Metformin vs Metformin Combined With GLP-1RA (Glucagon-like Peptide 1 Receptor Agonist) on Overweight/Obese PCOS Patients

Polycystic Ovary Syndrome Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04029272
• Other study ID #: PCOS201907
• Status: Recruiting
• Phase: Phase 4
• Start date: July 20, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: July 2019
• Source: Peking Union Medical College Hospital
• Contact: Yan Deng
• Phone: 13167559763
• Email: yanndeng[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2020
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Overweight
• Polycystic Ovary Syndrome
• Syndrome

Intervention

Drug:
• Metformin
500 mg tid for 12 weeks
• Exenatide 2 MG
Exenatide injection once weekly for 12 weeks

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in body weight		Patient's body weight was measured at the baseline and after 12 weeks of clinical trial
Secondary	Proportion of subjects who lost =5% of their body weight		12 weeks
Secondary	Proportion of subjects who lost = 10% of their body weight		12 weeks
Secondary	Change in body mass index (BMI)		12 weeks
Secondary	Change in waist circumference(WC)		12 weeks
Secondary	Change in hip circumference (HC)		12 weeks
Secondary	Changes in lipid accumulation product(LAP)	LAP=(WC(cm)-58)×TG (mmol/L)	12 weeks
Secondary	Changes in Visceral obesity index(VAI)	VAI = (WC(cm)/39.68+(1.88×BMI))×(TG (mmol/l)/1.03)×(1.31/HDL (mmol/l))	12 weeks
Secondary	Changes in blood pressure		12 weeks
Secondary	Changes in Blood Glucose and Insulin During the oral glucose tolerance test (OGTT)	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-ß=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)); ?I30/?G30 = (Ins30- Ins0)/( Glu30- Glu0)	12 weeks
Secondary	Changes in total cholesterol (TC)		12 weeks
Secondary	Changes in serum triglyceride (TG)		12 weeks
Secondary	Changes in high-density lipoproteincholesterol (HDL-C)		12 weeks
Secondary	Changes in low-density lipoproteincholesterol (LDL-C)		12 weeks
Secondary	Changes in lipoprotein(a)		12 weeks
Secondary	Changes in apolipoprotein a1(ApoA1)		12 weeks
Secondary	Changes in apolipoprotein B(ApoB)		12 weeks
Secondary	Changes in free fatty acid (FFA)		12 weeks
Secondary	Changes in high sensitivity C reactive protein(hsCRP)		12 weeks
Secondary	Frequency of menstrual cycle	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.	12 weeks
Secondary	Changes in testosterone		12 weeks
Secondary	Changes in Dehydroepiandrosterone sulfate (DHEAS)		12 weeks
Secondary	Changes in Luteinizing Hormone (LH)		12 weeks
Secondary	Changes in follicle stimulating hormone(FSH)		12 weeks
Secondary	Changes in LH/FSH		12 weeks
Secondary	Changes in Acne severity score	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)	12 weeks
Secondary	Changes in ovarian volume		12 weeks
Secondary	Changes in follicular number of 2-9mm in diameter		12 weeks