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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04029272
Recruitment Status : Recruiting
First Posted : July 23, 2019
Last Update Posted : July 23, 2019
Sponsor:
Information provided by (Responsible Party):
Aijun Sun, 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.

Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Drug: Metformin Drug: Exenatide 2 MG Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Estimated Study Start Date : July 20, 2019
Estimated Primary Completion Date : February 28, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.

Drug: Metformin
500 mg tid for 12 weeks
Other Name: Glucophage

Experimental: Metformin+EQW

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

Drug: Metformin
500 mg tid for 12 weeks
Other Name: Glucophage

Drug: Exenatide 2 MG
Exenatide injection once weekly for 12 weeks
Other Name: Bydureon




Primary Outcome Measures :
  1. Change in body weight [ Time Frame: Patient's body weight was measured at the baseline and after 12 weeks of clinical trial ]

Secondary Outcome Measures :
  1. Proportion of subjects who lost ≥5% of their body weight [ Time Frame: 12 weeks ]
  2. Proportion of subjects who lost ≥ 10% of their body weight [ Time Frame: 12 weeks ]
  3. Change in body mass index (BMI) [ Time Frame: 12 weeks ]
  4. Change in waist circumference(WC) [ Time Frame: 12 weeks ]
  5. Change in hip circumference (HC) [ Time Frame: 12 weeks ]
  6. Changes in lipid accumulation product(LAP) [ Time Frame: 12 weeks ]
    LAP=(WC(cm)-58)×TG (mmol/L)

  7. Changes in Visceral obesity index(VAI) [ Time Frame: 12 weeks ]
    VAI = (WC(cm)/39.68+(1.88×BMI))×(TG (mmol/l)/1.03)×(1.31/HDL (mmol/l))

  8. Changes in blood pressure [ Time Frame: 12 weeks ]
  9. Changes in Blood Glucose and Insulin During the oral glucose tolerance test (OGTT) [ Time Frame: 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)


  10. Changes in total cholesterol (TC) [ Time Frame: 12 weeks ]
  11. Changes in serum triglyceride (TG) [ Time Frame: 12 weeks ]
  12. Changes in high-density lipoproteincholesterol (HDL-C) [ Time Frame: 12 weeks ]
  13. Changes in low-density lipoproteincholesterol (LDL-C) [ Time Frame: 12 weeks ]
  14. Changes in lipoprotein(a) [ Time Frame: 12 weeks ]
  15. Changes in apolipoprotein a1(ApoA1) [ Time Frame: 12 weeks ]
  16. Changes in apolipoprotein B(ApoB) [ Time Frame: 12 weeks ]
  17. Changes in free fatty acid (FFA) [ Time Frame: 12 weeks ]
  18. Changes in high sensitivity C reactive protein(hsCRP) [ Time Frame: 12 weeks ]
  19. Frequency of menstrual cycle [ Time Frame: 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.

  20. Changes in testosterone [ Time Frame: 12 weeks ]
  21. Changes in Dehydroepiandrosterone sulfate (DHEAS) [ Time Frame: 12 weeks ]
  22. Changes in Luteinizing Hormone (LH) [ Time Frame: 12 weeks ]
  23. Changes in follicle stimulating hormone(FSH) [ Time Frame: 12 weeks ]
  24. Changes in LH/FSH [ Time Frame: 12 weeks ]
  25. Changes in Acne severity score [ Time Frame: 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)

  26. Changes in ovarian volume [ Time Frame: 12 weeks ]
  27. Changes in follicular number of 2-9mm in diameter [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04029272


Contacts
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Contact: Yan Deng 13167559763 yanndeng@163.com
Contact: Aiju Sun

Locations
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China, Beijing
Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China, 1000730
Sponsors and Collaborators
Peking Union Medical College Hospital

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Responsible Party: Aijun Sun, Professor, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT04029272    
Other Study ID Numbers: PCOS201907
First Posted: July 23, 2019    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Aijun Sun, Peking Union Medical College Hospital:
PCOS
GLP-1
GLP-1RA
exenatide
Metformin
glucagon-like peptide 1
glucagon-like peptide 1 receptor agonist
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Syndrome
Overweight
Disease
Pathologic Processes
Body Weight
Signs and Symptoms
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Metformin
Exenatide
Glucagon
Glucagon-Like Peptide 1
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Obesity Agents
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Gastrointestinal Agents