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A before-and-after control study of metformin combined with GLP-1RA or Diane-35 on glucose and lipid metabolism and reproductive function in overweight patients with PCOS

A before-and-after control study of metformin combined with GLP-1RA or Diane-35 on glucose and lipid metabolism and reproductive function in overweight patients with PCOS

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100042388
Enrollment
Unknown
Registered
2021-01-21
Start date
2021-01-25
Completion date
Unknown
Last updated
2021-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic ovary syndrome

Interventions

GLP-1RA group:GlP-1RA in combination with metformin for 3 months
Diane-35 group:Diane-35 in combination with metformin for 3 month, 1 month washout period, GlP-1RA in combination with metformin for 3 months.

Sponsors

Department of Endocrinology, Xinqiao Hospital, the Third Military Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: The diagnostic criteria of PCOS included in the study were PCOS recommended by ESHRE / ASRM of Rotterdam in 2003. That is, the clinical manifestations of rare ovulation or anovulation, hyperandrogenemia or hyperandrogenism, and polycystic ovarian changes under ultrasound can be diagnosed if two of the above three items are met. 1. BMI >= 24kg / m2 or waist circumference >= 85CM. 2. Aged 18 to 50 years.

Exclusion criteria

Exclusion criteria: 1. Patients with PCOS and other infertility diseases; 2. Patients with obvious symptoms and signs of liver and kidney diseases, or ALT 2 times higher than the upper limit of normal, serum creatinine more than 110 mmol / L (1.3 mg / GL); 3. Patients with PLT < 60 * 10 ^ 9 / L and Hb < 100g / L; 4. Patients who can't take effective contraceptive measures during the trial; 5. Patients who had used metformin or other insulin sensitizers within one month before selection; 6. Patients with malignant tumor; 7. Patients with history of vascular disease, thyroid disease, smoking, diabetes and hypertension should be carefully studied; 8. Patients with infection, trauma, surgery and other emergency situations; 9. Patients with cardiovascular disease, thyroid disease, smoking, diabetes and hypertension; 10. There are other cases that can not participate in the completion of intervention follow-up.

Design outcomes

Primary

MeasureTime frame
blood routine examination;thyroid function;Liver and kidney function;sex hormone; fasting blood glucose;glycosylated hemoglobin;fasting insulin;insulin release test;blood lipid;Color doppler ultrasound in gynecology;Glucose clamp test;Inflammatory biomarkers;body mass index;WHR;AMH;

Countries

China

Contacts

Public ContactLiao Mingyu

Department of Endocrinology, Second Affiliated Hospital of Army Medical University (Xinqiao Hospital)

742781319@qq.com+86 13983263460

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026