Patients
- Registration Number
- NCT04029272
- Lead Sponsor
- Peking Union Medical College Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 80
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Metformin Metformin Background therapy: Diane-35 one pill by mouth, once daily, beginning on Day 5 of the menstrual cycle for 21 consecutive days followed by a 7-day interval without medication; for three cycles (3 months) Metformin: Metformin was initiated at a dose of 250mg q.d. and increased by 250mg up to 500 mg t.i.d. Metformin+EQW Metformin Background therapy: Diane-35 one pill by mouth, once daily, beginning on Day 5 of the menstrual cycle for 21 consecutive days followed by a 7-day interval without medication; for three cycles (3 months) Metformin: Metformin was initiated at a dose of 250mg q.d. and increased by 250mg up to 500 mg t.i.d. EQW: Participants will receive long-acting Exenatide once a week for 12 weeks Metformin+EQW Exenatide 2 MG Background therapy: Diane-35 one pill by mouth, once daily, beginning on Day 5 of the menstrual cycle for 21 consecutive days followed by a 7-day interval without medication; for three cycles (3 months) Metformin: Metformin was initiated at a dose of 250mg q.d. and increased by 250mg up to 500 mg t.i.d. EQW: Participants will receive long-acting Exenatide once a week for 12 weeks
- Primary Outcome Measures
Name Time Method Change in body weight Patient's body weight was measured at the baseline and after 12 weeks of clinical trial
- Secondary Outcome Measures
Name Time Method Proportion of subjects who lost ≥ 10% of their body weight 12 weeks Proportion of subjects who lost ≥5% of their body weight 12 weeks Change in body mass index (BMI) 12 weeks Change in waist circumference(WC) 12 weeks Change in hip circumference (HC) 12 weeks Changes in lipid accumulation product(LAP) 12 weeks LAP=(WC(cm)-58)×TG (mmol/L)
Changes in Visceral obesity index(VAI) 12 weeks VAI = (WC(cm)/39.68+(1.88×BMI))×(TG (mmol/l)/1.03)×(1.31/HDL (mmol/l))
Changes in blood pressure 12 weeks Changes in Blood Glucose and Insulin During the oral glucose tolerance test (OGTT) 12 weeks glucose obtained at 0,30,60 and 120 minutes during the OGTT. HOMA-IR=Glu0(mmol/l)×Ins0(mU/ml)/22.5
Matsuda index=1000/ square(Ins0 (mU/ml) ×Glu0 (mmol/l)×mean Glu(mmol/l)×meanIns(mU/ml)\]
QUICKI= 1/Log\[Glu0 (mU/ml) ×Ins0 (mmol/l)\]
HOMA-β=20×Ins0 (mU/ml) /(Glu0 (mmol/l)-3.5)
MBCI= Ins0 (mU/ml)×Glu0(mmol/l)／(Glu120(mmol/l)＋Glu60 (mmol/l)-2×Glu0 (mmol/l)）
ΔI30/ΔG30 = (Ins30- Ins0)/( Glu30- Glu0)Changes in total cholesterol (TC) 12 weeks Changes in serum triglyceride (TG) 12 weeks Changes in high-density lipoproteincholesterol (HDL-C) 12 weeks Changes in low-density lipoproteincholesterol (LDL-C) 12 weeks Changes in lipoprotein(a) 12 weeks Changes in apolipoprotein a1(ApoA1) 12 weeks Changes in apolipoprotein B(ApoB) 12 weeks Changes in free fatty acid (FFA) 12 weeks Changes in high sensitivity C reactive protein(hsCRP) 12 weeks Frequency of menstrual cycle 12 weeks The number of menstrual cycles during the previous year was recorded and the menstrual cycle ratio calculated by dividing 12 by the number of menstrual cycles in the previous year . During the study period, the patients in a menstrual diary recorded vaginal bleeding over 12 weeks. The effects of treatment intervention on menstrual cycle interval was calculated evaluated by dividing 3 by the number of menstrual cycles recorded in each patient's menstrual cycle diary.
Changes in testosterone 12 weeks Changes in Dehydroepiandrosterone sulfate (DHEAS) 12 weeks Changes in Luteinizing Hormone (LH) 12 weeks Changes in follicle stimulating hormone(FSH) 12 weeks Changes in LH/FSH 12 weeks Changes in Acne severity score 12 weeks This system divides the face, chest, and upper back into 6 areas: the forehead, right cheek,left cheek, nose, chin, and torso (chest and upper back combined). Each acne lesion is described and scored as a comedo (1 point), papule (2 points), pustule (3 points), or nodule (4 points); absence of an acne lesion in an area results in a score of 0 points. The local score for each anatomic area is determined by multiplying the score of the most severe lesion by an area factor (1 to 3), and the local scores of the 6 areas are then added together to obtain the total score. Acne severity is graded as none (total score, 0 points), mild (total score, 1-18 points), moderate (total score, 19-30 points), severe (total score, 31-38 points), and very severe (total score N38 points)
Changes in ovarian volume 12 weeks Changes in follicular number of 2-9mm in diameter 12 weeks
Trial Locations
- Locations (1)
Peking Union Medical College Hospital
🇨🇳Beijing, Beijing, China