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Efficacy of very low carbohydrate diet combined with metformin in overweight / obese PCOS patients on changing of clinical phenotype, gut microbiota and plasma metabolome after treatment: a randomized, controlled clinical trial

Efficacy of very low carbohydrate diet combined with metformin in overweight / obese PCOS patients on changing of clinical phenotype, gut microbiota and plasma metabolome after treatment: a randomized, controlled clinical trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100048315
Enrollment
Unknown
Registered
2021-07-05
Start date
2021-07-03
Completion date
Unknown
Last updated
2022-03-14

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

Conditions

Polycystic ovary syndrome

Interventions

Group A:Very low carbohydrate diet intervention was given
Group B:Very low carbohydrate diet and metformin intervention were given

Sponsors

The First Affiliated Hospital of Shantou University Medical College
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
25 Years to 35 Years

Inclusion criteria

Inclusion criteria: 1. PCOS diagnostic criteria: according to the Rotterdam criteria, meet: menstrual thinning or anovulation; Clinical manifestations or biochemical evidence of hyperandrogenemia; Ovarian ultrasound showed that the number of vesicles with a diameter of 2-9mm on each side was greater than or equal to 12, which met the criteria of more than 2, and excluded congenital adrenal hyperplasia (CAH), Cushing syndrome, hyperprolactinemia and thyroid dysfunction; 2. Aged 25 to 35 years; 3. BMI 26-32kg/m^2 4. No PCOS related treatment (including Diane-35, metformin, etc.) in the past year.

Exclusion criteria

Exclusion criteria: 1.Patients with chronic diseases such as diabetes, hypertension and connective tissue disease need long-term medication; 2.Patients with endocrine diseases such as thyroid, adrenal and gonadal diseases who need long-term medication; 3.Patients with intestinal diseases such as inflammatory bowel disease, or receiving intestinal surgery; 4.Severe liver, kidney and heart dysfunction; 5.Patients used antibiotics and probiotics in recent 3 months.

Design outcomes

Primary

MeasureTime frame
Time to achieve 10% weight loss (weeks);

Secondary

MeasureTime frame
Changes in clinical phenotype of polycystic ovary syndrome;Changes in intestinal flora;Plasma metabolome (untargeted);Transcriptome of peripheral blood lymphocytes;

Countries

China

Contacts

Public ContactYin Guoshu

The First Affiliated Hospital of Shantou University Medical College

yinguoshu@126.com+86 3417029106

Outcome results

None listed

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